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12. Minority Activities


Throughout its history, the NHLBI has been a leader in conducting and supporting research to eliminate health disparities that exist between various segments of the U.S. population. The Institute has not only initiated research projects with significant minority participation in order to compare health status between various populations, but also given high priority to programs that focus exclusively on minority health issues.

Since FY 1991, the Institute has had procedures in place to ensure full compliance with the NIH Policy on Inclusion of Women and Minorities as Subjects in Clinical Research. As a result, all NHLBI-supported research that involves human subjects includes minorities, with the exception of a very few projects for which a compelling justification for limited diversity in the study population exists. Thus, all segments of the population, minority and nonminority, women, and children, stand to benefit from the Institute's research programs.

It has long been a goal of the NHLBI to increase the number of individuals from underrepresented groups in biomedical and behavioral research. Selected FY 2008 activities addressing this goal include the following:

  • Minority K–12 Initiative for Teachers and Students (MKITS): Supports research, development, and evaluation of innovative science training programs to provide minority students in grades K–12 with the exposure, skills, and knowledge that will encourage them to pursue advanced studies in biomedical and behavioral sciences.
  • Historically Black College and University (HBCU) Research Scientist Award and the Research Scientist Award for Minority Institutions: Strengthens the biomedical and behavioral research capabilities and resources of HBCUs or minority institutions by recruiting an established research scientist in areas related to cardiovascular, lung, or blood health and disease; transfusion medicine; or sleep disorders.
  • Sickle Cell Scholars Program: Supports career development of young or new investigators in SCD research as part of the BTRP.
  • Summer for Sickle Cell Science Program: Supports research training and mentoring of individuals at the high school level as part of the BTRP.
  • Clinical Research Education and Career Development in Minority Institutions: Encourages the development and implementation of curriculum-dependent programs in minority institutions to train selected doctoral and postdoctoral candidates in clinical research leading to a Master of Science Degree in Clinical Research or Master of Public Health Degree in a clinically relevant area.
  • Minority Undergraduate Biomedical Education Program: Encourages development of pilot demonstration programs at minority undergraduate educational institutions to recruit and retain talented undergraduate students in the biomedical sciences.
  • Summer Institute Program To Increase Diversity in Health-Related Research: Enables faculty and scientists from underrepresented racial and ethnic groups or with disabilities to advance their research skills and knowledge in basic and applied sciences relevant to heart, lung, and blood diseases and sleep disorders, so that they can compete for funding for scientific research in the biomedical and behavioral sciences.

The Office of Research Training and Minority Health (ORTMH) within the Office of the Director provides oversight for, and coordinates, supports, and evaluates Institute programs related to minority health outcomes, including research, research training and career development, public outreach, and translation of research findings. The ORTMH also coordinates activities to foster greater participation of underrepresented minorities in NHLBI research and research training and career development programs. Selected FY 2008 activities include the following:

  • Issuing four training and career development RFAs to increase the number of highly trained minorities conducting biomedical and behavioral research. Additional targeted groups include individuals from disadvantaged backgrounds and individuals with disabilities.
  • Participating in HHS-Endorsed Minority Organization Internship Programs by supporting positions in NHLBI extramural and intramural divisions for students from the National Association for Equal Opportunity in Higher Education, the Hispanic Association of Colleges and Universities, the Washington Internships for Native Students programs, and the Directors of Health Promotion and Education Internship Program/CDC.
  • Cosponsoring with the NIH, the Cherokee Elementary School Project: Out of the Box, which is designed to create awareness and interest in the importance of science, medicine, and health; eliminate gaps in quality of health among minorities by encouraging health-related careers; and encourage children to take responsibility for their own health.
  • Supporting the African American, Hispanic, and Native American Youth Initiatives to bring minority students to the NIH campus for scientific presentations, an introduction to NHLBI research training and career development programs, and a tour of NHLBI laboratories.
  • Providing undergraduate students from the Tougaloo College Scholars program an opportunity to learn about the NIH, biomedical research, and research training opportunities at the NHLBI during a 3-day tour of the NIH.
  • Serving as a Web site resource for recruitment of minority individuals into the Ruth L. Kirschstein Institutional National Research Service Award (T32).
  • Increasing recruitment of individuals for the NHLBI intramural and extramural training programs by representing the Institute at five minority-focused research meetings to raise awareness of research and research training and career development opportunities available from the NHLBI.
  • Coordinating the Biomedical Research Training Program for Individuals From Underrepresented Groups, which offers opportunities for underrepresented undergraduate, postbaccalaureate, and graduate students to receive training in fundamental biomedical sciences and clinical research as they relate to the etiology and treatment of heart, blood vessel, lung, and blood diseases and sleep disorders.
  • Serving as the NHLBI contact for guidance to candidates applying for the NIH Pathway to Independence (PI) Award (K99/R00) and the NHLBI Career Transition Award (K22) for extramural programmatic issues.

See Chapter 13 for additional NHLBI-supported minority research training and career development programs.

The following text describes selected current projects that focus on minority populations and reflect the Institute's research portfolio related to minority health. Additional information can be found in Chapters 9 through 11.

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Heart and Vascular Diseases

Risk Factors

Epidemiology

Long-term epidemiologic studies are critical to uncovering risk factors that lead to disease. The Institute has initiated several major studies of heart disease focused significantly or completely on minority populations.

  • CARDIA (see Chapter 10): To determine the evolution of CHD risk factors and lifestyle characteristics in young adults that may influence development of risk factors prior to middle age; 50 percent of the participants are black.
  • ARIC (see Chapter 10): To investigate the association of CHD risk factors with development of atherosclerosis and CVD in an adult population; 30 percent of the participants are black.
  • CHS (see Chapter 10): To examine risk factors for CHD and stroke in the elderly; 16 percent of the participants are black.
  • Strong Heart Study (see Chapter 9): To compare risk factor levels and morbidity and mortality from CVD among American Indians from three different geographic locations.
  • JHS (see Chapter 10): To identify environmental and genetic factors influencing evolution and progression of CVD in blacks.
  • MESA (see Chapter 10): To examine the characteristics of subclinical CVD that predict progression to clinically overt CVD and related risk factors that predict subclinical disease in blacks, whites, Hispanics, and Asians; 62 percent of the participants are minorities.
  • GOCADAN (see Chapter 9): To document CVD risk factors and measures of subclinical disease and to identify and characterize genes that contribute to CVD in approximately 40 extended Alaska Native families.
  • HCHS (see Chapter 10): To identify risk factors for cardiovascular and lung disease in Hispanic populations in the United States and determine the role of acculturation in their prevalence and development.

The Institute supports components of the NHANES that track the prevalence of disease and risk factors for cardiovascular and lung diseases by race and ethnicity in the U.S. population.

Several investigator-initiated epidemiologic studies are examining gene–environment interactions that increase CVD risk factors among various racial groups. Included among them are studies that compare gene–environment interactions in black populations in Africa, the Caribbean, and selected areas of the United States; determine the genes responsible for the metabolic syndrome, a risk factor for CVD, in 10,000 Chinese sibling pairs; determine the genes responsible for CVD risk factor response to dietary fat changes in blacks; and identify and map specific genes that contribute to CVD risk in Mexican Americans.

Scientific evidence is emerging that implicates cellular and inflammatory processes in the development and characteristics of atherosclerotic plaque and the clinical course of CVD. One study seeks to identify cellular, metabolic, and genomic correlates of atherosclerotic plaque characteristics and early changes in the vascular wall in a subset of the ARIC cohort; one-third of participants are black. Another study is elucidating the links between socioeconomic factors, stress, inflammation and hemostasis, and cardiovascular risk in a large and diverse population.

Several drugs in four widely used classes of noncardiovascular medications (fluoroquinolone and macrolide antibiotics, antipsychotics, and antidepressants) have been shown to be proarrhythmic and thus increase the risk of sudden cardiac death. Investigators are conducting a study, using a large and comprehensive dataset of about 800,000 persons, 40 percent of whom are black, to understand the role of those medications on the risk of sudden cardiac death. Research findings are expected to provide information that will enable clinicians to prescribe these widely used medications in a way that minimizes the risk of sudden cardiac death.

Ancillary studies to MESA are investigating subclinical CVD in ethnic minority groups. They include investigations of regional left ventricular function, progression of calcification in the aorta, abnormalities in the small vessels of the retina, association of air pollution and subclinical CVD, lung function in relation to endothelial dysfunction and biomarkers, identification of genes for subclinical CVD, and relationships of sociodemographic factors and other factors to subclinical CVD.

The Institute is supporting additional epidemiologic investigations that include a project to use pooled data from nine existing U.S. studies to compare between blacks and whites, CHD incidence and mortality rates, exposure–outcome relationships, patterns of comorbidity, and population attributable risk; and a study to evaluate and compare the extent of atherosclerosis and risk factors for CHD in three different populations: U.S. (75 percent white and 25 percent black), Japanese Americans in Hawaii, and Japanese in Japan.

Treatment and Prevention

Low-dose aspirin is cost effective and efficacious for the prevention and treatment of CHD. However, some individuals, perhaps because of individual genetic variations, do not respond to the treatment. A genetic study in high-risk siblings of patients with premature CHD, along with their adult offspring, is seeking to determine whether low-dose aspirin responsiveness is heritable and whether it is associated with specific variations in candidate genes or defined haplotypes; 50 percent of the participants are black.

Although great progress has been achieved in reducing CVD morbidity and mortality in the United States over the past 40 years, minorities have not shared fully in the progress and continue to have higher CVD morbidity. To address this problem, the Institute has initiated programs directed at reducing cardiovascular health disparities:

  • Partnership Programs To Reduce Cardiovascular Disparities (see Chapter 9): To expand the capacity of research institutions to reduce health disparities, encourage more researchers to focus on minority health, and improve minority acceptance and community willingness to participate in research by pairing research-intensive medical centers that have a track record of NIH-supported research and patient care with minority health care serving institutions that lack a strong research program and are the primary source for care of minorities. Researchers are examining the complex biological, behavioral, and societal factors that result in cardiovascular health disparities in their target populations (e.g., blacks, Hispanics, Native Hawaiians, Pacific Islanders).
  • Cultural Competencies and Health Disparities Academic Award Program: To enhance the ability of physicians and other health care professionals to address, in a culturally sensitive manner, disparities in the occurrence, management, and outcomes of cardiovascular, lung, and blood diseases and sleep disorders among various population groups in the United States. The award addresses ethnic, cultural, religious, socioeconomic, linguistic, and other factors that contribute to health disparities and seeks culturally competent approaches to mitigating them.
  • Community-Responsive Interventions To Reduce Cardiovascular Risk in American Indians and Alaska Natives: To test the effectiveness of culturally appropriate behavioral interventions that promote adoption of healthy lifestyles (healthy diet, regular physical activity, smoking cessation, and stress management) related to heart disease and stroke risk in American Indians and Alaska Natives.

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Education

The NHLBI, through the DARD, seeks to translate research findings into practice by communicating research advances effectively and disseminating health information to physicians, health care professionals, patients, and the public on ways to prevent or treat diseases within the Institute's mandate. The Division has developed the following community-based programs to combat cardiovascular health disparities among five major cultural/ethnic groups: blacks, Hispanics, American Indians and Alaska Natives, Asian Americans, and Native Hawaiians and other Pacific Islanders:

  • Public Health in Public Housing Community Outreach: Improving Health, Changing Lives: To disseminate information about improving cardiovascular health by adopting heart healthy lifestyles to populations residing in public housing.
  • NHLBI-Health Resources and Services Administration Bureau of Primary Care Partnership: To integrate clinical care management teams and trained community health educators to implement pilot programs for blacks, Latinos, Asian Americans, and Native Hawaiians and other Pacific Islanders who are at high risk for CVD.
  • Salud para su Corazón: To disseminate information on CVD prevention, intervention, and treatment and promote heart healthy behaviors in Hispanic communities through lay health educators (promotores model).
  • NHLBI-Pan American Health Organization/WHO Partnership To Promote Cardiovascular Health in the Americas: To develop and evaluate community-based interventions to prevent and control CVD risk factors among low-resource communities in Argentina, Chile, and Guatemala using lay health workers (promotores de salud). Research results will be shared with country health authorities and the members of the CARMEN Network: an Initiative for Integrated Prevention of Noncommunicable Diseases in the Americas.
  • Honoring the Gift of Heart Health: To develop and evaluate community-based interventions to prevent and control CVD risk factors through education and outreach using tribal community health workers and community health educators.
  • Healthy Heart, Healthy Family: To develop and evaluate culturally and linguistically appropriate outreach activities and information to increase community awareness of heart disease and its associated risk factors and to promote heart healthy lifestyles among the growing Filipino American population.
  • The Heart Truth Campaign: To raise awareness of heart disease in women through community-based interventions. Campaign goals include outreach to women of color through educational materials addressed to special populations and partnerships with national African American and Hispanic organizations.
  • Stay in Circulation: Take Steps to Learn About P.A.D.: To increase public and health care provider awareness of P.A.D. and its association with other CVD. The NHLBI has developed and disseminated information through partnerships with faith-based organizations and media outlets. Special attention is directed to minority and Hispanic populations.

In addition to the activities mentioned above, the Institute has prepared publications on CVD prevention for minority populations. They include the following:

  • On the Move to Better Heart Health for African Americans
  • Your Heart is Golden: Heart Health Promotion Activities for Vietnamese Communities
  • Healthy Homes, Healthy Hearts Series. Six easy-to-read English and Spanish booklets on heart healthy living.
  • Bringing Heart Health to Latinos: A Guide for Building Community Programs
  • Your Heart, Your Life: A Health Educator's Manual for the Latino Community
  • Vietnamese Aspire for Healthy Hearts in Vietnamese and English
  • Honoring the Gift of Heart Health: A Heart Health Educational Manual for American Indians and Alaska Natives
  • With Every Heartbeat is Life: A Community Health Worker's Manual for African Americans
  • The Heart Truth for African American Women: An Action Plan
  • Su Coraz?n, Su Vida: A Community Health Worker's Manual for Latinos
  • The Heart Truth for Latinas: An Action Plan
  • Healthy Heart, Healthy Family: A Community Health Worker's Manual for the Filipino Community in English and Tagalog
  • Facts About Peripheral Arterial Disease (P.A.D.) for African Americans
  • Información acerca de la enfermedad arterial periférica (P.A.D.)

The educational materials listed throughout this chapter can be obtained from the NHLBI public Web site or through the NHLBI online catalog.

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Arrhythmias

The NHLBI is supporting basic and genetic research on the mechanisms that underlie cardiac arrhythmias to improve diagnosis, treatment, and prevention of arrhythmias in all ethnic and racial groups in the United States.

Prolongation of electrocardiographic QT interval is a risk factor for sudden cardiac and individuals with diabetes are known to have increased risk for prolongation of electrocardiographic QT interval. In one study replicating the association of two common genetic variants with prolonged QT interval in a population predominately of individuals (624 European Americans and 127 blacks) with type 2 diabetes, researchers found strong association in the European American sample, but no association in the limited number of blacks. Testing in large numbers of blacks will be required to confirm this result.

Another study identified two mutations in a gene encoding the major intracellular calcium release channel in two cases of sudden infant death syndrome (SIDS). One mutation was identified in 1 out of 50 (2%) black infants and the other in 1 out of 83 (1.2%) white infants. Researchers report a pathogenic mechanism for SIDS, whereby SIDS-linked mutant ion channels become "leaky" during stress and thus potentially trigger fatal cardiac arrhythmias. They have importantly added further evidence that cardiac arrhythmias of genetic origin contribute to SIDS, a concept that offers a chance to prevent some avoidable tragedies.

A third study identified an association between variations in certain receptors that are activated during sympathetic nervous system stimulation and an increased risk of sudden cardiac death, most often due to ventricular arrhythmia. Although no significant differences were found between blacks and whites in associated risk of sudden cardiac death, continued research in this area is expected to advance understanding of differences in genetic predisposition for cardiac arrhythmias among ethnic and racial groups and ultimately lead to improved therapy.

Heart Failure

Heart failure (heart muscle dysfunction) affects about 5 million Americans of all ethnicities and is a growing public health concern. It is frequently the end result of other conditions, such as hypertension, diabetes, and prior heart attacks.

The NHLBI is supporting basic and clinical research associated with heart failure that will benefit Americans of all ethnicities. One project focuses on Native Hawaiians and the other has a minority component:

  • Heart Failure Disparities in Native Hawaiians: To characterize ethnic differences in patients hospitalized for heart failure, determine whether a culturally competent educational program can reduce hospitalizations, and compare the effectiveness of early diagnosis in high-risk patients by using community-based portable echocardiography to hospital-based echocardiography performed by professional sonographers. The project is within the Partnership Programs To Reduce Cardiovascular Disparities Initiative (see page 132).
  • Heart Failure Clinical Research Network (see Chapter 9): To develop, coordinate, and conduct multiple collaborative proof-of-concept clinical protocols to improve heart failure outcomes. The Network has been expanded to include a historically black medical center with minority investigators and access to a high-risk, underserved population.

Other research targeting minority populations includes an investigation of genetic variations (especially those common in blacks) that affect individual responses to the beta blocker drugs used to treat heart failure and identification of underlying genetic variations that result in familial dilated cardiomyopathy, an inherited form of heart dysfunction; five black families are participating. Another study is focusing on angioedema or severe allergic reaction, a life-threatening side effect of ACE-inhibitor drugs that is more common in blacks than in whites. Investigators are determining the mechanisms that cause the side effect and studying the genetic profile of affected individuals and their families to determine who should avoid taking the drugs.

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High Blood Pressure

Etiology and Pathophysiology

High blood pressure is a serious health problem that is especially prevalent and severe among minorities. An Institute-initiated study is seeking to determine the etiology and pathophysiology of high blood pressure:

  • Family Blood Pressure Program (see Chapter 9): To use a network of investigators to identify genes associated with high blood pressure and to examine interactions between genetic and environmental determinants of hypertension in specific minority populations: Asians, blacks, and Mexican Americans.

The NHLBI supports a number of investigator-initiated studies to identify genes linked to hypertension in blacks, Mexican Americans, and whites to determine if part of the disparity in prevalence can be attributed to genetic differences among the groups. Genes under investigation include those associated with the renin-angiotensin system, the autonomic nervous system, and sodium transport.

The Institute supports a number of projects to examine antecedents of hypertension in children to determine racial differences in blood pressure regulation. One study is determining relationships between cardiovascular reactivity in adolescent normotensive blacks and development of pathobiologic markers of hypertension risk (i.e., increased resting blood pressure, left ventricular mass, and relative wall thickness) later in life. Another is investigating the genetics of cardiovascular reactivity following stress in black youth.

Researchers also are examining the influence of SES and ethnic discrimination on stress reactivity to determine if it provides a pathophysiologic link to CVD in blacks. One group is examining the combined influence of low SES and ethnicity on development of behavioral risk factors (i.e., hostility, anxiety, heightened cardiovascular reactivity to stress) in a group of adolescents; 50 percent of them are black. Another group is assessing the relationship between early life exposure to socioeconomic stressors—such as adverse socioeconomic conditions, low levels of social integration, and racial discrimination—and development of hypertension in blacks.

Investigators have observed that blacks have an exaggerated blood pressure response to salt. A study to improve understanding of the biological basis of salt-sensitive hypertension in blacks has located a molecule that transports sodium in a specific region of the kidney where sodium is reabsorbed to a greater extent in blacks than in whites.

Impaired sodium regulation also appears to be linked to the development of hypertension. In a twin study consisting of 41 percent blacks, scientists are investigating sodium retention as a mechanism augmenting systemic vascular resistance and changes in vascular function, ventricular structure, and blood pressure. In another study, scientists are investigating the effects of stress on salt retention and measuring hormonal variables known to influence sodium regulation.

A third study is seeking to determine whether the mechanisms regulating sodium retention differ between blacks and whites. Researchers found that black youths have a slower salt excretion rate in response to stress than white youths. New data suggest that obesity may contribute to the racial differences in response to stress. A study among blacks living in three different environments (Nigeria, Jamaica, and Chicago) is examining the role of sodium and obesity in hypertension development.

The role of dietary factors, particularly macronutrients, in the etiology of high blood pressure is another area of investigation. Scientists are conducting epidemiologic studies among participants with diverse ethnicity, SES, and dietary habits in four countries to determine the effect of selected dietary components (proteins, lipids, carbohydrates, amino acids, calcium, magnesium, sodium, potassium, antioxidants, fiber, caffeine) on blood pressure. Another study is seeking to identify the link between healthy diet, genetic factors, and their underlying biological mechanisms.

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Treatment and Prevention

Identifying effective treatment strategies for various populations requires large-scale studies in representative populations with sufficient numbers.

  • Ancillary Pharmacogenetic Studies in Heart, Lung, and Blood Diseases and Sleep Disorders: To conduct pharmacogenetic studies in ongoing or completed clinical trials/studies related to heart, lung, and blood diseases and sleep disorders to examine genetic influences on inter-individual differences in prescription drug response. Understanding the genetic influences may permit improved medication choice and dosing for individuals and help avoid either serious adverse response or poor response to therapy. Three of the studies focus on antihypertensive drugs and include 50 to 58 percent blacks.

An investigator-initiated ancillary study to ALLHAT, the largest hypertension clinical trial conducted by the NHLBI, is evaluating the pharmacogenetic response to antihypertensive treatment and long-term clinical complications in blacks, whites, and Hispanics. Scientists are seeking to determine whether pharmacogenetics is a feasible approach to personalized therapy for hypertension.

Although it is well known that reducing hypertension will reduce CVD rates, the implementation of evidence-based guidelines for hypertension treatment in clinical practice is disappointing. To address this issue, the NHLBI initiated a program to improve hypertension control rates in blacks, a group with the highest prevalence and earliest onset of hypertension and with disparately high premature cardiovascular mortality and morbidity:

  • Interventions To Improve Hypertension Control Rates in African Americans: To evaluate the feasibility of clinical interventions directed at the medical care delivery system to increase the proportion of blacks who have their blood pressure controlled to levels specified by the JNC VII guidelines. Nearly 3,900 black patients are being enrolled in community-based projects to evaluate interventions such as pharmacy- and visiting nurses association-based approaches, telemanagement, and patient and physician education.

The Institute also supports a number of investigator-initiated studies to prevent hypertension and improve blood pressure control in ethnic and racial minorities. Interventions target both lay and medical communities. Strategies being tested include communication skill enhancement, organizational change, educational programs, lifestyle and nutritional counseling, use of technology, case management, pharmacy-based interventions, and provision of care by community health workers and other nontraditional providers.

Anger and hostility have been shown to be risk factors for hypertension. Scientists are evaluating an anger management intervention in a hospital setting to determine whether it will reduce blood pressure and alleviate psychosocial risk factors (e.g., reduce depression); 46 percent of the participants are black.

Understanding racial differences in blood pressure control is an area of major interest for the Institute. Scientists are examining whether variations in genes of the renin-angiotensin-aldosterone system predict differences in blood pressure response to diuretic therapy among hypertensive blacks and whites. Research also is being focused on variations in the ACE gene between blacks and whites to explain racial differences in the antihypertensive responsiveness to ACE inhibitors.

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Education

The NHLBI has developed a number of outreach activities to inform minority populations of the importance of blood pressure control. Included among them are a toll-free number that provides materials on hypertension in English or Spanish; mini telenovelas (Más vale prevenir que lamentar), "health moments" to reinforce CVD prevention for local Spanish-language television stations; a Spanish version of the High Blood Pressure Education Month Kit; and several publications and Web-based products for health professionals, patients, and the public. Some examples are:

  • Plan de Alimentación Saludable Contra la Hipertensión: Prevenir y Controlar la Presión Arterial Alta Siguiendo el Plan de Alimentación Conocida Como DASH (DASH to the Diet: Prevent and Control High Blood Pressure Following the DASH Eating Plan)
  • Presión arterial alta: NHLBI Health Topics
  • Sí se Puede: Prevenir y Controlar la Presión Arterial Alta: Lo Que Usted Debe Saber Sobre la Preventión y Control de la Presión Arterial Alta (Prevent and Control High Blood Pressure: What You Should Know)
  • Sí se Puede: Prevenir y Controlar la Presión Arterial Alta. Lo Que los Médicos Deben Saber (Prevent and Control High Blood Pressure. What Every Physician Should Know)
  • Keep the Beat: Control Your High Blood Pressure in English and Spanish
  • Churches as an Avenue to High Blood Pressure Control
  • Working With Religious Congregations: A Guide for Health Professionals
  • Help Your Heart: Control Your High Blood Pressure in Tagalog and English
  • Keep Your Heart in Check—Know Your Blood Pressure Number in Vietnamese and English
  • Prevent and Control High Blood Pressure: Mission Possible.

NHBPEP Coordinating Committee Activities

Member organizations of the NHBPEP coordinating committee have continuing education programs on the prevention and treatment of hypertension that are focused on their minority members. They are also involved with outside activities that include designing public health interventions to address excessive stroke mortality in the Southeastern United States; publishing reports about best treatment practices to control hypertension; conducting demonstration projects at the work site and in urban and rural settings; developing reports and intervention programs regarding hypertension among special populations or situations (e.g., blacks, patients who are hypertensive and have renal disease or diabetes, children, older Americans); and promoting population strategies for the primary prevention of hypertension.

High Serum Cholesterol

Etiology

The Institute supports a number of investigator-initiated projects to identify genes that influence the lipoprotein profile within various racial and ethnic groups. Research findings could offer an explanation for differences in susceptibility to CHD found among various racial and ethnic groups.

Variation in hepatic lipase activity is associated with differences in plasma concentrations of HDL and LDL synthesis and catabolism. Researchers are investigating whether ethnic differences in hepatic lipase activity are responsible for the well-known differences in plasma HDL concentrations found in blacks and whites. Genetic studies are being conducted on a population that is 39 percent black.

Prevention

The NHLBI is supporting an investigator-initiated study among minority preschool children to track the long-term effectiveness of nutrition interventions on diet and blood cholesterol levels. Additional potential risk factors such as increased blood pressure, obesity, and intention to smoke, will also be monitored.

Education

The Institute has prepared the following publications on blood cholesterol for minority audiences:

  • Do You Know Your Cholesterol Levels? in English and Spanish
  • Heart-Healthy Home Cooking African American Style
  • Delicious Heart-Healthy Latino Recipes
  • American Indian and Alaska Native People: Treat Your Heart to a Healthy Celebration!
  • Be Heart Smart: Keep Your Cholesterol in Check in Tagalog and English
  • Serve Up a Healthy Life—Give the Gift of Good Nutrition in Vietnamese and English.

Obesity

Etiology

Recent NHANES data show a continued rise in the proportion of Americans who are overweight; black women are especially at risk. Results from the NHLBI Growth and Health Study (NGHS) that examined the development of obesity and CVD risk factors in a bi- racial cohort of young girls found black girls consumed more calories and a higher percentage of calories from fat and watched more television than white girls. An investigator-initiated study using the NGHS cohort, starting at ages 18 to 19 years, is examining the changes in cardiac output and total peripheral resistance, which occur with developing obesity, and their influence on ethnic difference in blood pressure regulation. Another project, using data from the NGHS, is examining CHD risk factors in black and white girls to identify genes involved in black–white differences in lipid metabolism and obesity.

Black women have been shown to manifest lower resting energy expenditure than white women. Scientists seeking to improve our understanding of ethnicity, genetics, energy metabolism, and obesity development are examining the relationship between two genes implicated in energy metabolism and resting energy expenditure in high-risk blacks.

Menopause-related coronary risk was previously believed to be associated with a gain in total body fat. Research, however, suggests that the location of the fat, not the total fat per se, is the key risk factor. An investigator-initiated study is seeking to determine if indices of central adiposity, particularly intra-abdominal fat, predict coronary events better than indices of total fat. The study is also examining the role of central a adiposity with altered glucose and lipid metabolism and elevated blood pressure; 48 percent of the participants are black.

Treatment and Prevention

The NHLBI has initiated programs to test approaches for treating or preventing obesity.

  • Overweight and Obesity Control at Worksites: To test innovative interventions that emphasize environmental approaches or the combination of environmental and individual approaches at worksites to prevent or treat obesity in adults. Environmental strategies include programs, policies, or organizational practices (e.g., increasing the availability of, and providing access to, healthful food choices and facilities for physical activity, and creating a socially supportive climate to influence healthy behaviors). Targeted groups for some projects include individuals from underrepresented racial and ethnic groups.
  • POUNDS LOST (see Chapter 9): To evaluate the effectiveness of four diets differing in macronutrient composition to promote and sustain weight loss in overweight and obese individuals; 17 percent of the participants are from minority populations.
  • WLM (see Chapter 9): To determine the effectiveness of continuous patient contact on weight loss maintenance in adults who recently lost weight; 40 percent of the patients are black.
  • POWER (see Chapter 11): To test the effectiveness of interventions delivered in routine clinical practice on achieving weight loss in obese patients who have other CVD risk factors (e.g., hypertension). One study focuses on a low-income minority population.

The Institute supports a number of investigator-initiated studies on the effectiveness of obesity prevention and control interventions among diverse populations. One study is testing the effectiveness of weight-control interventions (involving diet, physical activity, psychosocial and familial influences) administered during the critical transition period from prepuberty to puberty in black girls at high risk for obesity. Another study in preadolescent black girls is evaluating the efficacy of an after-school dance program and a family-based intervention involving reduced use of television, videotapes, and video games to reduce weight gain.

Two studies are evaluating the effectiveness of weight control programs to prevent weight gain in a predominately black population that has recently completed a smoking cessation program. The blood pressure status of the participants, who are prehypertensive or hypertensive at the beginning of the studies, are being monitored.

Blacks at high risk of CVD often have limited success in weight loss and lifestyle change programs. A study was initiated to examine the role of social support, particularly from family members and friends, to facilitate weight loss and related dietary and physical activity changes in blacks.

Hispanics are also an important population targeted for intervention programs. One project is studying the effects of physical activity and dietary behaviors in a microenvironment (i.e., home environment) and in a macroenvironment (i.e., apartment complex, schools, grocery stores, parks, restaurants). Community health workers (promotoras) are working with the families and the community to increase awareness and promote environmental change. Another project with strong Hispanic participation is evaluating how well an intervention, Planned Care for Obesity and Risk Reduction, supports primary care treatment of obesity in adults with at least one other cardiovascular risk factor. The study is seeking to improve the way primary care providers offer services to their patients who are overweight and who also have other important medical conditions or health risks such as hypertension, smoking, or high cholesterol.

A project with a subject population consisting of Asians, Hispanics, and whites is testing an integrated school- and community-based intervention involving physical activity and diet to reduce the prevalence of obesity.

In a study among Hispanic adolescents, researchers are developing new instrumentation for evaluating the effects of overweight or obesity on adverse metabolic effects (such as insulin resistance) or autonomic nervous system disturbances (such as sleep disordered breathing), which may precede diabetes or hypertension.

Obesity is one of the major health challenges facing Native American children and has serious implications for the development of type 2 diabetes. A school-based intervention, augmented with a family intervention, is focusing on reducing excess weight gain by increasing physical activity and healthy dietary practices in kindergarten and first-grade Native American children.

Education

The NHLBI has prepared health information on losing excess weight for minorities:

  • Do You Need To Lose Weight? in English and Spanish
  • Embrace Your Health! Lose Weight if You Are Overweight.
  • Keep the Beat: Aim for a Healthy Weight in Tagalog and English
  • We Can!™ (Ways to Enhance Children's Activity & Nutrition): Many bilingual (English and Spanish) publications on energy balance are available on the Web site.

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Physical Inactivity

Physical inactivity among children is often attributed to the lack of open space, lack of recreational equipment, and fear by parents for the safety of children playing outdoors. A study is being conducted to determine if an intervention that changes these neighborhood features in a low-income, inner-city neighborhood will increase physical activity in children.

Scientists have observed an age-related decline in aerobic capacity, but have not been able to discern the effects of physical activity, body fat, and genetic variation on its rate of change. They also have little understanding about how the rate of change in aerobic capacity during early and middle adulthood affects the development of CVD. An ancillary, investigator-initiated study being conducted in conjunction with the Year 20 CARDIA examination is addressing these issues. Data from this study should increase understanding of the interrelationships of cardiorespiratory fitness, body composition, and CVD-related risk factors and endpoints, and may provide the basis for more extensive evidence-based recommendations on the role of fitness in cardiovascular health; 45 percent of the participants are black.

A project in the field of bioengineering and obesity is seeking to develop better measurement techniques for assessing levels of activity and the impact of inactivity on overweight and obese children. Carried out in an approximately 50 percent black population, this project is developing and testing devices that can precisely measure activity levels in highly sedentary overweight or obese adolescents.

Education

The Institute has prepared the following publications for minorities on the importance of physical activity and ways to become more physically active:

  • Energize Yourself! Stay Physically Active
  • Sí se Puede: Prevenir y Controlar la Presión Arterial Alta con Actividad Física (Move To Prevent and Control High Blood Pressure With Physical Activity)
  • American Indian and Alaska Native People: Be Active for Your Heart!
  • Are You at Risk for Heart Disease? in Tagalog and English
  • Be Active for a Healthier Heart in Vietnamese and English.

The Institute also has developed a Web-based application on physical activity for lay health educators in English and Spanish, which can be found at http://hin.nhlbi.nih.gov/salud/pa/index.htm.

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Smoking

Smoking is a major risk factor for CHD and stroke and is the leading cause of preventable death. Although great progress has been made in smoking cessation programs, maintenance of behavior change has been limited. To address this problem, the Institute is supporting several investigator-initiated smoking intervention and follow-up cessation maintenance studies. One study targets low-income, high-risk women from a variety of ethnic and racial backgrounds who have quit smoking because of their pregnancy. It is comparing the biochemically confirmed smoking abstinence rates of women who quit smoking during their pregnancy and who receive intervention-based telephone counseling with the rates of quitters who receive usual care. Maintenance of abstinence will be assessed at 1, 3, 6, and 12 months postpartum.

Another study targets respiratory therapists and nurses who provide hospital-based tobacco cessation interventions to parents of hospitalized pediatric patients with respiratory illness. It focuses on refining an interactive Internet-based program, WeBREATHe (Web-Based Respiratory Education About Tobacco and Health); evaluating the program for use in children's hospital settings in a randomized trial of respiratory therapists and nurses assigned to either the Training Condition (WeBREATHe program) or a Delay Training Control condition; and developing a final version of the interactive training program with manuals. Forty-two percent of the participants are expected to come from minority populations.

Obesity and smoking are risk factors for hypertension. Typically, smokers who succeed in quitting tend to gain excess weight, which may exacerbate existing hypertension. Intervention programs for smokers who are hypertensive need to include a weight loss component. Two studies in smokers with hypertension will compare the effectiveness of a pharmacologic smoking cessation intervention followed by a weight gain prevention and blood pressure control program consisting of changes in dietary intake and physical activity to the same smoking cessation intervention followed by general health education. At a 1-year follow-up session, researchers will compare the changes in blood pressure, body weight, dietary intake, physical activity, hypertensive status, and medication status between the two groups. Sixty percent of the participants are expected to be black.

Smoking prevalence among active duty military personnel is high, especially among young recruits and those in the Marines where the rate is almost 40 percent. Because of the unique challenges such as high troop mobility, remote locations, and limited access to health care services, many interventions that have shown strong efficacy in civilian populations often fail in military populations. One program, Tobacco Quit Lines, is a promising and widely disseminated approach that can address many of the issues, such as troop mobility and remote access, associated with the military. An investigator-initiated study is seeking to determine the long-term (1-year) efficacy of an interventionist versus a Reactive Quit Line intervention; 28 percent of the population is expected to come from minority populations.

Smoking rates among the homeless population are extremely high, with estimates of 70 percent or more. Two of the three major causes of death among the homeless are heart disease and cancer, both of which are?tobacco related. Recent studies have shown that many homeless smokers are ready to quit smoking. Maintenance of smoking cessation, however, is rather low. The Institute is supporting a study to compare smoking abstinence at 6 months among homeless participants who received nicotine patches for 8 weeks: the intervention group received five counseling sessions encouraging adherence, and the control group received advice to quit in one brief session.

The estimated prevalence of smoking among individuals with HIV is approximately 50 percent. As they age, they are at an increased risk of smoking-related lung damage. Investigators are developing and evaluating a specialized smoking cessation intervention for nicotine-dependent HIV smokers. The study also will examine the effects of smoking cessation on the course of lung function decline, prevalence of respiratory symptoms, and occurrence or progression of emphysema in a cohort of HIV individuals; 38 percent of the participants are expected to be black.

Education

The Institute has prepared the following publications on smoking cessation for minorities:

  • Enjoy Living Smoke Free in English and Spanish
  • Refresh Yourself! Stop Smoking
  • American Indian and Alaska Native People: Help Your Heart
  • Be Heart Healthy: Enjoy Living Smoke Free in Tagalog and English
  • Don't Burn Your Life Away—Be Good to Your Heart in Tagalog and English and in Vietnamese and English.

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Psychosocial Factors

Major depression is a risk factor in the development of ischemic heart disease and for death after an acute MI. Investigator-initiated research is seeking to determine the pathways that link depression to physiological mechanisms in patients who are post-MI. One study is examining the link between the severity of depressive symptoms to the inflammatory process implicated in atherogenesis by focusing on the basal expression of cytokines and cell adhesion molecules on blood monocytes. Another study is focused on the autonomic nervous system and its link to depression. A third study is investigating the role of platelets, platelet aggregation, and adhesion in patients with major depression. Approximately 30 percent of the participants in the studies are black.

The NHLBI is interested in the effect of depression, anxiety, and lack of social support on prognosis after a CHD event. An investigator-initiated study is examining the efficacy of individual and group therapy in patients who are post-MI and socially isolated or clinically depressed. Scientists will be measuring biological risk factors (e.g., lipids, adiposity, coagulation factors) and possible subclinical markers of disease (e.g., carotid intimal-medial thickness, coronary calcification); 34 percent of the participants are black.

The Institute supports investigator-initiated research on the role of race and ethnicity, psychosocial and environmental factors, and low SES in the development of CHD. Scientists are investigating the contribution of biobehavioral factors (hostility, anxiety, and heightened cardiovascular reactivity to stress) in the etiology, pathogenesis, and course of CHD. Racial differences in stress-induced physiologic responses also are being examined. Other investigators are focused on the relationships of psychosocial stress, sleep disordered breathing, and nocturnal physiological measures with emerging risk factors and subclinical CVD; 50 percent of the participants are black.

Although psychosocial risk factors such as depression, hostility, and stress have been associated with CVD, their role in stroke incidence and mortality has not been determined. An investigator-initiated study is seeking to determine whether psychosocial risk factors (depression, stress, hostility, perceived discrimination) or living in stressful neighborhoods are associated with increased risk of incident stroke and stroke mortality in a biracial population. Scientists will also compare the risk of stroke in blacks and whites and examine the degree to which racial differences in stroke risk are mediated by psychosocial risk factors.

Investigators are interested in the effects of race and psychosocial factors, such as hostility, on glucose metabolism. A study was initiated to determine how hostility is differentially related to glucose metabolism in blacks and whites. Research findings may increase understanding of the differences in the etiology of diabetes in the two groups.

Additional areas of interest include the genetic basis of aggression and the relationships between risk-promoting variables (psychosocial stress, smoking, poor diet, physical inactivity), presumed mediating variables (sympathetic nervous system activity and insulin metabolism), and CHD risk factors; 50 to 60 percent of the participants are black or Hispanic.

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Diabetes

Diabetes mellitus is a strong risk factor for CVD. Its prevalence is increasing due to the significant increase of obesity and physical inactivity in the population, especially among blacks, Hispanics, and American Indians. To address this growing problem, the Institute is supporting an investigator-initiated study on defining the relationship between the overall dose of endurance exercise training and the corresponding response of metabolic risk factors in an overweight and obese biracial female population. Another study will determine if adolescents with type 2 diabetes have a high risk of developing clinical CVD in their late 20s or 30s. Scientists are using noninvasive imaging techniques for detecting subclinical atherosclerosis to measure CVD development in a predominantly black population.

Hypertension and diabetes are major contributors to CVD and occur disproportionately in blacks. In particular, black women seem to have earlier disease onset and poorer outcomes. Scientists are investigating the link between hypertension and type 2 diabetes and the relative excess of androgen found in black women to determine whether insulin resistance, excess androgen, and endothelial dysfunction contribute to accelerated vascular injury in blacks.

Treatment

The NHLBI supports clinical trials to determine the benefits of various strategies to reduce CVD among patients with diabetes or treat patients with coronary artery disease and diabetes.

  • ACCORD (see Chapter 11): To evaluate the benefits of different therapies to reduce CVD in type 2 diabetes; more than 33 percent of the participants are minorities.
  • BARI 2D (see Chapter 9): To evaluate whether urgent revascularization offers an advantage over medical therapy in patients with coronary artery disease and diabetes. In addition, for a given level of glycemic control, to determine whether insulin-providing drugs offer advantages or risks compared to insulin sensitizers (drugs that enhance insulin action); 33 percent of the participants are from minority populations.
  • SANDS (see Chapter 9): To compare intensive treatment (pharmacologic agents, such as ACE inhibitors and simvastatin for high blood pressure and LDL cholesterol) to conventional treatment in 549 American Indians, aged 40 years or older, with diabetes. The primary endpoint is a combination of measures of carotid intimal-medial thickness and cardiovascular events such as heart attacks or strokes.

An investigator-initiated study is evaluating the effectiveness of a multiple risk factor intervention (diet, exercise, stress management, social support, smoking cessation) targeting postmenopausal Hispanic women with type 2 diabetes.

Education

The Institute has prepared the following publications on diabetes for minorities:

  • Protect Your Heart Against Diabetes in English and Spanish.
  • Protect Your Heart: Prevent and Control Diabetes in Tagalog and English

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Women's Health Initiative

CHD, cancer, and osteoporosis are the most common causes of death, disability, and impaired quality of life in postmenopausal women. The WHI (see Chapter 11) is addressing the benefits and risks of hormone therapy, changes in dietary patterns, and calcium/vitamin D supplements in disease prevention. Several of the centers have recruited primarily minority populations: American Indians, Asians, blacks, Hispanics, and Pacific Islanders. The clinical trial recruited 12,607 minorities and the observational study recruited 15,658. Overall, of the 161,808 postmenopausal women recruited into the WHI, 17 percent were minorities.

The Institute awarded 12 new contracts in 2007 to help explain the postmenopausal hormone therapy and other clinical trial findings and to investigate the effects of genetic and biological markers on common diseases affecting postmenopausal women. Investigators will conduct their research using blood, DNA, and other biological samples and clinical data from WHI participants. Four contracts focus specifically on minority women:

  • Physical Activity, Obesity, Inflammation, and CHD in a Multi-Ethnic Cohort of Women: To clarify the mechanisms underlying the reduced risk of CHD conferred by physical activity and lower body fat, beyond their effects on traditional risk factors. Using data from the WHI observational study, researchers will examine the association of physical activity and inflammatory markers and determine whether the association varies by a person's weight; and investigate the association between physical activity combined with weight/obesity status and risk of CHD. They will compare the role of inflammatory markers in mediating the associations of physical activity combined with weight with CHD risk to the role of traditional risk factors, such as blood pressure and cholesterol levels.
  • Ancestry Association Analyses of WHI Traits: To determine the contribution of ancestry informative markers in DNA samples to differences in risk of CHD, stroke, breast cancer, and hip fractures in blacks and Hispanics and analyze genetic factors related to ancestry or country of origin affecting hip fracture and bone mineral density in whites and blacks.
  • Biochemical Antecedents of Fracture in Minority Women: To examine biochemical factors for fracture in minority and white women. Research results could explain differences in fracture rates and contribute to prevention strategies.
  • Interaction Effects of Genes in the Inflammatory Pathway and Dietary Supplement and Medication Exposures on General Cancer Risk: To identify genetic variants in genes involved in inflammation and immunity that are associated with cancer risk (breast, colon and rectum, and lung) in whites and blacks. Scientists will test associations between the use of dietary supplements and nonsteroidal anti-inflammatory drugs (NSAID) with inflammatory markers and risk of overall cancer. They will then study interaction effects of genetic variants with dietary supplement and NSAID exposure on cancer risk.

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Lung Diseases

The NHLBI supports research on a number of lung diseases, such as asthma, COPD, sarcoidosis, TB, and HIV-related lung diseases, which disproportionately affect minorities. The following section provides examples of research to address health disparities in lung diseases; selected sleep disorders are also included.

Asthma

Asthma is a chronic lung disease that inflames and narrows the airways. It affects people of all ages, but it most often starts in childhood. In the United States, more than 22 million people are known to have asthma and nearly 6 million are children.

Etiology and Pathophysiology

The NHLBI has initiated several studies to determine the etiology and pathophysiology of asthma.

  • Severe Asthma Research Program: To determine the mechanistic basis for severe asthma and to determine how it differs from mild-to-moderate asthma. Several of the projects have strong minority participation.
  • Asthma Exacerbation: Biology and Disease Progression: To elucidate the biologic mechanisms of asthma exacerbation pathobiology and resolution and to determine their effect on lung function, physiology, and disease state; 27 to 56 percent of the study participants will come from various minority populations.
  • Genome-Wide Association Studies to Identify Genetic Components Related to Heart, Lung, and Blood Disorders: To identify genetic variants related to heart, lung, and blood disorders and their risk factors using existing population, family, and clinical studies. Several of the asthma-related projects have strong minority representation in the study populations

The Institute also supports investigator-initiated projects on the etiology and pathophysiology of asthma. They include a study to identify positional gene candidates for airway hyperresponsiveness and compare their association with asthma between two asthmatic groups: a white population on Tangier Island, VA, and a black population from Barbados; a study to establish the link between specific genotypic variants and phenotypic markers, and to elucidate the immunological pathways that contribute to asthma severity in blacks; and a case-controlled study to identify genetic determinants of asthma risk among populations of African ancestry by performing genome-wide association studies and gene–gene and gene–environment interaction studies.

Latinos carry a disproportionate burden of asthma. Yet few investigators studying the genetics of asthma have focused on them, partly due to the complexity of the Latino gene pool. One study, however, is developing and testing new methods to correct for population stratification due to racial admixture, a key problem confounding genetic studies in the Latino population. The project focuses on data from the NHLBI-supported Genetics of Asthma in Latino Americans to assess population stratification.

Other projects that focus on Hispanic populations include one that uses genomic screening to search for the genetic basis of asthma in a homogeneous Hispanic population in Costa Rica and another that involves a population-based case control association study to examine the influence of genetic and environmental factors on the development and severity of asthma in Puerto Rican children.

Occupational and environmental factors are known to trigger asthma symptoms. An investigator-initiated study is focusing on understanding the mechanisms by which occupational or environmental factors trigger the onset of asthma among low-income, urban blacks and Hispanics. Another study is examining the association of early exposure to endotoxin (which appears to promote the development of the immune system), nitrogen dioxide, and aeroallergens (which trigger asthma exacerbations); obesity; physical inactivity; and environmental tobacco smoke on the prevalence, persistence, and incidence of asthma in black and Hispanic children enrolled in inner-city Head Start programs.

Circadian change in airway function is an important aspect of asthma, as more than 70 percent of deaths and 80 percent of respiratory arrests occur during sleep. Focusing on nocturnal asthma, researchers are investigating the mechanisms that cause the changes in airway function that lead to exacerbation of symptoms; minority populations comprise 36 percent of the study population.

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Treatment and Control

The Institute has initiated research to identify optimal drug strategies for treatment and management of asthma. Because the burden of asthma disproportionately affects minority children, it is important for them to be well represented in clinical trials.

  • ACRN-Phase II (see Chapter 11): To establish an interactive network of asthma clinical research groups to conduct studies of new therapies for asthma and disseminate findings to the practicing community. Overall, 30 percent of the participants are from minority populations.
  • CARE (see Chapter 11): To establish a network of pediatric clinical care centers to determine optimal treatment and management strategies for children with asthma. The studies considered by the network will attempt to customize therapy based on specific asthma phenotypes and genotypes; minorities comprise 30 percent of the population.
  • Centers for Reducing Asthma Disparities (see Chapter 9): To support partnerships between minority-serving institutions and research-intensive institutions to conduct studies on causes of and corrections for disparities in asthma among racial/ethnic and low SES populations. Reciprocal training is encouraged to ensure culturally sensitive projects and enhance research capabilities.

The Institute is also supporting investigator-initiated studies focusing on finding effective treatment for various populations. One study is examining the effect of steroids on enhanced alpha-adrenergic vascular responsiveness in asthma; 77 percent of the participants are minority. Another study is using preexisting, well-characterized cohorts of patients with asthma to identify genetic variants that can predict therapeutic response to asthma drugs. Scientists are interested in the influence of race/ethnicity on the genetic factors associated with asthma therapeutic responses.

Translational Activities

Ensuring full use of modern asthma treatment strategies is an important goal of the NHLBI. The Institute is supporting an investigator-initiated study to determine the effectiveness of an intervention that is removing barriers to preventive care to improve asthma management and lower asthma morbidity. Scientists are using a Breathmobile to deliver asthma screening to black children attending Head Start programs and a special consultation service to communicate directly with the parents about asthma management. Another study among low-income, inner-city children with asthma attending preschool is testing a bilingual intervention program to improve asthma management; 60 percent of the participants are Hispanic and 40 percent are black.

Additional studies to improve asthma management among minority groups include a study to test whether individualized interventions will improve asthma management in a black and Hispanic population. Another study seeks to improve asthma management by teaching children with asthma to recognize symptoms of the presence of airflow obstruction; 42 percent of the participants are black and 6 percent are Hispanic.

Two randomized controlled trials are being conducted among patients recruited at the time of an emergency department visit for asthma exacerbation. One study is testing an intervention to enhance knowledge, self-efficacy, and asthma-related social support; 40 percent of the patients are minorities. The other study focuses on young black children recruited at the time of an emergency department visit for asthma exacerbation. Investigators are testing the effectiveness of an intervention strategy that includes case management, telephone contacts, and a monetary incentive to increase follow-up visits to primary care providers.

Three studies are evaluating the benefits of working with public school systems to improve adherence to asthma management. In Birmingham, Alabama, scientists are evaluating the impact of school-based supervised asthma therapy on asthma exacerbations in a predominately black population with moderate-to-severe asthma. In New York, they are testing the ability of an intervention that includes in-school intensive asthma education to 9th- and 10th-grade students who have persistent asthma and intensive asthma education for their community physicians to improve asthma morbidity; 90 percent of the participants are black. In Detroit, investigators are developing and evaluating an Internet-based self-management program for black teens with asthma.

Chronic environmental tobacco smoke exposure, particularly from parental smoking, is associated with more severe asthma, increased incidence of emergency department visits, life-threatening attacks, and prolonged time to recovery from asthma exacerbation requiring hospitalization. A study is being conducted to evaluate an intervention tailored to parental stage of change regarding smoking practice, to reduce asthma crisis care used by children with persistent asthma.

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Education

The Institute has developed easy-to-read materials on asthma treatment and control directed to English and Spanish audiences with low literacy.

  • Facts About Controlling Your Asthma
  • El Asma: Cómo Controlar Esta Enfermedad (Facts About Controlling Your Asthma)

Chronic Obstructive Pulmonary Disease

COPD is a disease in which the lungs are damaged, making breathing difficult. It is responsible for more than 500,000 hospitalizations and 100,000 deaths in the United States each year. The Institute has established a research network to determine effective disease management approaches for individuals with moderate-to-severe COPD.

  • COPD Clinical Research Network (see Chapter 11): To perform collaborative, therapeutic interventional trials of medications, devices, and disease management strategies in individuals with moderate-to-severe COPD. In addition to evaluating treatment efficacy, network studies may include examinations of genetic factors, biomarkers, or genomic/proteomic profiles that may identify patients who are more or less likely to benefit from various treatments.

The NHLBI has recently begun a large, investigator-initiated study of genetic factors that determine the risk of developing COPD or that influence the type and extent of damage done to the body by the disease. The COPDGene™ study will enroll approximately 3,500 blacks with a substantial history of cigarette smoking, obtain extensive baseline clinical and phenotypic data regarding the individuals, and compare the severity and character of COPD in the subjects to analyses of their DNA. Genomewide genetic assays will be performed on a substantial fraction of this cohort.

Although COPD is less common among blacks than among whites, it is nevertheless the seventh leading cause of death among blacks. Any disparity, whether higher or lower in the minority group, may reflect racial differences in the biology of the disease that would require use of different treatments or drugs for optimal disease management. If the genes found to be determinants of COPD risk differ in blacks and whites, this will provide clues to how the roles of specific pathogenetic pathways of COPD differ among races.

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Sarcoidosis

Sarcoidosis is an inflammatory disease of unknown etiology characterized by persistent granulomas with damage to surrounding tissue. The Institute has initiated a program to determine the immunopathogenesis of granulomatous inflammation found in sarcoidosis, including the role of predisposing factors, the immune components involved in the formation of granulomas, and the defective regulatory immune response.

In the United States, sarcoidosis often occurs more frequently and with more severity in blacks than in whites. This may reflect the intensity of the noncaseating granuloma, the hallmark of sarcoidosis, in affected tissue. A twofold greater density of granuloma in bronchiolar lung biopsies was recently found in black patients, which correlated as a measure of disease severity.

Investigator-initiated studies on the causes of sarcoidosis include a study to identify genes linked to sarcoidosis susceptibility in blacks and to determine if hereditary susceptibility predisposes blacks to sarcoidosis, and a project to elucidate the mechanisms involved in the immunologic and inflammatory processes that ultimately lead to end-stage fibrosis in progressive pulmonary sarcoidosis; many of the participants are black.

A new project funded in FY 2008 will support mentored research to investigate selected genetic and nongenetic potential risk factors for sarcoidosis. This project will be conducted within the Black Women's Health Study.

Sleep Disorders

Sleep-disordered breathing (SDB), a condition characterized by repetitive interruption in breathing, is a common disorder that disproportionately affects blacks. It is associated with an increased risk of CVD, including hypertension and stroke, and is particularly prevalent in patients with heart failure. Ongoing programs are assessing the interrelationship between sleep disorders and heart failure and the mechanisms leading to cardiovascular stress when the two intersect.

The Institute also supports a spectrum of investigator-initiated projects to elucidate cardiovascular and other health consequences of SDB, sleep deprivation, and shift work in various community settings. Characterization of how SDB occurs within family groups is helping to identify potential genetic risk factors that may allow early identification and treatment of high-risk individuals. A community-based study of sleep in Hispanics is assessing the prevalence and awareness of sleep disorders.

The Institute supports research related to the consequences of short sleep or sleep disturbances.

  • Mechanisms Linking Short Sleep Duration and Risk of Obesity or Overweight: To examine cause-and-effect relationships and mechanisms that may explain the association between short sleep duration and increased risk of obesity or overweight due to altered metabolism, appetite, or inflammation. Minority participation ranges from 29 percent blacks to a Chinese twin cohort.
  • Inter-Relationships of Sleep, Fatigue, and HIV/AIDS: To elucidate the etiology of sleep disturbances and fatigue associated with HIV/AIDS. Most of the participants are black.

Treatment and Control

The NHLBI has initiated a clinical trial to determine whether adenotonsillectomy is an effective treatment for SDB in children.

  • Randomized Controlled Study of Adenotonsillectomy for Childhood Sleep Apnea (see Chapter 9): To assess the efficacy of adenotonsillectomy as a treatment for SDB in children aged 5 to 9 years; 50 percent of the participants are from various minority and ethnic populations.

Education

The NHLBI published Your Guide to Healthy Sleep, which provides the latest information about sleep apnea and other sleep disorders, including insomnia, restless legs syndrome, and narcolepsy.

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HIV-Related Lung Diseases

HIV infection disproportionately affects minority populations in the United States and due to multidrug antiretroviral therapy, has become a chronic condition for many patients. Among them, HIV-associated lung complications are frequent causes of illness and death. But the long-term consequences of HIV infection and HIV-associated lung infections and complications are unknown. Little is known about drug-resistant Pneumocystis, the prevalence and pathogenesis of HIV-associated COPD, HIV-associated pulmonary hypertension, and immune reconstitution syndromes. In developing countries where millions of people are HIV-infected, many have serious or fatal lung complications including TB and bacterial pneumonias that have never been well characterized.

Etiology and Pathophysiology

In addition to supporting investigator-initiated research on the etiology and pathogenesis of HIV-associated lung diseases, the Institute has initiated research to understand their causes and impact and to identify potential therapeutic targets and preventive strategies.

  • The Mechanisms of HIV-Related Pulmonary Complications: To encourage innovative research on the roles of co-infections, immune factors, and genetic predisposition in the pathogenesis of HIV-related pulmonary diseases.
  • Longitudinal Studies of HIV-Associated Lung Infections and Complications: To accelerate research on lung complications associated with HIV-infection by characterizing lung infections, other HIV-associated lung complications, and their consequences in longitudinal studies in existing HIV-infected cohorts and other established groups of patients who are HIV-infected. Expected minority enrollments at the U.S. sites range from approximately 40 to greater than 80 percent, depending on the center.

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Tuberculosis

TB is a common and often deadly infectious disease caused by the bacteria Mycobacterium tuberculosis. In the United States, it is estimated that 10 to 15 million people are infected with the TB bacteria, and 22,000 new cases of TB occur each year.

Etiology and Pathogenesis

The Institute supports investigator-initiated research that includes characterizing genes associated with TB susceptibility, investigating host lung defenses, including immune responses to infection and studying the impact of TB on HIV disease.

Treatment and Control

The NHLBI supports a number of investigator-initiated studies focused on understanding the relationship between the immune system and TB. Most of the studies are being conducted among patients from minority populations. Included among them are studies to compare susceptibility to TB in populations in Mexico and Peru; examine the role of interferon-gamma in the pathogenesis of TB among Hispanics with and without HIV; identify and characterize host factors that predispose Asians to develop TB; and determine the effectiveness of adding aerosolized interferon-gamma to the usual treatment regimen for advanced TB in predominately minority populations in the United States and South Africa.

The NHLBI also supports research to improve TB control among minority populations. One project is evaluating educational strategies to improve adherence to medication regimens and regular clinic visits among Hispanic adolescents infected with TB. Another study, located in the Harlem community of New York City, is testing a new strategy to promote adherence to therapy among inner-city patients who have TB. Both programs are outgrowths of behavioral research programs begun by the Institute in 1995.

A third program, directed toward public health workers, could affect the health of minority populations, where TB rates are disproportionately high. Scientists are evaluating the effectiveness of a new TB contact priority model for investigating contacts of persons who have infectious TB. An effective model could enhance contact investigations and provide more efficient TB disease control.

Education

Building on the foundation laid by the Tuberculosis Academic Award program, the NHLBI is supporting a consortium of five TB curriculum centers:

  • TB Curriculum Coordinating Center: To strengthen, expand, and increase access to the best ongoing educational and training opportunities in TB for medical, nursing, and allied health schools, especially those that provide primary care to communities where TB is endemic and the population is at high risk of developing TB.

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Blood Diseases

The NHLBI supports basic and clinical research on SCD and Cooley's anemia with the goal of curing the disorders and improving patient care.

Sickle Cell Disease

Basic Research

SCD is an inherited blood disorder that produces chronic anemia, periodic episodes of pain, and end organ damage. It affects about 1 in 500 blacks and 1 in 1,000 Hispanics. Since 1972, the NHLBI has supported an extensive research program to improve understanding of the pathophysiology of SCD, identify better approaches for its diagnosis and treatment, and prevent complications.

Basic and translational research currently focuses on genetic influences on disease manifestations, regulation of hemoglobin synthesis, discovery of drugs to increase fetal hemoglobin production, transplantation of blood-forming stem cells, gene therapy, and development of animal models for preclinical studies. The NHLBI supports this research through Institute-initiated and investigator-initiated projects.

  • BTRP (see Chapter 9): To encourage fundamental investigations and their translation into initial studies in humans, as well as community translation to promote evidence-based clinical practice. SCD Scholars programs for the career development of young investigators and Summer-for-Sickle-Cell-Science programs for research training and mentoring of high-school students also will be supported as part of a larger effort by the Institute to prepare the next generation of scientists to advance the field of SCD research. The BTRP was reconfigured from the NHLBI Comprehensive Sickle Cell Centers (CSCC) program.
  • Pulmonary Complications of Sickle Cell Disease: To stimulate collaborative translational research on the pulmonary complications of SCD. Researchers in hematology and pulmonary science, using a combination of basic and clinical approaches, are investigating the major known pulmonary complications of SCD due to acute chest syndrome, pulmonary hypertension, and oxyhemoglobin desaturation.

Two trans-NHLBI initiatives support research in SCD:

  • Genome-Wide Association Studies to Identify Genetic Components Related to Heart, Lung, and Blood Disorders (see page 142): To investigate common genes involved in subphenotypes of SCD and centenarians. Scientists seek to identify genetic associations with specific clinical features in the two populations and subsequently compare the two datasets for differences and similarities. Research results could lead to improved treatment for SCD and increase our understanding of the genetic components that enhance healthy aging.
  • Ancillary Studies in Clinical Trials: To conduct time-sensitive ancillary studies in conjunction with ongoing Phase II-III clinical trials or network clinical trials related to heart, lung, and blood diseases and sleep disorders. One study seeks to identify genetic variations underlying Rh antigenic diversity in patients who have SCD. Research findings will be used to develop high throughput microchips to screen for matching donors and recipients prior to blood transfusion. Knowledge of the genetic basis for compatibility between donors and patients who have SCD for transfusion could contribute to preventing alloimmunization and improve care for patients who have SCD. Another study employs proteomic approaches to identify biomarkers of early cerebral ischemia in children who have SCD. Identifying such circulating biomarkers could allow earlier therapeutic intervention in these children.

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Clinical Research

The NHLBI is committed to finding improved treatments and ultimately a cure for SCD and other hemoglobinopathies. Institute-initiated studies have begun to yield therapies that will alleviate the symptoms of sickle cell anemia and procedures that should ultimately provide a cure.

  • BABY HUG (see Chapter 11): To assess the effectiveness of hydroxyurea in preventing onset of chronic organ damage in young black children who have sickle cell anemia. At baseline, the trial has demonstrated that the spleens and kidneys of 1-year-old children are already damaged.
  • SWITCH (see Chapter 9): To determine whether hydroxyurea and phlebotomy can maintain an acceptable stroke recurrence rate and significantly reduce hepatic iron burden compared with transfusion plus chelation in black children who have had overt stroke.
  • Sickle Cell Disease Clinical Research Network (see Chapter 11): To conduct Phase III randomized controlled clinical trials to test the efficacy and effectiveness of new therapies to treat and prevent complications of SCD and, when appropriate, thalassemia.
  • Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension (see Chapter 11): To test the effects of 16 weeks of chronic sildenafil therapy on exercise endurance and pulmonary artery pressure in patients aged 14 years or older with pulmonary hypertension and SCD. The NHLBI Intramural Vascular Medicine Branch is participating as one of the nine clinical centers in this trial.
  • Clinical Trials Consortium: To complete two Phase II trials that had been initiated by the CSCC program: CHAMPS, which examines the effectiveness of hydroxyurea and magnesium pidolate alone and in combination in subjects with hemoglobin SCD, and the Neuropsych II Study, a pilot study that compares the neuropsychological outcomes of adult patients who receive chronic transfusions compared with patients who are not transfused.
  • The Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me): To develop, validate, and disseminate a sickle cell-specific quality-of-life measurement tool that is a partner with and complementary to the NIH Roadmap Patient-Reported Outcomes Measurement Information System (PROMIS). ASCQ-Me will be publicly available to researchers who plan to assess health-related quality of life in clinical trials, and studies comparing effectiveness of different therapies.

The NHLBI supports several transplant-related clinical studies that seek to reach minority populations.

  • Blood and Marrow Transplant Clinical Trials Network (BMT CTN) (see Chapter 11): In collaboration with the NCI, to perform clinical trials to advance hematopoietic stem cell transplantation. To reach minority populations, the Network supports bilingual transplant center personnel and provides public Web pages and educational materials. In addition, the Network is working with the National Marrow Donor Program to develop strategies and implement procedures to enhance enrollment of patients from minority groups.

A new clinical trial of unrelated donor marrow and umbilical cord blood transplantation for severe SCD is being supported through the BMT CTN and the Sickle Cell Disease Clinical Research Network. The Sickle Cell Unrelated Transplant Trial is the first Phase II study to assess the promise of this therapy as a curative option for patients who are severely affected by SCD.

The NIH Hydroxyurea Treatment for SCD Consensus Conference, sponsored by the NIH Office of Medical Applications of Research and the NHLBI, along with other NIH and HHS components was held in February 2008. This conference assessed the available scientific evidence and concluded that hydroxyurea treatment for patients who have sickle cell anemia is underutilized and should be increased in adolescents and adults. Research has shown that patients who have SCD and are taking hydroxyurea experience fewer pain crises and hospital admissions. The conference panel advocated increased use of the drug with appropriate monitoring, and continuing follow-up of children in ongoing clinical trials.

To build capacity for clinical research, the NHLBI is funding the Clinical Hematology Research Career Development Program, which supports the early career development of clinical researchers who are expected to become independent investigators and assume academic leadership roles in nonmalignant clinical hematology.

Recommitment to Sickle Cell Disease Research

In March 2008, after a rigorous program assessment, extensive public input, and advice from the NHLBAC, the NHLBI announced a comprehensive and innovative restructuring of its research SCD program. As a result, the NHLBI is moving forward with the following innovations to its SCD portfolio:

  • Basic science: Support for basic research will be expanded through funding of investigator-initiated grant applications and through NHLBI-initiated RFAs focused on the pathophysiology of SCD, the biology of pain in SCD, fetal hemoglobin switching, and genetic modifiers of disease expression and progression.
  • Translational and clinical research: the Institute reconfigured the CSCC program into a BTRP with dedicated training components.
  • Participation in clinical research: The scope of clinical research trials will be broadened to allow a greater number of people with SCD to participate in NIH-sponsored clinical research trials.
  • Translation and dissemination to the community: In partnership with the Sickle Cell Disease Association of America and other patient advocacy groups and professional organizations, the NHLBI will develop evidence-based guidelines for the care of people with SCD across the life-span that can be used by health care practitioners throughout the world.

Education

The NHLBI has developed a number of publications on SCD that target minorities:

  • Datos Sobre La Anemia Falciforme (Facts About Sickle Cell Anemia)
  • Fact Sheet: Hydroxyurea in Pediatric Patients With Sickle Cell Disease
  • Facts About Sickle Cell Anemia
  • Patient Fact Sheet: The Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH)
  • Management and Therapy of Sickle Cell Disease.

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Cooley's Anemia

Cooley's anemia is an inherited disorder of red blood cells that affects primarily people of African, Asiatic Indian, Chinese, Mediterranean, and Southeast Asian origin. In 2000, the Institute initiated a program to establish a network of clinical research centers to evaluate new therapeutic agents.

  • Thalassemia (Cooley's anemia) Clinical Research Network (see Chapter 11): To establish a group of clinical centers to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones.

The NHLBI supports research efforts that include developing oral chelators to remove iron overload caused by repetitive transfusion therapy, testing drugs to enhance fetal hemoglobin production, and examining hematopoetic transplantation and gene therapy approaches to cure the disease. A registry with samples has been established to foster genomic and proteomic studies. International collaborations have also been initiated.

In 2006, the Institute established the NHLBI Clinical Hematology Research Career Development Program to support career development of clinical researchers in nonmalignant clinical hematology including Cooley's anemia.

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