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:
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:
In 2007, the NHLBI released the Strategic Plan: A Scientific Blueprint for the Next Decade, which is intended to guide the Institute in its research and training programs over the next 5 to 10 years. Its goals reflect the successive movement of scientific discovery from "form to function," "function to causes," and "causes to cures." They focus on questions and processes that are broadly applicable to the Institute's mandate, rather than on any specific disease or condition. The goals are:
During the past year, the Institute continued to restructure its organization to improve the Institute's ability to serve as an international leader through support of innovative research in heart, lung, blood, and sleep research. The reorganization strengthened scientific coordination by seeking specialized depth in specific disease areas, integrating basic research and clinical trials components, emphasizing prevention, and fostering population sciences.
Education outreach was a major area to undergo reorganization. Through the Office of Prevention, Education, and Control (OPEC), the NHLBI has had a long history of establishing and maintaining educational outreach programs to fulfill its Congressional mandate to translate and disseminate science-based information to professional, patient, and public audiences. In an effort to enhance the visibility and effectiveness of this mandated function, the NHLBI Director established the Division for the Application of Research Discoveries (DARD), replacing the OPEC. The DARD provides leadership for the vigorous pursuit of excellence in national and international research translation, dissemination, and utilization programs to speed the application of scientific advances in prevention, detection, and treatment of cardiovascular, lung, and blood diseases and to reduce the discoverydelivery gap. Through knowledge networks, education programs, community outreach, conferences, and symposia, the DARD fosters communication and collaboration among researchers, clinical and public health practitioners, patients, and the general public.
The programs of the NHLBI, as shown on page 9, are implemented through five extramural units:
and one intramural unit:
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 (SCOR) and Specialized Centers of Clinically Oriented Research (SCCOR) grants, comprehensive center grants, contracts, and research training and career development programs.
Descriptions of the Divisions follow.
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 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. SCCORs support clinical collaborative research in cardiac dysfunction and disease; pediatric heart development and disease; and vascular injury, repair, and remodeling.
The Division is organized into the five branches and one 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. The Branch supports the following areas:
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 promotes opportunities to translate promising scientific and technological advances from discovery through preclinical studies to networks and multisite clinical trials. The Branch supports the following areas:
Heart Development and Structural Diseases Branch
The Heart Development and Structural Diseases Branch conducts and manages an integrated basic and clinical research program to study normal and abnormal cardiovascular development. It also oversees research related to the etiology, pathogenesis, prevention, diagnosis, and treatment of pediatric and adult structural heart disease. Within the NHLBI and the NIH, the Branch is a focal point for coordination of activities and development of educational materials related to clinical research on pediatric CVD. It promotes opportunities to translate promising scientific and technological advances from discovery through preclinical studies to network and multisite clinical trials. The Branch supports the following areas:
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. The Branch supports the following areas:
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. The Branch supports the following areas:
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 who are early in their research careers and under mentorship from senior scientists to perform basic, preclinical, or clinical cardiovascular 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 the current and future needs of the cardiovascular research workforce. The Office supports the following programs:
The DLD plans and directs a coordinated research program on the causes, progression, diagnosis, treatment, and prevention of lung diseases and sleep disorders. It supports basic research, clinical trials, national pulmonary centers, technological development, and application of research findings. The Division focuses on 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 and neurobiology of sleep and sleep apnea. SCCORs support collaborative studies on translational research in acute lung injury, COPD, pulmonary vascular disease, and host factors in chronic lung diseases.
The Division also supports (a) demonstration and dissemination projects to transfer basic research and clinical findings to health care professionals and patients and (b) training and career development programs for individuals interested in furthering their professional abilities in lung diseases research. The DLD, through the National Center on Sleep Disorders Research, coordinates sleep research activities across NIH, other Federal Agencies, and outside organizations.
The Division is organized into the three major branches described below.
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 genetics, etiology, and pathophysiology of the diseases. Clinical studies focus on improving asthma management; 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 Branch 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 National Center on Sleep Disorders Research (NCSDR) plans, directs, and supports basic, clinical, and applied research, health education, and training in sleep 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 several Federal Government Agencies and with professional, voluntary, and private organizations. The Center promotes information sharing and coordinates implementation of inter-Agency 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.
The DBDR plans and directs research and research training on the causes, treatment, 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 has 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 diseases, transfusion biology and medicine, SCD, and cell-based therapy for blood diseases. Clinical networks support collaborative clinical research in rare diseases, bone marrow transplantation, and transfusion medicine/hemostasis. The DBDR also has a major responsibility to improve the adequacy and safety of the Nations blood supply.
The Division is organized into the three major branches described below.
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. The Centers conduct basic and collaborative clinical research and provide state-of-the-art patient care, educational activities for patients and health professionals, community outreach, and genetic counseling services.
Clinical networks in thalassemia and SCD are 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 that focuses on understanding the pathogenesis of arterial and venous thrombosis 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.
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 the three major branches described below.
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 factors 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.
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 genegene and geneenvironment 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.
Womens Health Initiative Branch
The Womens Health Initiative 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 of Aging (NIA), National Institute of Neurological Disorders and Stroke (NINDS), and Office of Research on Womens Health (ORWH). Large multicenter observational epidemiology studies seek to identify risk markers for disease or better quantify known markers by using data from questionnaires, clinical examinations, and laboratory analyses. The long-term clinical trials test promising but unproven interventionssuch as hormone therapy, diet, and supplements to prevent major diseasesand 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.
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 developments related to them.
The DIR includes the following four centers and three branches:
Biochemistry and Biophysics Center
The Biochemistry and Biophysics Center develops a global view of the molecular basis of structurefunction 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 structurefunction relationships, elucidates the mechanisms of enzyme function, and investigates the relationship between protein structurefunction 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.
The Immunology Center develops a global view of 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 allergicautoimmune reactions, and relates the results to the development of new diagnostic and therapeutic approaches in humans.
Translational Medicine Branch
The Translational Medicine Branch conducts biomedical research directed at defining at the molecular level, normal and abnormal biologic function. It develops diagnostic and therapeutic modalities for the treatment and understanding of CVD and implements mechanism-based clinical studies centered on innovative discoveries and observations from inside and outside of the 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 and Vascular Medicine Branch
The Pulmonary and Vascular Medicine Branch conducts research on the lung, heart, and systemic vasculature directed at definingat the molecular, biochemical, and functional levelsnormal physiological function and novel mechanisms of disease. It conducts research in emerging diseases of the lung characterized by unknown etiology and molecular pathogenesis. Areas of interest include lung diseases in blacks such as sickle cell lung disease and sarcoidosis; the role of nitric oxide, nitrite, gender, preconditioning and mitochondrial function on the modulation of ischemia and reperfusion injury of the heart and lung; and translational study and drug development for therapeutic modulation of vascular, pulmonary, and cardiac cellular and molecular dysfunction in diseases of the lung and heart.
The DARD 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. Special attention is given to eliminate health disparities among high-risk, low-income, and minority populations.
The Division is organized into the three branches described below.
Research Translation Branch
The Research Translation Branch fosters the rapid translation of emergent knowledge into practice by synthesizing and organizing evidence around priority diseases and conditions and identifies knowledge gaps that need to be addressed by future research. It promotes the use of evidence-based reviews and develops or facilitates the development of clinical guidelines with relevant stakeholders. Additionally, it develops support for clinical decisions and other innovative implementation applications for use in clinical and public health practice settings. Through the use of knowledge networks and other strategies, it enables researchers and users of research to discuss issues of research applicability, relevance, and utility that may offer guidance to future research needs and opportunities.
Enhanced Dissemination and Utilization Branch
The Enhanced Dissemination and Utilization Branch collects, synthesizes, and communicates new knowledge and recommendations for dissemination and utilization of research-based findings to diverse target audiences, including minority and underserved groups. It provides technical assistance and information resources to enhance NHLBI grantees dissemination plans and practices and accelerates the speed with which evidence-based tools and education programs move into community practice settings. Additionally, it establishes community-based Enhanced Dissemination and Utilization Centers committed to applying and evaluating the impact of the latest research advanced in multiple settings to achieve the U.S. Department of Health and Human Services (HHS) Healthy People goals and to eliminate health disparities. The Branch evaluates the effectiveness of its dissemination and utilization activities so that it can apply lessons learned to future programs.
Health Communications and Social Marketing Branch
The Health Communications and Social Marketing Branch supports communication of health information to health care professionals, patients, and the public. Using results of the latest communications and social marketing research, the Branch plans health communications strategies and develops consumer messages and public education campaigns. It develops and maintains media relations and communicates research and educational messages through multiple media channels. In addition, the Branch operates the NHLBI Health Information Center to respond to professional and public inquiries and to develop and market publications and online information to health care providers and the public. The Center also manages NHLBI exhibit programs.