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2. Program Overview

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, genomic, and proteomic research, systems biology, 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.

Over the past year, the Institute has undergone a major restructuring of its organization to better meet the challenge of its vision to be an international leader through support of innovative, creative, cutting edge research in heart, lung, blood, and sleep research. The reorganization was directed to strengthen scientific coordination by seeking specialized depth in specific disease areas, integrating basic research and clinical trials components, and emphasizing prevention and fostering population sciences. The Division of Heart and Vascular Diseases (DHVD) and the Division of Epidemiology and Clinical Applications (DECA) were totally reorganized and subsequently renamed as the Division of Cardiovascular Diseases (DCVD) and the Division of Prevention and Population Sciences (DPPS), respectively. The Blood Resources Program in the Division of Blood Diseases and Resources (DBDR) was renamed the Transfusion Medicine and Cellular Therapeutics Branch. Framingham investigators were given intramural designation within the Office of Director. The National Center on Sleep Disorders Research (NCSDR) and the WHI were moved from the Office of the Director to the Division of Lung Diseases (DLD) and the DPPS, respectively.

The Office of the Director was augmented by the addition of (1) an Associate Director for Basic Research who is responsible for overseeing NHLBI basic science policies, developing and integrating basic sciences initiatives within the Institute, and coordinating these policies and programs with other NIH institutes and Federal agencies; (2) a Deputy Ethics Counselor who is responsible for managing the Institute’s ethics program and serving as the authorizing official for all ethics clearances; (3) an Office of Biostatistics; (4) an Office of Clinical Research; (5) a Center for Research Informatics and Information Technology (CRIIT); and (6) a Center for Population Studies.

The Office of Biostatistics, which was located in the DECA, provides statistical expertise to the Institute and performs diverse functions in designing, implementing, monitoring, and analyzing NHLBI-sponsored studies. It is responsible for providing objective, statistically sound, and medically relevant solutions to problems arising in NHLBI-sponsored studies; developing new statistical methods for use in analyzing results from clinical trials, population studies, and environmental studies; and initiating research in theoretical biostatistics based upon trends in current research developments. Recently the Office has made contributions to statistical genetics and has extended its expertise to bioinformatics.

The Office of Clinical Research serves as the central clinical research office for extramural affairs. Its role is to coordinate regulatory activities associated with clinical research internally among NHLBI extramural Divisions and externally with NIH Institutes and other government agencies. The Office provides education and training for staff managing clinical research. Additionally, it coordinates and advises extramural scientific and health care staff, principal investigators, and research staff on issues related to all aspects of monitoring and regulatory compliance. The Office maintains central databases and policies and evaluates existing programs for standardizing data collection in clinical trials. It implements research informatics solutions and maintains surveillance over developments in designated areas of responsibility.

Center for Research Informatics and Information Technology

The CRIIT was established in June 2006 to provide an integrated informatics and knowledge environment for the NHLBI. It focuses on computing as it relates to the Institute’s mission: conducting basic and clinical research, administering extramural research programs, and educating health care practitioners and the general public. The Center is organized into four branches:

Research and Biomedical Informatics Branch

The Research and Biomedical Informatics Branch develops computational methods to enhance the Institute’s research mission, its administrative activities, and its education mission. Activities include designing an information and computing infrastructure to support clinical and translational research; providing bioinformatic support and standardizing terminology used in basic, translational, and clinical research; and providing guidance on complex modeling and analytics in bioinformatics, genomics, and proteomics and imaging.

IT Resources Branch

The IT Resources Branch is responsible for ensuring that the NHLBI personnel have continuous access to appropriate network resources needed to carry out the Institute’s mission. It oversees the installation and maintenance of users’ desktops, peripherals, and other computing hardware; assists individuals in optimal use of a defined collection of productivity tools; and ensures that all computer and user practices are compliant with NIH standards for information security.

Applications Development and Support Branch

The Applications Development and Support Branch provides or develops software engineering methods to address the high-priority needs of the Institute. The Branch keeps abreast of the evolving IT field to ensure that the Institute is current in the state-of-the-art of IT applications. It designs methods to allow the outside community to be able to access existing IT resources and educates users to take maximum advantage of these applications.

Planning, Architecture, Communication, and Evaluation Branch

The Planning, Architecture, Communication, and Evaluation Branch relies on a network of Constituency Groups to collect information relevant to the planning of all IT activities for the Institute. The Constituency Groups advise and assign priority to projects to be undertaken. Activities of the Branch include developing an information architecture that will be the blueprint for all future developments; evaluating deployed IT systems to determine their effectiveness and making improvements when necessary; designing methods to communicate with the NHLBI community, both internal and external, about relevant Institute activities; and developing methods to manage information relevant to the Institute’s mission such as procedural knowledge (e.g., administrative practices) and scientific knowledge created by the Institute’s programs.

Center for Population Studies

The Center for Population Studies conducts research using data from the NHLBI Framingham Heart Study to advance the understanding of the etiology, natural history, and temporal trends in heart, lung, and blood diseases and sleep disorders from various disciplines. It develops and oversees training in population research in heart, lung, and blood disorders; conducts collaborative scientific research with the Jackson Heart Study and other NHLBI population studies; and performs state-of-the-art research of heart, lung, blood, and sleep conditions with attention to early onset diseases, their biochemical milieu, and genetic susceptibility.

NHLBI Programs

The programs of the NHLBI, as shown on page 12, are implemented through four extramural units: the DCVD, the DLD, the DBDR, and the DPPS; and one intramural unit, the Division of Intramural Research (DIR). The extramural Divisions 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 (STTR) grants, Specialized Centers of Research (SCORs) and Specialized Centers of Clinically Oriented Research (SCCORs) grants, comprehensive center grants, contracts, and research training and career development programs. Descriptions of the Divisions and the Office of Prevention, Education, and Control (OPEC) follow.

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Division of Cardiovascular Diseases

The DCVD provides leadership for a national and international extramural program in CVD that integrates basic science and clinical research, including translational research, networks, and multicenter clinical trials. It designs, conducts, supports, and oversees research on the causes and prevention and treatment of diseases and disorders such as atherothrombosis, coronary artery disease, myocardial infarction (MI) and ischemia, heart failure, arrhythmia, sudden cardiac death, adult and pediatric congenital heart disease, cardiovascular complications of diabetes and obesity, and hypertension. It also supports and oversees research in vascular medicine and biology and valvular, cerebral, renal, peripheral, and other cardiovascular disorders. The DCVD fosters biotechnological research in genomics, proteomics, nanotechnology, imaging, device development, cell- and tissue-based therapeutics, and gene therapy, and in their uses as they relate to CVD. It also supports training and career development programs in cardiovascular research at all educational levels from high school students to academic faculty, including programs for individuals from diverse populations. SCORs support collaborative studies on molecular medicine and atherosclerosis medicine. SCCORs support clinical collaborative research in (1) cardiac dysfunction and disease, (2) pediatric heart development and disease, (3) vascular injury, repair, and remodeling.

The Division is organized into the five Branches and Office described below.

Advanced Technologies and Surgery Branch

The Advanced Technologies and Surgery Branch conducts and manages an integrated basic and clinical research program to study innovative and developing technologies for the diagnosis, prevention, and treatment of CVD. It promotes opportunities to translate promising scientific and technological advances from discovery through preclinical studies to clinical trials. Areas supported by the Branch include:

  • Diagnostics: proteomic, genomic, and other biomarker technologies and imaging modalities/agents to identify CVD and guide therapy.
  • Therapeutics: tissue-, cell-, and gene-based/guided therapies; regenerative and reparative medicine; and devices for circulatory and cardiac support and repair.
  • Surgery: improved surgical and image-guided approaches and evidence-based clinical research to advance promising new cardiovascular therapies, technologies, and surgical practices into clinical use.
  • Enabling Technologies: bioinformatics, computational and systems biology, bioengineering, nanotechnology, materials research, and personalized medicine.

Programs Supported by the National Heart, Lung, and Blood Institute

Cardiovascular Diseases

Advanced Technologies and Surgery
Diagnostics Development
Emerging Therapeutics
Enabling Technologies
Surgery Advances

Atherothrombosis and Coronary Artery Disease
Acute and Chronic Coronary Syn-dromes
Acute and Silent Ischemia
Coronary Artery Disease
Myocardial Infarction

Heart Developmental and Structural Disease
Adult Congenital Disease
Cardiac Immunology and Infection
Cardiovascular Development
Heart Transplantation
Pediatric Cardiovascular Disease
Valvular Heart Disease

Heart Failure and Arrhythmias
Heart Failure
Myocardial Protection
Sudden Cardiac Death

Vascular Biology and Hypertension
Cerebrovascular Disease
Lymphatic Diseases
Peripheral Vascular Disease
Renal Vascular Disease
Vascular Biology
Vascular Development and Angiogenesis

Lung Diseases

Airway Biology and Disease
Chronic Obstructive Pulmonary Disease (COPD) and Environmental Lung Diseases
Cystic Fibrosis (CF)
Genetics, Genomics, and Biotechnology

Lung Biology and Disease
Acquired Immunodeficiency Syndrome (AIDS) and Tuberculosis (TB)
Critical Care and Acute Lung Injury
Developmental Biology and Pediatric Lung Disease
Immunology and Fibrosis
Lung Cell and Vascular Biology

National Center on Sleep Disorders Research
Sleep Disorders and Related Conditions

Blood Diseases and Resources

Blood Diseases
Red Cells
Sickle Cell Disease (SCD)

Thrombosis and Hemostasis
Hematologic Immune Disorders
Hemophilia and Other Bleeding Disorders

Transfusion Medicine and Cellular Therapeutics
Hematopoietic Stem Cell Transplantation
Immune Deficiencies, Reconstitution, Response, and Tolerance
Myelodysplasia, Marrow Failure, and Myeloproliferative Disorders
Novel Cellular Therapies for Repair and Regeneration
Stem Cell Biology
Transfusion Medicine Use, Safety, and Availability        of Blood and Blood Components

Prevention and Population Sciences

Clinical Applications and Prevention
Behavioral Medicine and Prevention
Clinical Prevention and Translation

Analytical Resources
Field Studies and Clinical Epidemiology
Genetic Epidemiology

Women’s Health Initiative

Intramural Research

Clinical Research
Cardiothoracic Surgery
Pulmonary/Critical Care Medicine

Laboratory Research
Biochemical Genetics
Cardiac Energetics
Cell Biology
Cell Signaling
Developmental Biology
Kidney and Electrolyte Metabolism
Molecular Cardiology
Molecular Immunology
Molecular Physiology

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Atherothrombosis and Coronary Artery Disease Branch

The Atherothrombosis and Coronary Artery Disease Branch conducts and manages an integrated basic and clinical research program to study the etiology, pathogenesis, prevention, diagnosis, and treatment of coronary artery disease and atherothrombosis. It is responsible for translating promising scientific and technological advances from discovery through preclinical studies to networks and multisite clinical trials. Areas addressed by the Branch include:

  • Atherothrombosis: initiation, progression, and regression of atherosclerotic lesions in coronary arteries and other arterial beds; lesion instability and thrombosis; risk factor mechanisms; interaction of lipid fractions and other systemic and humoral factors with the arterial wall; biomarker and imaging diagnostics to quantify atherosclerotic disease and its progression; vulnerable plaques and vulnerable patients; and diabetes, obesity, other metabolic disorders, and diet and exercise related to atherothrombosis.
  • Coronary Artery Disease: acute and chronic coronary syndromes including myocardial infarction, acute ischemia and related events, angina, and silent ischemia; and percutaneous and surgical revascularization of stenotic and restenotic coronary lesions.

Heart Development and Structural Disease Branch

The Heart Development and Structural Disease Branch conducts and manages an integrated basic and clinical research program to study normal and abnormal cardiovascular development. It also is responsible for overseeing research related to the etiology, pathogenesis, prevention, diagnosis, and treatment of pediatric and adult structural heart disease. The Branch is a focal point for coordination of activities and development of educational materials related to clinical research on pediatric CVD within the NHLBI and the NIH. It promotes opportunities to translate promising scientific and technological advances from discovery through preclinical studies to network and multisite clinical trials. Areas supported by the Branch include:

  • Heart Development: normal and abnormal cardiovascular development, molecular and genetic etiology of cardiovascular malformations, cardiomyogenic differentiation of stem cells, and gene environment interactions in development of congenital heart disease.
  • Structural Disease: congenital heart disease from embryology through adulthood, valve disease and determinants of degeneration, myocardial response to valvular disease, neurodevelopmental outcome in congenital heart disease, exercise physiology in congenital heart disease, pediatric cardiomyopathy and heart transplantation, and pediatric cardiac inflammation and infection.

Heart Failure and Arrhythmias Branch

The Heart Failure and Arrhythmias Branch conducts and manages an integrated basic and clinical research program to study normal cardiac function and pathogenesis to improve diagnosis, treatment, and prevention of heart failure and arrhythmias. It promotes opportunities to translate promising scientific and technological advances from discovery through preclinical studies to multisite and network clinical trials. Areas supported by the Branch include:

  • Heart Failure: devices and medical and cell-based therapies targeting heart failure, myocardial protection, and pathogenesis and treatment of heart failure and cardiomyopathies.
  • Arrhythmias: arrhythmogenesis, genetic and environmental bases of normal cardiac electrical activity and arrhythmias, etiology of rare and common arrhythmias, and sudden cardiac death.
  • Myocardial Protection: myocardial preconditioning, amelioration and prevention of myocardial stunning and hibernation, and protection from ischemic/reperfusion injury.
  • Resuscitation Science: mechanisms and management of clinical and experimental pathophysiologic states of whole body oxygen deprivation; systemic hypovolemia and resulting multiorgan failure; organ preservation; and cell, tissue, and organ protection during cardiac arrest and traumatic shock.

Vascular Biology and Hypertension Branch

The Vascular Biology and Hypertension Branch conducts and manages an integrated basic and clinical, extramural, research program to investigate vascular biology and the etiology, pathogenesis, prevention, diagnosis, and treatment of hypertension and vascular diseases. It promotes opportunities to translate promising scientific and technological advances from discovery through preclinical studies to networks and multisite clinical trials. Areas supported by the Branch include:

  • Vascular Biology: biology of the vascular wall; vascular biology (related to hypertension; cerebrovascular, renal, and peripheral vascular disease; aneurysms; and lymphatic diseases); development of arteries, veins, lymphatics, and microcirculation; and angiogenesis.
  • Vascular Medicine: cerebrovascular, renal, and peripheral vascular disease; and aneurysms.
  • Hypertension: blood pressure regulation including central, renal, and vascular control and cerebrovascular disease resulting from high blood pressure.

Office of Research Training and Career Development

The Office of Research Training and Career Development supports training and career development programs in cardiovascular research, offering opportunities to individuals at all educational levels from high school students to academic faculty, including programs for individuals from diverse populations. The programs promote opportunities for investigators, early in their research careers and under mentorship from senior scientists, to perform basic, preclinical or clinical cardio vascular research and to take emerging and promising scientific and technological advances from discovery through preclinical and clinical studies. The Office also collaborates with the scientific community and professional organizations to ensure that training programs meet both the current and future needs of the cardiovascular research workforce. Programs supported by the Office include:

  • Institutional and individual research training programs and fellowships for training of promising cardiovascular scientists at the predoctoral, postdoctoral, junior faculty, and established investigator levels
  • Diversity Supplements to ongoing research grants for support of young investigators from diverse backgrounds, from the high school to the junior faculty level
  • The Pathway to Independence Program, which allows the recipient to bridge the gap between a career development award and a research award
  • Career development programs specifically designed for clinical research or for minority researchers and institutions.

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Division of Lung Diseases

The DLD plans and directs a coordinated research program on the causes and progression of lung diseases and sleep disorders including their prevention, diagnosis, and treatment. It supports basic research, clinical trials, national pulmonary centers, technological development, and application of research findings. 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 airway biology and pathogenesis of CF; cellular and molecular mechanisms of asthma; pathobiology of lung development; pathobiology of fibrotic lung disease; and neurobiology of sleep and sleep apnea. SCCORs support collaborative studies on translational research in acute lung injury and host factors in chronic lung diseases. Other important activities supported by the Division include demonstration and education projects to transfer basic research and clinical findings to health care professionals and patients and training and career development programs for individuals interested in furthering their professional abilities in lung diseases research. The DLD, through the NCSDR, also coordinates sleep research activities across the NIH, other Federal agencies, and outside organizations.

The Division is organized into three major research branches:

Airway Biology and Disease Branch

The Airway Biology and Disease Branch supports research and research training in asthma, COPD, CF, and airway function in health and disease. Basic research focuses on elucidating the etiology and pathophysiology of the diseases. Clinical studies focus on improving asthma management and reducing health disparities in asthma; improving COPD treatment and management; and developing genetic, pharmacologic, and nonpharmacologic (e.g., gene transfer) treatments for CF.

Lung Biology and Disease Branch

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; and interstitial lung diseases and lung immunology including pulmonary fibrosis, sarcoidosis, and pulmonary manifestations of human immunodeficiency virus (HIV)/AIDS and associated infections with emphasis on active and latent TB and drug resistant TB. Basic research focuses on lung development and cell biology, including stem cell biology and cell based therapies, and mechanisms of disease etiology and pathogenesis. Clinical studies focus on evaluating innovative therapies for acute lung injury and acute respiratory distress syndrome (ARDS), pulmonary fibrosis, neonatal lung disease, pulmonary embolism, and pulmonary hypertension.

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 and stroke, dyslipidemia, insulin resistance, and vascular inflammation. Ongoing NHLBI-funded research projects include elucidating the etiology and pathogenesis of sleep disorders, particularly sleep apnea; determining the role of sleep apnea in CVD and cerebrovascular disease; examining sleep and sleep disorders across the lifespan; and identifying new animal models of sleep disorders.

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Division of Blood Diseases and Resources

The DBDR plans and directs research and research training 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. It recently has 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. SCCORs and other specialized centers support collaborative clinical research in hemostatic and thrombotic disorders, SCD, transfusion biology and medicine, and cell-based therapy for blood diseases. The Division also has a major responsibility to improve the adequacy and safety of the Nation’s blood supply.

The Division is organized into three major branches:

Blood Diseases Branch

The Blood Diseases Branch supports research and research training in nonmalignant disorders of the hematopoietic system including SCD and thalassemia. Attention is focused on reducing morbidity and mortality caused by the disorders and preventing their occurrence.

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 Branch oversees a program of Comprehensive Sickle Cell Centers, which collectively form a SCD clinical research network—and which individually conduct basic and clinical research—and provide state-of-the-art patient care, educational activities for patients and health professionals, community outreach, and 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.

Thrombosis and Hemostasis Branch

The Thrombosis and Hemostasis Branch supports research and research training in hemostasis, thrombosis, and endothelial cell biology. It oversees a comprehensive program of basic research, clinical studies, and technology development focusing on understanding the pathogenesis of both arterial and venous thrombosis in order to improve the 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 treatment of thrombotic and thromboembolic disorders.

The Branch also supports research on bleeding disorders (e.g., hemophilia and von Willebrand disease) and immune disorders (e.g., idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, and systemic lupus erythematosus). Emerging areas of interest are gene transfer, clinical proteomics, inflammation and thrombosis, stroke, coagulation activation, autoimmune disease, and thrombotic complications of obesity, diabetes, and cancer.

Transfusion Medicine and Cellular Therapeutics Branch

The Transfusion Medicine and Cellular Therapeutics Branch plans and directs research and research training in transfusion medicine, stem cell biology and disease, and clinical cellular medicine. It supports research on the use, safety, and availability of blood and blood components for transfusion and cellular therapies. Research areas include transmission of disease, noninfectious complications of transfusions, immunobiology, cell biology and disease, cell-based therapies, hematopoietic stem cell transplantation, and overall product availability.

The Branch develops programs for basic and clinical research related to normal and abnormal cellular biology and pathology. It also collaborates with governmental, private sector, and international organizations to improve the safety and availability of the global supply of blood and blood components.

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Division of Prevention and Population Sciences

The DPPS supports and provides leadership for population- and clinic-based research on the causes, prevention, and clinical care of cardiovascular, lung, and blood diseases and sleep disorders. Research includes a broad array of epidemiological studies to describe disease and risk factor patterns in populations and to identify risk factors for disease; clinical trials of interventions to prevent disease; studies of genetic, behavioral, sociocultural, and environmental influences on disease risk and outcomes; and studies of the application of prevention and treatment strategies to determine how to improve clinical care and public health. The Division also supports training and career development for these areas of research.

The Division is organized into three major branches:

Clinical Applications and Prevention Branch

The Clinical Applications and Prevention Branch supports, designs, and conducts research, and supports training, on behavioral, environmental, clinical, and health care approaches to reduce occurrence and consequences of CVD. Prevention research examines effects of interventions to slow or halt risk factor or disease development or progression; interventions use high-risk individual and population approaches, including medications, behavioral strategies, and environmental change. Studies examine lifestyle, nutrition and exercise, psychological and sociocultural factors, and environmental and genetic influences relevant to prevention. Clinical application research examines approaches to improve health care delivery and patient outcomes. Studies include clinical and community trials and selected observational studies.

Epidemiology Branch

The Epidemiology Branch supports, designs, and conducts research, and supports training, in the epidemiology of cardiovascular, lung, and blood diseases and sleep disorders. Studies are conducted to identify temporal trends and population patterns in the prevalence, incidence, morbidity, and mortality from the diseases and include single- and multicenter observational epidemiology studies of development, progression, and treatment of cardiovascular, lung, and blood diseases and sleep disorders. Studies identify environmental, lifestyle, physiological, and genetic risk factors for disease and risk factor development including characterization of gene–gene and gene–environment interactions. The Branch also distributes data from all eligible NHLBI studies to researchers as a national data resource and adheres to guidelines that protect participant privacy and confidentiality.

WHI Branch

The WHI Branch supports clinical trials and observational studies to improve the understanding of the causes and prevention of major diseases affecting the health of women. Current studies focus on CVD, cancer, and fractures, in collaboration with National Cancer Institute (NCI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA), National Institute of Neurological Disorders and Stroke (NINDS), and Office of Research on Women’s Health (ORWH). Large, multicenter, observational epidemiology studies seek to identify risk markers for disease or better quantify known markers using questionnaire, clinical examination, and laboratory data. The large and long-term multicenter clinical trials test promising but unproven interventions such as hormone therapy, diet, and supplements to prevent major diseases and evaluate overall effects on health. The Branch has established an infrastructure to support the use of data and blood samples from the studies by the scientific community.

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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 fiscal year (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 (NMR) 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 structure–function relationships 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. The Office also coordinates NHLBI international programs and activities. 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, and sleep disorders. 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.

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 coronary heart disease (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.

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. It employs a number of outreach strategies. Major emphasis is placed on developing, disseminating, and implementing national guidelines on the diagnosis and management of asthma. 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 National Heart Attack Alert Program (NHAAP) was initiated in 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.

The NHLBI Obesity Education Initiative (OEI) was launched in 1991 to reduce the prevalence of overweight, obesity, and physical inactivity in order to lower the risk and overall morbidity and mortality from CHD. In addition, reducing the prevalence of overweight/obesity will help to prevent or improve other diseases and conditions such as type 2 diabetes and sleep apnea.

Because of the association of obesity and physical inactivity with the various risk factors for CVD as well as impaired lung function, the OEI helps to enhance and integrate education activities related to both weight and physical activity. One such program, conducted 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, is “We Can!,” a national public education program designed to address the dramatic increase in overweight and obesity in children. The program targets youth, ages 8–13, and their parents or primary caregivers in home and community settings to help prevent obesity.

The NCSDR works closely with the OPEC on education pertaining to sleep problems and sleep disorders for physicians, other health care providers, and the general public. Reaching children and adolescents with messages about sleep and sleep disorders is a priority. The NCSDR and Garfield the Cat have teamed up to provide sleep education information for kids, parents, teachers, and pediatricians on the Garfield Star Sleeper Web site.

The NHLBI, along with its partner organizations, launched The Heart Truth campaign in 2002 to make women more aware of the danger of heart disease. The campaign, which uses a red dress as a national symbol for women and heart disease awareness, is especially aimed at women ages 40 to 60, the time when a woman’s heart disease risk starts to rise. It also targets women of color because they have high rates of the major risk factors for heart disease, such as obesity, physical inactivity, high blood pressure, and diabetes.

The Institute has undertaken educational activities in peripheral arterial disease, COPD, and von Willebrand disease. A campaign designed to educate the public about the signs and symptoms of peripheral arterial disease and its risk factors and to encourage those at risk to seek diagnosis and treatment was launched on September 19. A COPD awareness and education campaign targeting patients, those at risk, and health care providers will be launched in FY 2007.

The OPEC is also 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. In addition, the Coordinator is the Institute’s representative to other relevant components of the NIH, the U.S. Department of Health and Human Services (HHS), and other components of the Federal Government on nutrition research and policy.

The NHLBI supports several outreach education programs that target blacks and ethnic minorities who are disproportionately affected by heart disease. One such program, “Enhanced Dissemination and Utilization Centers” (EDUCs), focuses on high-risk communities and seeks to eliminate cardiovascular health disparities and improve the health of underserved populations. The “Salud para su Corazón” (Health for Your Heart) initiative is a community-based heart health program for Latinos that uses trained local lay health workers (promotores de salud) applying the values and culture of the community to teach individuals and patients how to reduce their risk of developing CVD. American Indian and Alaska Native (AI/AN) communities and Asian American and Pacific Islanders are additional populations that receive special attention. Programs specifically directed and culturally sensitive emphasize the importance of good heart health.

The NHLBI initiated the “Keep the Beat” program in 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 onsite “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.

In FY 2006, based on a recommendation from participants attending the CVD Thought Leaders meeting, the OPEC is seeking to assemble its CVD education and outreach programs and initiatives into a Cardiovascular Knowledge Network and to establish integrated CVD guidelines that will enable clinicians and patients to address all of the risk factors contributing to CVD risk.

The Institute’s international programs support a number of global activities to promote research, research training, and improved health within its mandate. Activities include providing training in its laboratories to international research fellows from approximately 30 countries; collaborating with the Institute of Circulatory and Respiratory Health, Canadian Institutes of Health Research (CIHR), on cardiovascular, pulmonary, and blood diseases research; conducting epidemiologic, laboratory, and survey research on blood donors in selected developing countries in regions seriously affected by the HIV/AIDS epidemic; and partnering with the Pan American Health Organization (PAHO) and the World Health Organization (WHO) to address the pandemic of CVD in North, Central, and South America and the Caribbean.

The NHLBI supports efforts to encourage collaboration and research on rare diseases. It is working with Ghana to compare the differences in epidemiology and etiology of infections in SCD between Africa and the United States; supporting clinical studies on Cooley’s anemia in the United Kingdom; and initiating research into the genetics and basic mechanisms of Diamond-Blackfan anemia and other rare inherited bone marrow failure syndromes with Australia, Canada, and Sweden.

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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