« Factbook Table of Contents

2. Program Overview

• Division of Heart and Vascular Diseases
• Division of Lung Diseases
• Division of Blood Diseases and Resources
• Division of Epidemiology and Clinical Applications
• National Center on Sleep Disorders Research
• Division of Intramural Research

The National Heart Institute (NHI) was established in 1948 through the National Heart Act with a mission to support research and training in the prevention, diagnosis, and treatment of cardiovascular diseases (CVD). Twenty-four years later, through section 413 of the National Heart, Blood Vessel, Lung, and Blood Act (P.L. 92-423), Congress mandated the Institute to expand and coordinate its activities in an accelerated attack against heart, blood vessel, lung, and blood diseases. The renamed National Heart, Lung, and Blood Institute (NHLBI) expanded its scientific areas of interest and intensified its efforts related to research on diseases within its purview. Over the years, these areas of interest have grown to encompass genetic research, sleep disorders, and the Women's Health Initiative (WHI).

The mission of the NHLBI is to provide leadership for a national program in diseases of the heart, blood vessels, lung, and blood; sleep disorders; and blood resources management. The Institute:

• Plans, conducts, fosters, and supports an integrated and coordinated program of basic research, clinical investigations and trials, observational studies, and demonstration and education projects related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases, and sleep disorders conducted in its own laboratories and by other scientific institutions and individuals supported by research grants and contracts.
• Plans and directs research in development and evaluation of interventions and devices related to the prevention of heart, lung, and blood diseases and sleep disorders and the treatment and rehabilitation of patients who suffer from them.
• Conducts research on the clinical use of blood and all aspects of the management of blood resources.
• Supports career training and development of new and established researchers in fundamental sciences and clinical disciplines to enable them to conduct basic and clinical research related to heart, blood vessel, lung, and blood diseases; sleep disorders; and blood resources through individual and institutional research training awards and career development awards.
• Coordinates relevant activities with other research institutes and all Federal health programs in the above areas, including the causes of stroke.
• Conducts educational activities, including development and dissemination of materials for health professionals and the public in the above areas, with emphasis on prevention.
• Maintains continuing relationships with institutions and professional associations, and with international, national, state, and local officials, as well as voluntary agencies and organizations working in the above areas.
• Oversees management of the WHI.

Each year, the NHLBI assesses progress in the scientific areas for which it is responsible and updates its goals and objectives. As new opportunities are identified, the Institute expands and revises its areas of interest. Throughout the process, the approach used by the Institute is an orderly sequence of research activities that includes:

• Acquisition of knowledge
• Evaluation of knowledge
• Application of knowledge
• Dissemination of knowledge.

As shown on page 10, the programs of the NHLBI are implemented through five extramural program units: the Division of Heart and Vascular Diseases (DHVD), the Division of Lung Diseases (DLD), the Division of Blood Diseases and Resources (DBDR), the Division of Epidemiology and Clinical Applications (DECA), and the National Center on Sleep Disorders Research (NCSDR); and one intramural unit, the Division of Intramural Research (DIR). Although the NHLBI has primary responsibility for the WHI, it is run by a consortium that includes the National Cancer Institute (NCI), the National Institute on Aging (NIA), and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The Divisions and the Center pursue their own scientific missions but cooperate in areas of common interest. The extramural Divisions and the NCSDR use a variety of funding mechanisms, such as research grants, cooperative agreements, program project grants, Small Business Innovation Research (SBIR) grants, Small Business Technology Transfer grants, Specialized Centers of Research (SCOR) and Specialized Centers of Clinically Oriented Research (SCCOR) grants, comprehensive center grants, contracts, and research training and career development programs. Descriptions of the Division and Center programs, as well as the WHI, follow.

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Division of Heart and Vascular Diseases

The DHVD plans and directs a coordinated research program on the causes of heart and vascular diseases and on their prevention, diagnosis, and treatment. Fundamental biomedical research, including cutting-edge areas such as genomics, proteomics, nanotechnology, cell-based therapeutics, and gene therapy, is emphasized. Multidisciplinary programs are supported to advance basic knowledge of disease and to generate the most effective methods of clinical management and prevention. Clinical trials are an important part of the research program; they provide an opportunity to test and apply promising preventive or therapeutic measures.

The Division is organized into three major research programs:

• Heart Research Program
• Vascular Research Program
• Clinical and Molecular Medicine Program

and the Research Training and Special Programs Scientific Research Group (SRG).

Heart Research Program

The Heart Research Program supports basic and clinical research in cardiac diseases, from embryonic life through adulthood. Targeted areas include heart development, cardiac disorders, inflammation and infectious disorders of the heart, heart transplantation, and myocardial preservation. Individual studies focus on normal and abnormal cardiac development, diabetic cardiomyopathy, genenutrient interactions in the pathogenesis of congenital heart defects, pathogenesis of heart failure, electrical remodeling, and various aspects of human immunodeficiency virus (HIV) infection as it relates to the heart. SCCORs support clinical collaborative research in (1) cardiac dysfunction and disease and (2) pediatric heart development and disease. The Program comprises the two SRGs described below.

Heart Development, Function, and Failure SRG

The Heart Development, Function, and Failure SRG oversees a research program in heart development, cardiac function, and heart failure. It includes basic studies examining normal functional and structural development of the heart and major blood vessels, as well as the genetic, molecular, environmental, and mechanical etiology of congenital cardiovascular malformations. Clinical research networks are used to evaluate new treatment methods and management strategies for congenital malformations and acquired pediatric heart disease.

Research on cardiac function and failure focuses on fundamental mechanisms associated with the structure, function, mechanics, and bioenergetics of normal and diseased myocardium; the role of contractile proteins in the cardiovascular system; and causes of cardiac hypertrophy and the subsequent transition from hypertrophy to heart failure. Individual projects include molecular, cellular, and physiological studies of diabetic cardiomyopathy; pathogenesis of heart failure, with emphasis on apoptosis (programmed cell death), myocyte division and growth, and cell transplantation; and studies to identify modifiers of gene defects leading to hypertrophic cardiomyopathy and heart failure.

Arrhythmias, Ischemia, and Sudden Cardiac Death SRG

The Arrhythmias, Ischemia, and Sudden Cardiac Death SRG oversees a research program on cardiac arrhythmias that focuses on elucidating the mechanisms involved in control of cardiac electrical activity; determining the contribution of cardiac membrane biophysics, membrane structure and organization, ion pumps and channels, and transport and gap junction proteins to electrogenesis; and understanding the long-term control of cardiovascular function as it relates to the onset or maintenance of arrhythmias. Investigators are seeking knowledge that will lead to the development of new approaches to diagnosis, treatment, and prevention of arrhythmias.

The SRG also oversees a research program on the etiology and pathophysiology of ischemic heart disease and its consequences and control and treatment of cardiac electrical activity, rhythm, and rate, especially as they relate to sudden cardiac death. Researchers are seeking ways to improve the diagnosis and treatment of myocardial ischemia. Special attention is directed toward understanding the pathophysiology of ischemic heart disease in blacks, a population that is disproportionately affected by the disorder.

Vascular Biology Research Program

The Vascular Biology Research Program supports research in atherosclerosis, hypertension, basic vascular biology, and gene therapy for prevention and treatment of vascular diseases. Other targeted areas focus on the etiology, pathogenesis, and treatment of excess CVD in diabetes mellitus and cardiovascular complications of HIV/AIDS. SCORs support collaborative studies on molecular medicine and atherosclerosis and the molecular genetics of hypertension. The Program comprises the two SRGs described below.

Atherosclerosis SRG

The Atherosclerosis SRG oversees a comprehensive research program on the etiology, pathogenesis, diagnosis, prevention, and treatment of atherosclerosis. Areas of emphasis include pathobiology and genetics of the vasculature; vascular growth and angiogenesis; interactions of the vascular wall with systemic and humoral factors promoting atherogenesis; and lesion progression, complication, and regression. Individual studies focus on characterization of vulnerable atherosclerotic plaque, pathogenesis of abdominal aortic aneurysms, role of homocysteinemia in atherosclerosis, mechanisms of atherosclerosis in various vascular beds, and research on atherosclerotic lesions. Additional projects target pathobiological determinants of atherosclerosis, cardiovascular complications of diabetes mellitus, vessel-wall calcification, the role of infectious agents in atherosclerosis, immunobiology of the vessel wall, obesity-associated CVD, exercise physiology, peripheral artery disease (PAD), and effect of protease inhibitors on atherosclerosis development in HIV infection. Of special interest is understanding atherosclerosis risk among minorities.

Hypertension SRG

The Hypertension SRG directs a research program to identify and characterize genes and their corresponding phenotypes involved with hypertension; elucidate regulation mechanisms associated with blood pressure control; clarify functional control of the cerebrovasculature; and identify causative factors of essential hypertension and rare forms of high blood pressure. It also seeks to determine the mechanisms by which high blood pressure increases the risk of, or occurs concomitantly with, other diseases such as kidney failure, stroke, metabolic syndrome X, obesity, diabetes mellitus, atherosclerosis, preeclampsia, and left ventricular hypertrophy. Further, it fosters studies to develop preventive strategies and interventions for hypertension, understand the biological underpinnings of salt sensitivity and the basis of target-organ damage in hypertension, and identify neurological mechanisms responsible for long-term control of blood pressure and functional neurological changes that result in essential hypertension. Attention is directed to eliminating health disparities among minorities and between men and women.

Clinical and Molecular Medicine Program

The Clinical and Molecular Medicine Program supports clinical, basic, engineering, and quantitative research on CVD and health. Areas of interest include genetics, genomics, and proteomics; engineering theory and practice applied to cardiovascular biology and medicine; informatics and simulation; computational systems; and cohort, case-control, and randomized clinical trials. Projects focus on heart failure, revascularization, renal stenting, diabetes management, outcome improvement in resuscitation, reduction in cardiovascular health disparities, minority and women's health, and the implantable artificial heart. The program comprises the two SRGs described below.

Cardiovascular Medicine SRG

The Cardiovascular Medicine SRG directs a research program on CVD in adult and pediatric patients. It examines the role of lipid interventions, nutrition, and exercise in preventing heart disease. Areas of emphasis include development of treatments or new applications of existing medical and surgical strategies for acute and chronic ischemic heart disease; dietary and medical management of dyslipidemia; quantitative measurement of atherosclerosis; diagnosis and management of arrhythmias; resuscitation; cardiomyopathies of different etiologies (e.g., ischemic, valvular, metabolic, HIV-related, other infectious); congenital malformations; peripheral vascular disease; restenosis after revascularization procedures; cardiovascular applications of radiotherapy; and cardiovascular dysfunction in long-term pediatric cancer survivors.

Bioengineering and Genomic Applications SRG

The Bioengineering and Genomic Applications SRG directs an interdisciplinary research program that applies engineering theory and practice to increase knowledge at the genetic, molecular, cellular, tissue, and organ level and examines materials, processes, and devices for the cardiovascular system. Individual projects focus on innovative ventricular assist systems, implantable total artificial hearts, genetically enhanced cardiovascular implants, nanotechnology, magnetic resonance angiography, physical stress and strain, micromechanics, self-assembly, mathematical models, simulation and systems, imaging, biomaterials, tissue engineering, and therapeutic devices.

Division of Lung Diseases

The DLD plans and directs a coordinated research program on the causes and progression of lung diseases and on their prevention, diagnosis, and treatment. Areas of interest include the biology and function of the respiratory system, fundamental mechanisms associated with specific pulmonary disorders, and development of new treatment strategies for patients. SCORs support collaborative studies on cellular and molecular mechanisms of asthma, airway biology and pathogenesis of CF, the pathobiology of lung development, and the pathobiology of fibrotic lung disease; a SCCOR supports collaborative translational research in acute lung injury. Demonstration and education projects to transfer basic research and clinical findings to health care professionals and patients, as well as training and career development programs for individuals interested in furthering their professional abilities in lung diseases research, also are important activities.

The Division is organized into two major research programs:

• Airway Biology and Disease Program
• Lung Biology and Disease Program.

Airway Biology and Disease Program

The Airway Biology and Disease Program supports basic and clinical research, education, and training related to asthma, COPD, CF, control of breathing, bronchiolitis, respiratory neurobiology, sleep, and other adult airway diseases. It comprises the four research SRGs described below and a Training and Special Programs SRG, which manages training and career development in lung diseases research for individuals at all stages of their professional development.

Asthma SRG

The Asthma SRG oversees a broad research program in asthma. Basic research focuses on elucidating the etiology and pathophysiology of the disease. Studies include elucidating the cellular and molecular mechanisms associated with development, exacerbation, and persistence of asthma and the effect of the environment on them; identifying susceptibility genes that influence development, progression, outcome, and response to treatment in different racial groups; determining the differences between the pathophysiology of severe asthma and mild-to-moderate asthma; and investigating the role of the immune system, its function in early life, and its influence on asthma development.

Clinical research focuses on improving asthma management and reducing health disparities in asthma that exist between whites and other ethnic groups, as well as economically disadvantaged populations. Two asthma networks have been established to assess new treatment strategies and ensure rapid dissemination of research findings to health care professionals. The Division has established cooperative partnerships between minority-serving institutions and research-intensive institutions to examine factors that contribute to health disparities and to develop strategies for their elimination. The purpose of the partnerships is to conduct collaborative research on asthma disparities and provide reciprocal training experiences to enhance research opportunities and capabilities and enrich the cultural sensitivity at both institutions.

Chronic Obstructive Pulmonary Disease/Environment SRG

The COPD/Environment SRG oversees research on the underlying causes of COPD and improving its treatment and management. Studies include examining the role of inflammation in the pathogenesis of COPD; searching for genes that may make some individuals more susceptible to the development of the disorder; identifying and characterizing biomarkers of COPD presence, severity, and exacerbation; evaluating treatment strategies; and applying gene therapy to correct the defective gene or to introduce the functional gene for alpha-1 antitrypsin in deficient individuals with familial emphysema.

A clinical research network has been established to conduct clinical trials of promising therapies for COPD that may reduce the frequency and severity of disease exacerbation. Additionally, a program was initiated to provide researchers with lung tissue specimens that were removed for medical reasons and are not needed for diagnostic purposes.

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Cystic Fibrosis SRG

The CF SRG oversees basic and clinical research related to the origins and control of infections and inflammatory and immune responses in the lungs of CF patients, loss of CF transmembrane conductance regulation on development of CF, effects of other genes on its manifestation, and genetic and metabolic defects underlying pulmonary complications associated with CF. Developing new genetic, pharmacologic, and nonpharmacologic (e.g., gene transfer) treatments also is an area of emphasis.

Sleep and Neurobiology SRG

The Sleep and Neurobiology SRG oversees sleep research on sleep and circadian neurobiology, sleep regulation, health consequences, and treatment of sleep disorders, sleep disordered breathing, and ventilatory control.

Lung Biology and Disease Program

The Lung Biology and Disease Program supports research, education, and training programs in lung cell and vascular biology; developmental biology and pediatric lung diseases; acute lung injury and critical care medicine; interstitial lung diseases, including pulmonary fibrosis; and AIDS and TB. It comprises the five research SRGs described below and a Training and Special Programs SRG that manages training and career development in lung diseases research for individuals at all stages of their professional development.

Acquired Immunodeficiency Syndrome/Tuberculosis SRG

The AIDS/TB SRG oversees a research program on the basic pathogenetic mechanisms involved in HIV-related lung disorders, especially TB–HIV dual infection and animal and mathematical models to gain information that may lead to new treatment strategies. Many of the studies employ genetic, molecular, and cellular approaches. Additional areas of interest include cardiopulmonary complications of HIV infection in infants, children, and adults; pathobiology of TB and Pneumocystis carinii and basic cell biology of pulmonary manifestation of AIDS; lung-specific drug delivery systems for enhanced TB treatment; behavioral interventions for control of TB; and educational programs to improve training in TB.

Acute Lung Injury/Critical Care SRG

The Acute Lung Injury/Critical Care SRG oversees research on the etiology and molecular and cellular pathogenesis of acute respiratory distress syndrome (ARDS). It supports an ARDS clinical network to evaluate therapeutic strategies such as pulmonary artery catheterization, fluid management, and use of anti-inflammatory agents, including corticosteroids, in patients with the disorder and those at risk. Other areas of focus include basic studies on the pathogenesis of acute respiratory syndrome (SARS) in the lung and studies to improve the diagnosis, treatment, and outcome of critically ill patients with lung injury.

Developmental Biology and Pediatrics SRG

The Developmental Biology and Pediatrics SRG oversees research on normal lung development and on factors that may contribute to its abnormal development such as prenatal and postnatal infections and reactive inflammation. Additional areas of emphasis include understanding the regulation of lung alveoli development in order to design new treatments for lung diseases, creating a molecular profile of bronchopulmonary dysplasia to advance understanding of the condition and lead to effective clinical intervention, evaluating the safety and efficacy of nitric oxide in preventing and treating chronic lung disease in newborn infants, and evaluating the efficacy of nasal continuous positive airway pressure compared with conventional ventilation, with and without surfactant, in the management of premature newborns.

Immunology/Fibrosis SRG

The Immunology/Fibrosis SRG oversees research on interstitial lung diseases, such as sarcoidosis, idiopathic pulmonary fibrosis (IPF), and lymphangioleiomyomatosis (LAM), which are characterized by chronic inflammation and progressive fibrosis of the lung alveolar walls and surrounding tissue. Specific projects focus on elucidating the cellular and molecular mechanisms of lung inflammation and fibrosis; identifying potential targets and agents for IPF therapy; establishing an IPF network, identifying genetic factors that influence sarcoidosis in blacks and genes that increase susceptibility to pulmonary fibrosis; translating basic research findings into clinical applications for LAM; and improving allograft function after lung transplantation.

Lung Cell and Vascular Biology SRG

The Lung Cell and Vascular Biology SRG oversees research on the molecular and cellular biology of epithelial and endothelial cells of the alveoli and the lung surfactant system. Additional areas of interest encompass studies on regulation of the pulmonary vasculature, including cell growth and signaling; cellular and molecular mechanisms of primary pulmonary hypertension; identification of genes related to lung function; and development of new methods to deliver drugs via lung epithelial cells.

Division of Blood Diseases and Resources

The DBDR plans and directs a coordinated research program on the causes and prevention of blood diseases and disorders. Areas of interest encompass a broad spectrum of research from stem cell biology to medical management of blood diseases, with a focus on nonmalignant and premalignant processes. The Division also has a major responsibility to improve the adequacy and safety of the Nation's blood supply. It has recently taken a leading role in developing cell-based therapies, combining the expertise of transfusion medicine and stem cell technology with the exploration of repair and regeneration of human tissues and biological systems.

The Division is organized into three major programs:

• Blood Diseases Program
• Thrombosis and Hemostasis Program
• Blood Resources Program.

Blood Diseases Program

The Blood Diseases Program supports research and training in nonmalignant disorders, including anemias, SCD, and thalassemia. It also supports studies on malaria, iron overload and erythropoiesis, and red cells. The Program comprises one research SRG described below and a Research Training Group that manages training and career development in blood diseases research for individuals at all stages of their professional development.

Hemoglobinopathies and Genetics SRG

The Hemoglobinopathies and Genetics SRG oversees a comprehensive program focusing on reducing morbidity and mortality caused by disorders of the hematopoietic system and preventing their occurrence. Diseases include SCD, thalassemia, Fanconi anemia, and Diamond-Blackfan anemia.

Research in SCD and thalassemia ranges from elucidating their etiology and pathophysiology to improving disease treatment and management. Areas of emphasis include genetics, regulation of hemoglobin synthesis, iron chelation, development of drugs to increase fetal hemoglobin production, and gene therapy. Developing animal models for preclinical studies is another area of interest. Clinical studies in SCD are investigating stroke prevention and the long-term effects of hydroxyurea therapy. A phase III clinical trial is determining whether hydroxyurea is effective in preventing chronic end organ damage in children with SCD.

The SRG oversees a program of Comprehensive Sickle Cell Centers which collectively form a SCD clinical research network. Individually, each center conducts basic and clinical research, delivers state-of-the-art patient care, offers educational activities for patients and health professionals, performs community outreach, and provides genetic counseling services.

A thalassemia clinical network is evaluating new treatment strategies and ensuring that research findings on optimal management of the disease are rapidly disseminated to practitioners and health care professionals.

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Thrombosis and Hemostasis Program

The Thrombosis and Hemostasis Program supports research and training in hemostasis, thrombosis, and endothelial cell biology. Areas of interest include gene transfer, clinical proteomics, inflammation and thrombosis, coagulation activation, autoimmune disease, and thrombotic complications of obesity, diabetes, and cancer. The Program comprises one research SRG described below and a Research Training Group that manages training and career development related to thrombosis and hemostasis.

Thrombosis and Hemostasis SRG

The Thrombosis and Hemostasis SRG oversees a comprehensive program of basic research, clinical studies, and technology development in hemostasis, thrombosis, and endothelial cell biology, with a focus on understanding the pathogenesis of both arterial and venous thrombosis in order to improve diagnosis, prevention, and treatment of thrombosis in heart attack, stroke, and peripheral vascular diseases. A major goal is to find additional platelet inhibitors, anticoagulants, and fibrinolytic agents that will improve specificity and reduce side effects when used in treating thrombotic and thromboembolic disorders. SCORs support collaborative studies on hemostatic and thrombotic disorders.

Finding an effective treatment for hemophilia is another priority. Bleeding disorders associated with defects in coagulation proteins or abnormal platelet function, such as the immune thrombocytopenias, also are being studied.

Blood Resources Program

The Blood Resources Program supports research and research training in transfusion medicine, stem cell biology and disease, clinical cellular medicine, and blood supply adequacy and safety. The Program is organized into one SRG described below.

Transfusion Medicine and Cellular Therapeutics SRG

The Transfusion Medicine and Cellular Therapeutics SRG supports research on the use, safety, and availability of blood and blood components for transfusion and cellular therapies. Areas of interest in transfusion medicine include transmission of disease through transfusion, development of methods to detect and inactivate viruses in donated blood, improvement of blood donor screening procedures, and emerging diseases that may be transmitted by blood transfusions. Also supported are basic and clinical investigations related to transfusion immunobiology, focusing on graft-versus-host disease, graft-versus-leukemia effect, and dendritic cell therapies.

The SRG oversees research on hematopoiesis, stem cell biology and diseases, and cellular therapies. Areas of major focus are determining the factors that cause stem cells to start and stop dividing, move throughout the body, and lodge in a specific place, and understanding the fundamentals of stem cell biology that will lead to cell-based therapies.

The Program also supports two clinical research networks to promote efficient comparison of innovative treatment strategies–one for patients undergoing blood or marrow transplantation and the other for patients with hemostatic disorders, such as idiopathic thrombocytopenia and thrombotic thrombocytopenic purpura. SCORs support collaborative studies on hematopoietic stem cell biology and transfusion biology and medicine.

Division of Epidemiology and Clinical Applications

The DECA supports clinical research on the causes, prevention, and treatment of cardiovascular, lung, and blood diseases and sleep disorders. The Division oversees a broad array of epidemiological studies (including field studies, genetic epidemiology, and clinical epidemiology); clinical trials of interventions to prevent and treat disease (particularly chronic CVD and conditions); demonstration and education research; and basic and applied behavioral studies. Research often focuses on defined populations (e.g., minorities, occupational groups, school children, and health professionals) and community settings. For planning and evaluation purposes, the Division provides statistics on cardiovascular, lung, and blood diseases from national data and cohort studies. The Division is organized into two major research programs:

• Clinical Applications and Prevention Program
• Epidemiology and Biometry Program

and an Office of Biostatistics Research.

Clinical Applications and Prevention Program

The Clinical Applications and Prevention Program supports research and research training on the effects of specific clinical and/or behavioral interventions for prevention and treatment of heart and vascular disease. Research includes efficacy studies to determine whether specific interventions improve disease outcomes under rigorously controlled and ideal circumstances, effectiveness studies to determine whether specific interventions result in favorable outcomes in more applied settings, and translational studies that test interventions to improve the delivery of proven approaches in clinical or public health settings. The Program is organized into the three SRGs described below.

Behavioral Medicine and Prevention SRG

The Behavioral Medicine and Prevention SRG addresses psychological, social, cultural, lifestyle, and other behavioral factors that influence disease etiology, pathophysiology, prevention, and treatment. Included are studies of basic behavioral principles related to health; relationships between psychosocial and lifestyle factors and CVD risk; effects of psychosocial factors in prevention, treatment, and rehabilitation; efficacy and effectiveness of behavioral, psychosocial, or lifestyle interventions to reduce disease risk and improve risk factor levels; effects of health-promotion interventions in community settings; and methods to disseminate effective lifestyle programs to communities. Key topics include stress, depression, social support, adherence, quality of life, diet, physical activity, and obesity.

Clinical Trials SRG

The Clinical Trials SRG supports studies of new therapies for CVD. A central activity of the group is the conduct of multicenter, randomized trials to evaluate therapeutic interventions. In addition to evaluating the usefulness of specific therapies, trials are used to study disease mechanisms as the basis for future interventions. Areas of emphasis include heart failure, coronary artery disease, sudden cardiac death, and supra ventricular arrhythmias, particularly atrial fibrillation.

Clinical Prevention and Translation SRG

The Clinical Prevention and Translation SRG addresses efficacy of risk factor treatments for CVD prevention, particularly studies testing interventions that would be delivered in outpatient clinical settings if successful. Included are pharmacologic treatments of known CVD risk factors and of putative novel risk factors for primary prevention, lifestyle interventions for primary prevention delivered in clinical practice settings, and lifestyle treatments for secondary prevention. The SRG also addresses approaches to improve implementation in clinical practice settings of interventions with proven efficacy, including research on effective methods for disseminating and implementing preventive as well as treatment interventions, consistent with evidence-based guidelines, as an integral part of routine medical care.

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Epidemiology and Biometry Program

The Epidemiology and Biometry Program supports research and research training in epidemiological studies of heart and vascular, lung, and blood diseases and sleep disorders in defined populations in the United States and other countries. Research includes temporal trends and population patterns in prevalence, incidence, morbidity, and mortality from heart, lung, and blood diseases; risk factors for their development and progression; genetic and environmental influences and their interactions in the development of subclinical and clinical heart, lung, and blood diseases and sleep disorders; and design and analysis of long-term observational studies. The Program is organized into the three SRGs and two research units described below.

Analytical Resources SRG

The Analytical Resources SRG is responsible for (1) conducting research in the area of biometric and epidemiologic methods and their application to studies involving the incidence of and mortality from cardiovascular, lung, and blood diseases; (2) applying research strategies using family, longitudinal, and demographic information and vital statistics to study the natural history, etiology, and epidemiology of cardiovascular, lung, and blood diseases; (3) providing the Program and the Institute with statistical and epidemiological consultation including national trends in the morbidity and mortality associated with cardiovascular, lung, and blood diseases; (4) advising the Program, the Institute, and outside investigators on the design and analysis of large prospective epidemiological studies; and (5) compiling, cataloging, and maintaining data sets and files from epidemiologic studies conducted by the Program.

Field Studies and Clinical Epidemiology SRG

The Field Studies and Clinical Epidemiology SRG conducts multicenter cohort studies of the development and progression of CVD and their risk factors in U.S. populations among people of various ages, genders, and racial groups. The SRG convenes working groups to advise on critical new research, proposes epidemiologic research with appropriate study designs, initiates epidemiologic studies, manages large and complex field studies, evaluates study proficiency and productivity, and collaborates on scientific research. The SRG advises the Program and other Divisions on clinical epidemiology, measurements of subclinical CVD, and management of complex and large field-based epidemiologic studies.

Genetic Epidemiology SRG

The Genetic Epidemiology SRG is responsible for (1) conducting research studies focused on twins, pairs of siblings, and families to elucidate genetic and environmental contributors to heart, lung, and blood diseases and to characterize gene–gene and gene–environment interactions; (2) advising the Program, the Institute, and outside investigators on the design and analysis of studies of genetically characterized individuals in epidemiologic studies; (3) promoting the collection, storage, and maintenance of blood samples in existing studies to allow genotypic characterization of study cohort members for analyses in relation to phenotypic data; and (4) maintaining inventories of existing genetic databases and recent findings from ongoing epidemiologic studies conducted by the Program.

Framingham Epidemiology Research Unit

Located in Framingham, MA, the Framingham Epidemiology Research Unit (FERU) collaborates with extramurally funded Framingham investigators to identify and pursue research opportunities in cardiovascular, lung, and blood diseases in the Framingham Cohort and Offspring Studies. FERU staff are involved in all aspects of protocol development; clinic operations; event review; research training; and development of research hypotheses, analyses, reports, and publications.

Jackson Epidemiology Research Unit

Located in Jackson, MS, the Jackson Epidemiology Research Unit (JERU) collaborates with extramurally funded Jackson investigators to identify and pursue research opportunities in cardiovascular, lung, and blood diseases in the Jackson Heart Study. JERU staff members are involved in all aspects of protocol development; clinic operations; event review; research training; and development of research hypotheses, analyses, reports, and publications.

Office of Biostatistics Research

The Office of Biostatistics Research (OBR) provides statistical expertise to the Institute and performs diverse functions in planning, designing, implementing, and analyzing NHLBI-sponsored studies. It has primary responsibility for providing objective, statistically sound, and medically relevant solutions to problems arising in NHLBI-sponsored studies. The OBR is concerned with designing efficient studies and monitoring data from ongoing studies.

The methodological interests of the OBR concern survival analysis, longitudinal data analysis, and efficient study designs, including monitoring ongoing clinical studies for efficacy and safety. Recently the OBR has made contributions to statistical genetics and has extended its expertise to bioinformatics.

National Center on Sleep Disorders Research

The NCSDR plans, directs, and supports basic, clinical, and applied research, health education, training, and prevention research in sleep, chronobiology, and sleep disorders. It oversees developments in its program areas; assesses the national needs for research on causes, diagnosis, treatment, and prevention of sleep disorders and sleepiness; and coordinates sleep research activities across the Federal Government and with professional, voluntary, and private organizations. The Center promotes information sharing and coordinates implementation of interagency programs.

The NHLBI sleep research program seeks to understand the molecular, genetic, and physiological regulation of sleep and the relationship of sleep disorders to CVD. It also supports efforts to understand the relationships of sleep restriction and sleep-disordered breathing to the metabolic syndrome, including obesity, high blood pressure, dyslipidemia, insulin resistance, and vascular inflammation. Ongoing NHLBI-funded research projects include studies to elucidate the etiology and pathogenesis of sleep disorders, particularly sleep apnea; determine the role of sleep apnea in CVD and cerebrovascular disease; examine sleep and sleep disorders in children; and identify new animal models of sleep disorders.

In 2005, the NCSDR coordinated efforts that led to the NIH State of the Science Conference on Manifestations and Management of Chronic Insomnia in Adults, a consensus conference cosponored by the National Institute of Mental Health (NIMH) and the NIH Office of Medical Applications of Research. After considerating the scientific evidence presented, the independent panel of experts released a state-of-the-science statement on insomnia and its treatment, which can be found on the Internet at www.consensus.nih.gov.

Multidisciplinary research training programs in sleep biology and sleep disorders are being supported to ensure that highly trained scientists are available to address important gaps in the current biomedical and biological understanding of sleep, including those outlined in the 2003 National Sleep Disorders Research Plan.

The NCSDR works closely with the NHLBI Office of Prevention, Education, and Control (OPEC) on education pertaining to sleep problems and sleep disorders for physicians, other health care providers, and the general public. Information for the public about sleep apnea was updated and incorporated into the NHLBI Web-based Health Topics at sleep apnea.

Reaching children and adolescents with messages about sleep and sleep disorders is a priority. In 2004, the NCSDR disseminated a new high school supplemental curriculum on the biology of sleep. In 2005, it published in the June issue of Pediatrics a manuscript, "Excessive Sleepiness in Adolescents and Young Adults: Causes, Consequences, and Treatment Strategies," prepared by the NCSDR Working Group on Sleepiness in Adolescents/Young Adults and the American Academy of Pediatrics Committee on Adolescence.

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Women's Health Initiative

The WHI, which was established by the NIH in 1991, was transferred to the NHLBI on October 1, 1997. Its mission is to address the most common causes of death, disability, and impaired quality of life in postmenopausal women. These include heart disease, breast and colorectal cancer, and osteoporosis.

The WHI is a 15-year project consisting of three major components: a randomized, controlled, clinical trial of promising but unproven approaches to prevention; an observational study to identify predictors of disease; and a study of community approaches to developing healthful behaviors.

The clinical trial and the observational study enrolled more than 161,000 women aged 50 to 79, 18.5 percent of whom are minorities. More than 68,000 women were enrolled in one of three clinical trials for 8.5 years with the goal of assessing the preventive use of hormone therapy, diet modification, and calcium and vitamin D supplements.

• The hormone therapy component focused on risks and benefits of combined estrogen (conjugated equine estrogen) and progestin (medroxypro-gesterone acetate) on coronary heart disease (CHD), breast cancer, and osteoporosis risk in women with a uterus, and estrogen alone in women without a uterus.
• The dietary modification component focused on the efficacy of a diet low in fat but high in fruits, vegetables, and grains in preventing breast and colorectal cancers and heart disease.
• The calcium and vitamin D supplements component focused on the efficacy of the two nutrients in preventing fractures and reducing the risk of colorectal cancer.

Women who were ineligible or unwilling to participate in the clinical trial were encouraged to enroll in a concurrent long-term observational study that involved no specific intervention, but tracked their medical history and health habits for 8.5 years. The study was looking for predictors and biological markers–including genetic markers–for disease.

Forty clinical centers recruited postmenopausal women for the clinical trial and the observational study. Ten of the centers recruited primarily minority populations: blacks, Hispanics, Asians, Pacific Islanders, and American Indians.

Unlike the clinical trial and observation study components, the Community Prevention Study component focused on community-based strategies to persuade women, especially those of different races, ethnic groups, and socioeconomic strata, to adopt healthful behaviors. Its goal was to conduct prevention research that translates into model intervention programs, which, in turn, could be widely disseminated to communities throughout the United States. Areas of emphasis included reduction of CVD, especially among black women; peer support among minority women; environmental factors and physical activity; osteoporosis prevention, education, and outreach; diabetes care in minority women; methods to enhance physical activity; and a survey of women's attitudes regarding surgical menopause and hormone therapy. The study was completed in 2000.

On July 9, 2002, after an average of 5.6 years of follow-up, the NHLBI announced an early end to the estrogen plus progestin trial, which was scheduled to run until 2005, because the risks outweighed the benefits. Specifically, investigators discovered increased risks of invasive breast cancer, heart attacks, strokes, and blood clots in study participants on combined hormone therapy of conjugated equine estrogen and medroxyprogesterone compared with women taking placebo pills. They also found decreases in hip fractures and colon cancer in the treatment group compared with the control group. Although the actual increased risk of breast cancer or CVD for women on long-term estrogen plus progestin was small–less than one-tenth of 1 percent per year–applied to the entire population of women over several years, its potential public health impact could be significant.

In 2003, a memory substudy of the WHI found that older women taking combination hormone therapy had twice the rate of dementia, including Alzheimer's disease, compared with women who did not take the medication. The study also found that the combined therapy did not protect against development of mild cognitive impairment, a form of cognitive decline less severe than dementia.

The study of estrogen-alone hormone therapy among women who had a hysterectomy was halted at the end of February 2004 because of safety issues. Investigators found that conjugated equine estrogen resulted in no reduction in CHD risk, but increased the risk of stroke in postmenopausal women who had been followed an average of 6.8 years. The study, which was scheduled to run until March 2005, also found that estrogen-alone therapy significantly increased the risk of deep vein thrombosis, had no significant effect on the risk of breast or colorectal cancer, and reduced the risk of hip and other fractures.

The memory substudy of these women, aged 65 to 79 at the beginning of the trial, showed that older women using estrogen-alone hormone therapy could be at a slightly greater risk of developing dementia, including Alzheimer's disease, than women who do not use any menopausal hormone therapy. In addition, scientists found that estrogen alone did not prevent cognitive decline.

The clinical trials of Dietary Modification and Calcium and Vitamin D Supplements ended in March 2005 as originally planned. Research findings will be published in February 2006.

The participants of the WHI clinical trials and the observational study are partipating in an extension study, which will continue until 2010. Biologic resources (bloods and DNA) from the studies will be available to the broader scientific community in 2006.

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Division of Intramural Research

The DIR conducts laboratory and clinical research in heart, vascular, lung, blood, and kidney diseases and develops technology related to cardiovascular and pulmonary diseases. Areas of interest include the biology of experimental and clinical arteriosclerosis and its manifestations; pathophysiology of hypertensive vascular disease; functions of the lung; clinical and experimental studies on physiologic and pharmacologic aspects of heart, lung, and blood diseases; and a broad program of other basic research and technical development related to them.

In FY 2005, the DIR was reorganized. The Office of the Director, Laboratory Research Program, became the Office of the Scientific Director and the Office of the Director, Clinical Research Program, became the Office of the Clinical Director, which was subsumed within the Office of the Scientific Director. Clinical branches and their laboratories and sections were abolished and four new branches were established: the Cardiovascular Branch, the Hematology Branch, the Pulmonary Critical Care Medicine Branch, and the Vascular Medicine Branch.

The reorganized DIR includes the following four Centers and four Branches:

Biochemistry and Biophysics Center

The Biochemistry and Biophysics Center develops a global view of the molecular basis of structure–function relationships of proteins and biologically relevant molecules. It performs state-of-the-art nuclear magnetic resonance spectroscopy studies of protein structure and functional interactions, develops mathematical tools for generating theoretical models of protein structure–function relationships, elucidates the mechanisms of enzyme function, and investigates the relationship between protein stucture–function and cell signaling pathways.

Cell Biology and Physiology Center

The Cell Biology and Physiology Center develops a global view of the mechanisms that regulate cellular function and physiology. It evaluates the mechanisms that control different molecular machines within the cytosol, including those involved in muscle contraction, and cytosolic and membrane transport processes. The Center studies cellular signaling events associated with hormone action, cytosolic trafficking, and energy metabolism; investigates the role of cellular processes on function and adaptation in whole animal model systems; and develops unique measuring devices for studying biochemical and physiological processes in intact cells, whole animals, and clinical situations.

Genetics and Development Biology Center

The Genetics and Development Biology Center develops a global view of the mechanisms that regulate cardiovascular development and the etiology of congenital heart anomalies and CVD. It evaluates the function of specific genes and transcription factors in the development of the heart and other tissues, develops techniques and approaches for gene delivery and gene therapy in model systems, and works toward a better understanding of basic processes involved in regulating and interpreting the genetic code in development and disease.

Immunology Center

The Immunology Center develops a global view on the molecular basis of immune processes. It studies the intracellular and signaling processes involved in the activation of lymphocytes and mast cells, investigates the mechanisms by which drugs and other agents result in allergic–autoimmune reactions, and relates the results to the development of new diagnostic and therapeutic approaches in humans.

Cardiovascular Branch

The Cardiovascular Branch develops diagnostic and therapeutic modalities for the treatment of CVD. It investigates laboratory-based mechanistic studies and innovative clinical protocols.

Hematology Branch

The Hematology Branch conducts basic and clinical research on normal and abnormal hematopoiesis. Areas of interest include bone marrow failure, viral infections of hematopoietic cells, gene therapy of hematologic and malignant diseases, bone marrow transplantation, and mechanisms of immunologically mediated syndromes such as graft-versus-host disease and autoimmune diseases.

Pulmonary Critical Care Medicine Branch

The Pulmonary Critical Care Medicine Branch conducts research on the lung and cardiovascular system directed at defining, on the molecular level, normal function and disease. It focuses on the integration of biochemical, molecular, biological, and immunological events into an understanding of intra- and intercellular communications and organ function.

Vascular Medicine Branch

The Vascular Medicine Branch conducts research on the lung and vasculature directed at defining, on a molecular, biochemical, and functional level, normal physiological function and novel mechanisms of disease. It focuses on translational study and therapeutic modulation of these functions to mitigate vasculopathy in lung and heart disease.

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Office of Prevention, Education, and Control

The Institute's OPEC coordinates the translation and dissemination of research findings and scientific consensus to health professionals, patients, and the public, so that information can be adapted for, and integrated into, health care practice and individual health behavior. NHLBI health education programs and initiatives established through the OPEC address high blood pressure, high blood cholesterol, asthma, early warning signs of heart attack, obesity, sleep disorders, women's heart health, PAD, and COPD. For reducing high blood pressure, high blood cholesterol, and obesity, two approaches are used: one focuses on individuals at high risk and the other on the general public. Special attention is given to minority populations that are disproportionately affected by disorders within the Institute's mandate.

The four largest education programs have coordinating committees consisting of national medical, public health, and voluntary organizations and other Federal agencies, which help to plan, implement, and evaluate the Institute's professional, patient, and public education programs.

The National High Blood Pressure Education Program (NHBPEP) was initiated in 1972 to reduce death and disability related to high blood pressure. It employs a comprehensive strategy to mobilize, educate, and coordinate groups concerned with hypertension prevention and control. Major activities include developing and disseminating educational materials and programs that are grounded in a strong science base.

In 2004, the Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents was published as a supplement to Pediatrics; the Institute's version of the report, along with a Pediatric Hypertension Clinical Reference Tool for Palm OS and Pocket PC, which was designed to support the use of the guidelines, can be downloaded from the NHLBI Web site.

The NHBPEP launched its "Prevent and Control High Blood Pressure: Mission Possible" campaign in 2005 to help health care and other organizations nationwide promote high blood pressure prevention and control more aggressively among their constituents and to enlist support from organizations that have not traditionally been involved with high blood pressure activities. A Web site was designed to include ideas and materials for activities that business organizations, schools, community and civic organizations, and provider groups can use to become involved.

The National Cholesterol Education Program (NCEP) was initiated in 1985 to educate health professionals and the public about high blood cholesterol as a risk factor for CHD and about the benefits of lowering cholesterol levels to reduce illness and death from CHD. Its goal is to reduce the prevalence of elevated blood cholesterol in the United States, and thereby contribute to reducing CHD morbidity and mortality.

In 2005, the NCEP, along with the NHLBI Obesity Education Initiative, developed Your Guide to Lowering Your Cholesterol With TLC, which provides advice on implementing therapeutic lifestyle changes (TLC)–diet, physical activity, and weight management–to control elevated blood LDL cholesterol levels, as well as the metabolic syndrome. It published a joint statement with the American Heart Association on the diagnosis and management of the metabolic syndrome, a cluster of cardiovascular risk factors that is associated with obesity, and developed a paper, Trends in Serum Lipids and Lipoproteins of Adults: National Health and Nutrition Examination Surveys, 1960–2002, with the National Center for Health Statistics (NCHS). The paper shows that total and LDL cholesterol levels have continued to decline in the older age groups, and the percent of U.S. adults with high total cholesterol levels (240 mg/dL or above) has fallen to 17 percent, thereby meeting one of the Healthy People 2010 objectives for the Nation.

The National Asthma Education and Prevention Program (NAEPP) was initiated in 1989 to raise awareness of asthma as a serious, chronic disease; to promote more effective management of asthma through professional, patient, and public education; and to provide up-to-date information on asthma care. The Program works with schools, health care professionals, and patients to improve asthma care, prevent disruptions of daily routine, limit hospitalizations, and reduce deaths caused by uncontrolled asthma. Special attention is directed to minority, low-income, and underserved populations who are at increased risk.

The NAEPP employs a number of outreach strategies. Major emphasis is placed on developing, disseminating, and implementing national guidelines on the diagnosis and management of asthma. In 2005, the NAEPP issued new treatment guidelines for managing asthma during pregnancy that emphasize the importance of controlling asthma during pregnancy not only for the well-being of the mother, but also for the healthy development of the fetus.

The National Heart Attack Alert Program (NHAAP) was initiated in June 1991 to reduce morbidity and mortality from heart attack, including out-of-hospital cardiac arrest, through education of health care providers, patients, and the public, about the importance of rapid identification and treatment of individuals with heart attack symptoms. In 1997, the Program's scope was broadened to include early identification and treatment of individuals with unstable angina, thereby including the full spectrum of acute coronary syndromes.

In 2005, the NHAAP continued to promote the "Act in Time to Heart Attack Signs," a campaign that creates national and local partnerships to urge physicians and allied health care providers to educate their patients about heart attack risk, warning signs, and steps to ensure early treatment and survival. Educational materials for the public and for health care providers are available from the NHLBI Web site.

The NHLBI Obesity Education Initiative (OEI) was launched in January 1991 to inform the public and health professionals about the health risks associated with overweight and obesity. Obesity is not only an independent risk factor for CVD, but also a contributor to high blood pressure, type 2 diabetes, and high blood cholesterol and is related to sleep apnea.

The NHLBI OEI employs a comprehensive strategy to mobilize, educate, and coordinate groups interested in preventing and treating overweight and obesity. One of the major NHLBI OEI prevention activities, which was conducted in collaboration with the National Recreation and Park Association, is "Hearts N' Parks," a national community-based program located in 50 at-risk communities in 11 magnet center States. In 2005, the magnet centers completed their third year of programs, which included encouraging Americans of all ages to seek a healthy weight, follow a heart healthy eating plan, and engage in regular physical activity while participating in local park and recreation department programs. The "Hearts N' Parks" Web site includes programmatic details for each magnet center for each of the 3 years.

In 2005, the NHLBI, in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Child Health and Human Development (NICHD), and the NCI, launched "We Can!" (Ways To Enhance Children's Activity and Nutrition), a national education program to prevent overweight and obesity among youth, ages 8 to 13. Major elements of the program include partnerships and community national media, and consumer outreach. Resources are available for parents, caregivers, youth, and community groups to encourage healthy eating, increase physical activity, and reduce sedentary time at http://wecan.nhlbi.nih.gov.

Since the launch of The Heart Truth campaign in 2002, the NHLBI has formed an extensive cadre of community, media, and corporate partners who are supporting the Institute's goal of reaching women with critical messages about heart health and promoting the Red Dress as the national symbol for women and heart disease awareness. Outreach to women at the community level has been enhanced by The Heart Truth Road Show, Single City Program, and events held by First Lady Laura Bush, the campaign's national ambassador. A key focus for the campaign is to expand outreach to women of color through the Communities of Color Partnership effort implemented in 2005.

Over the past few years, the NHLBI has been working with the vascular community to identify educational needs related to PAD. In 2005, the Institute awarded a 3-year contract to plan, develop, and implement an NHLBI PAD awareness campaign for use by professional and public interest groups. The campaign is being designed to raise awareness of the signs and symptoms of PAD, encourage those at risk to seek diagnosis and treatment, and educate the public about PAD risk factors. The NHLBI has collaborated closely with the PAD Coalition in planning campaign strategies and will continue to involve the Coalition and other interested organizations in upcoming campaign activities.

COPD is a new area of education emphasis for the NHLBI. The Institute's 2004 strategy development workshop on COPD yielded recommendations for a national education initiative. In 2005, a 3-year contract was awarded for planning, developing, implementing, and evaluating a COPD awareness and education campaign.

Educational activities associated with von Willebrand disease were initiated in 2004. In response to a congressional recommendation, the NHLBI convened an expert panel to review the current science on the diagnosis and treatment of von Willebrand disease and to formulate clinical guidelines. Completion of the guidelines and their dissemination are scheduled for 2006.

The OPEC also is responsible for coordinating the Institute's nutrition program. The NHLBI Nutrition Coordinator serves as a major source of nutrition policy and nutrition science knowledge and advises the NHLBI Director on nutrition program policies and priorities. The Coordinator also is the Institute's representative to other relevant components of the NIH, the U.S. Department of Health and Human Services (DHHS), and other components of the Federal Government on nutrition research and policy. Major activities include contributing to the revision of the Dietary Guidelines for Americans, which was released jointly by the DHHS and the U.S. Department of Agriculture (USDA) in 2005; joining in the DHHS/USDA dialogue on revising the Food Guide Pyramid; and working with the U.S. Food and Drug Administration on changes to consumer education efforts related to food labels.

As a key part of its response to the Healthy People 2010 Objectives for the Nation, the NHLBI initiated a new funding mechanism in 2001 to establish CVD educational outreach programs in high-risk communities. The program–Enhanced Dissemination and Utilization Centers (EDUCs)–is a partnership between the NHLBI and local communities to eliminate cardiovascular health disparities and improve the health of underserved populations. Since its inception, two sets of six EDUCs have been awarded that served more than 31 communities in 10 States. The first set of EDUCs ended in 2004; the second set was completed in December 2005. The lessons learned from the EDUCs will provide valuable information to other communities interested in conducting CVD outreach and education activities.

Since the NHLBI planning workshop, "Education Strategy Development Workshop–Public Health in Public Housing: Improving Health, Changing Lives," conducted in 2004, the NHLBI has held exploratory discussions with potential partners to implement clinical and public health activities in public housing communities. The goal of the program is to improve prevention and control of CVD risk factors and enhance adoption of healthy lifestyle behaviors by public housing residents.

The Institute's "Salud para su Corazón" (Health for Your Heart) Initiative, a community-based heart health program for Latinos, has expanded across the United States to include communities along the Texas-Mexico border and along the southern border areas of California and New Mexico. Trained local lay health workers (promotores de salud), applying the values and culture of the community, teach individual and patients how to reduce their risk of developing CVD. As advocates for change, lay health workers have increased the number of Latinos in their communities who are engaging in heart healthy behaviors.

The NHLBI and the Indian Health Service have worked together since 2000 to bring heart health to American Indian and Alaska Native (AI/AN) communities. Initial steps were focused on identifying the unique needs and issues that affect tribal communities. The NHLBI developed a training manual, Honoring the Gift of Heart Health, for community instructors to enable them to provide a culturally sensitive course on heart health. In 2003, a national workshop to train the trainers was held for key tribal leaders and health practitioners in AI/AN communities nationwide. It produced instructors equipped to conduct future training sessions. In 2005, three regional skills-building training workshops were completed. The regional workshops continue to produce local community skills-building workshops, to build local tribal capacity and to extend the reach to include other nearby tribes.

The NHLBI's Asian American and Pacific Islander Cardiovascular Health Outreach effort focuses on four underserved groups with high blood pressure, obesity, physical inactivity, and smoking. Individuals of Philippine, Vietnamese, Cambodian, and Native Hawaiian heritage comprise the current targeted audiences. To date, educational materials on cardiovascular health have been developed for the Filipino and Vietnamese communities. A school-based intergenerational cardiovascular health curriculum to educate Native Hawaiian elementary school children is being developed.

The NHLBI initiated the "Keep the Beat" program in January 2004 to promote heart healthy behaviors for its employees and to encourage them to become more physically active. A key component of the program was the introduction of on site "Take 10" rooms where employees can go to use 10–15 minutes of their daily break time to participate in a low-impact physical activity of their choice.

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International Activities

The Institute is a world leader in research and policy development in heart, lung, and blood diseases, sleep disorders, and blood resources. Through its international programs, the NHLBI contributes to, and benefits from, the rapidly developing global knowledge base in medicine, science, and technology related to its mission.

The Institute's international activities are conducted through multiple mechanisms, including government-to-government and institute-to-institute agreements; joint research projects; joint symposia and workshops; and joint documents, publications, grants, contracts, and fellowships. In addition, the Institute is providing training in its laboratories to international research fellows from approximately 30 countries. Canada, India, Italy, Japan, Korea, Poland, Russia, and Vietnam are among the countries that have maintained collaborative working relationships with the NHLBI. The partnerships extend the benefits of the Institute's prevention and treatment programs to other countries.

The Director and senior NHLBI staff serve as consultants to, and partners with, the Pan American Health Organization (PAHO) and the World Health Organization (WHO). Last year, in recognition of its leadership and contributions to global and international health, the NHLBI was redesignated as a WHO Collaborating Center for Research and Training in Cardiovascular Diseases in the Americas. Through its activities as a PAHO/WHO collaborating center, the Institute is addressing the pandemic of CVD in North, Central, and South America and the Caribbean. In 2004, it sponsored a workshop, "Charting New Directions for Cardiovascular Disease Prevention and Control in the Americas," that was followed up by a symposium, "Lay Health Workers/Promotores de Salud: Mobilizing Communities, to Improve Heart Health in the Americas," in 2005.

Plans for continued regional collaboration include implementing performance-based demonstration projects that will conduct and evaluate promising community-based interventions to prevent heart disease in low-resource countries in the Americas. The projects include collaboration with PAHO's CARMEN Network and NHLBI programs such as "Salud para su Corazón" and EDUCs to establish a repository of tools and methodologies that can be disseminated broadly among interested partners in the region.

The NHLBI and the Institute of Circulatory and Respiratory Health, Canadian Institutes of Health Research (CIHR), continue their collaborative effort in cardiovascular, pulmonary, and blood diseases research that began in 2003. Joint programs were implemented in the following areas:

• Clinical Research Consortium To Improve Resuscitation Outcomes
• Cellular and Molecular Imaging of the Cardiovascular, Pulmonary, and Hematopoietic Systems
• Inflammation and Thrombosis.

The NHLBI supports efforts to encourage collaboration and new research endeavors for rare diseases. In the area of blood diseases, the Institute supports a collaborative effort with Ghana to compare the differences in epidemiology and etiology of infections in SCD between Africa and the United States. In July 2005, the Sickle Cell Center at the Children's Hospital of Philadelphia and the Sickle Cell Foundation of Ghana held the 5th International African Symposium on Sickle Cell Disease, in Accra, Ghana. The Institute also supports clinical studies on Cooley's anemia in the United Kingdom and has initiated research into the genetics and basic mechanisms of Diamond-Blackfan anemia and other rare inherited bone marrow failure syndromes with Australia, Canada, and Sweden.

A working group of national and international experts in Transfusion Medicine developed the NHLBI Strategic Plan on Global Blood Safety in 2004. The working group identified research areas to strengthen national blood programs and transfusion services in developing countries using current grant mechanisms. It provided recommendations to the NHLBI on effective interventions to prevent transmission of HIV/AIDS and other blood-borne infections through blood products.

The Retrovirus Epidemiology Donor Study (REDS) added an international component to conduct epidemiologic, laboratory, and survey research on blood donors in selected developing countries in regions seriously affected by the HIV/AIDS epidemic such as Africa, Asia, and South America to increase the safety and availability of blood for transfusion.

Understanding malarial anemia is a primary concern in many parts of the world, especially in sub-Sahara Africa, where severe anemia is one of the deadliest complications in children infected with malaria. The Institute is supporting research in Kenya to identify the pathogenesis of severe malarial anemia in children.

All of these activities strengthen the Institute's international partnerships and coalitions and extend the benefits of the Institute's research, prevention, and treatment programs to other countries.

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