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5. Institute-Initiated Programs Starting in FY 2005

More than two-thirds of the research supported by the NHLBI is initiated by individual investigators; the remainder is initiated by the Institute. Institute-initiated programs are developed in response to evolving national needs, Congressional mandates, and advances in scientific knowledge. Each initiative represents the outcome of extensive discussions and thorough reviews by representatives of the scientific community, Institute advisory committees, the Board of Extramural Advisors (BEA), and the National Heart, Lung, and Blood Advisory Council (NHLBAC). The advisory committees and the BEA, together with professional societies and NHLBI staff, continually review the progress of research within the NHLBI program areas, assess newly acquired knowledge, and identify research topics that offer the best opportunities or constitute the greatest needs. This planning process contributes to policy development at the national level by setting priorities among programs and establishing budgets for individual programs and projects.

Initiatives generally emanate as Requests for Applications (RFAs) for grants, including cooperative agreements, or Requests for Proposals (RFPs) for contracts. A smaller number of initiatives take the form of Program Announcements (PAs). Applications and proposals submitted in response to RFAs and RFPs compete among themselves for specific "set-aside" funds. Applications submitted in response to PAs generally compete with other investigator-initiated applications for funding.

RFA, RFP, and PA concepts prepared by the Institute are presented to the BEA, which reviews and prioritizes them. The concepts, along with the comments from the BEA, are then sent to the NHLBAC for review, comment, and concurrence. Initiatives that receive the concurrence of the NHLBAC are considered further by the NHLBI Director in the context of the Institute's budget, program priorities, review workload, and proposed mechanisms. These considerations guide the Director's subsequent decisions to approve initiatives for release. RFAs, RFPs, and PAs are announced in the weekly publication, the NIH Guide to Grants and Contracts.

Applications and proposals submitted in response to RFAs and RFPs are reviewed by the NHLBI. Applications submitted in response to PAs are reviewed by the NIH Center for Scientific Review.

Descriptions of the Institute-initiated programs that began or were renewed (i.e., were funded) in FY 2005 are presented below according to NHLBI scientific program. Also described are trans-NIH and interagency initiatives in which the NHLBI is participating.

Heart and Vascular Diseases Program

Initiatives Being Renewed

Atherosclerosis Risk in Communities (ARIC) Study

The purpose of this renewal is to assess trends in incidence of myocardial infarction (MI) and heart failure and to continue identification of their risk factors in four diverse communities. Specifically, the study will extend community surveillance of trends in MI incidence through 2009 and beyond age 74, initiate surveillance of heart failure, and continue investigation of new risk factors (e.g., first time reports of carotid intimal-medial thickness predicting CHD and stroke) for CHD and heart failure in the ARIC cohort subjects aged 45-64 at study entry.

Cardiovascular Health Study: Transition Phase

The purpose of this renewal is to enhance the use of data and samples from the Cardiovascular Health Study (CHS) during a transition period from the current contract-funded, NHLBI-directed program to one directed by a steering committee of investigators with independently acquired grants. The goals are to maintain the core coordinating center and laboratory support; continue follow-up of participants for cardiovascular events and maintenance of sample repository; ensure open access to CHS data and specimens for the entire scientific community; and promote innovative use of the resource by new collaborators who will develop independently funded research projects.

Family Blood Pressure Program Extension

The purpose of this renewal is to identify and characterize the genes that contribute to hypertension and related conditions in multiple racial groups. The program will also investigate the pathways through which genetic variation translates into differences in blood pressure levels and risks of hypertension.

Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN) Study

The purpose of this renewal is to identify and map the genes that contribute to CVD in a population of isolated Alaska Natives whose traditional lifestyle is being altered by mechanization and a westernized diet. The population is beginning to show a marked acceleration in the prevalence of atherosclerosis and coronary artery disease.

Strong Heart Study

The purpose of this renewal is to extend support for Phase V of the Strong Heart Study, which is evaluating CVD and its risk factors, especially obesity and type 2 diabetes, in American Indians. Phase V seeks to determine the genetic and environmental contributors of CVD in extended families; continue the mortality and morbidity surveillance of the original cohort along with initiating annual mortality surveillance and limited morbidity follow-up of the noncohort family members; and re-examine family members so that changes in risk factors can be analyzed and genetic effects on changes can be estimated.

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New Initiatives

Community-Responsive Intervention To Reduce Cardiovascular Risk in American Indians and Alaska Natives

The purpose of this cooperative agreement is to evaluate the effectiveness of behavioral interventions such as weight reduction, regular physical activity, and smoking cessation to reduce cardiovascular risk in American Indians and Alaska Natives. Investigators will develop and test culturally appropriate interventions that can be incorporated into clinical programs of the community health care systems or delivered through public-health approaches in Native communities.

Specialized Centers of Clinically Oriented Research in Cardiac Dysfunction and Disease

The purpose of this SCCOR is to improve understanding of the disease process within the myocardium through multidisciplinary research that integrates molecular, structural, mechanical, and electrical elements into a cohesive picture. The goal is to translate research findings into more effective methods of treatment, diagnosis, and prevention of cardiac disorders, including ischemic and other cardiomyopathies, left ventricular dysfunction, metabolic abnormalities, congestive heart failure, and rhythm disturbances. Because some segments of the population suffer from heart disease disproportionately, investigators will emphasize research that addresses issues related to health disparities.

Lung Diseases Program

Initiative Being Renewed

Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)

The purpose of this renewal is to conduct controlled clinical trials of treatments and management practices for acute lung injury and acute respiratory distress syndrome.

New Initiatives

Causes and Mechanisms of COPD Exacerbations

The purpose of this RFA is to investigate the causes of, and the molecular pathways involved in, acute exacerbation of COPD. The goal is to identify specific new targets for more effective preventive and therapeutic interventions.

Idiopathic Pulmonary Fibrosis Clinical Research Network

The purpose of this RFA is to establish a clinical research network to design and perform multiple therapeutic trials in patients with newly diagnosed idiopathic pulmonary fibrosis. The trials will evaluate existing or new medications, combinations of medications, and defined management strategies.

Pathogenesis of SARS Lung Disease: In Vitro Studies and Animal Models

The purpose of this PA is to encourage research that will rapidly advance understanding of the pathogenesis of severe SARS in the lung using in vitro techniques, existing animal models of related coronavirus infections, and appropriate animal models of SARS.

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Blood Diseases and Resources Program

Initiative Being Renewed

Thalassemia Clinical Research Network

The purpose of this renewal is to conduct clinical trials to evaluate existing and new therapies for thalassemia. The network will move effective therapies from the laboratory to the bedside through rapid and systematic collaborative testing in phase II and phase III clinical trials.

New Initiatives

Cellular and Genetic Discovery Toward Curative Therapy in Myeloproliferative Disorders (MPD)

The purpose of this RFA is to stimulate research to discover cellular and genetic markers associated with the origin and progression of MPD. Investigators will ultimately seek to translate research findings into innovative treatments that will cure MPD.

Development of a Health-Related Quality of Life Questionnaire in Sickle Cell Disease

The purpose of this RFP is to develop a quality of life questionnaire and related materials to be used in clinical trials and outcomes research among adults with SCD, and subsequently to assist researchers who choose to use the new products.

Improved Therapy for Hemophilia and Hereditary Bleeding Disorders

The purpose of this RFA is to develop improved therapies, with the goal of finding a cure, for hemophilia and other hereditary bleeding disorders. The focus is on stimulating research to improve therapy, and enhance understanding of immune response and safety issues related to new therapeutics, gene transfer, or cell-based therapies for bleeding disorders. The RFA is cosponsored by the National Hemophilia Foundation.

Myelodysplastic Syndrome: Seeking Cure Through Discovery on Pathogenesis and Disease Progression

The purpose of this RFA is to determine the etiology and pathophysiology of myelodysplastic syndrome. Investigators will ultimately seek to find a cure for the syndrome.

Specialized Centers of Clinically Oriented Research (SCCOR) in Transfusion Biology and Medicine

The purpose of this SCCOR is to foster multidisciplinary research in transfusion biology and medicine that will improve the safety, efficacy, and availability of blood, blood components, and plasma derivatives. Investigators will apply their findings to evaluate the best approaches to provide blood- and bone-marrow-derived components to patients.

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Initiatives Being Renewed

Competing Continuation Awards of SBIR Phase II Grants for Heart, Lung, Blood, and Sleep Disorders

The purpose of this renewal is to support SBIR Phase II awardees in further pursuing development and assessment of devices or conducting preclinical studies of products or devices relevant to the NHLBI mission prior to clinical evaluation and Federal regulatory agency approval.

NHLBI HBCU Research Scientist Award Extension

The purpose of this renewal is to facilitate research capacity building at the four historically black colleges and universities (HBCU) that were awarded the NHLBI Research Scientist Awards in 1996 to conduct biomedical or behavioral research in cardiovascular, lung, or blood health and disease, transfusion medicine, or sleep disorders. The program seeks to increase the number of minority individuals involved in biomedical and behavioral research and to reduce health disparities.

NHLBI Minority Institutional Research Training Program

The purpose of this renewal is to provide full-time research training to graduate, postdoctoral, or health professional students at minority schools for investigative careers in cardiovascular, pulmonary, and blood diseases and sleep disorders.

Programs of Excellence in Gene Therapy for Heart, Lung, and Blood Diseases

The purpose of this renewal is to continue support to the four NHLBI Programs of Excellence in Gene Therapy initiated in FY 2000. The renewal will emphasize preclinical projects to facilitate the translation of gene therapy into clinical studies, clinical studies to test safety and efficacy of gene therapy, National Cores to provide resources and services to NHLBI investigators at no cost, and training positions in clinical projects to train M.D. and Ph.D. scientists in conducting gene therapy clinical trials.

New Initiatives

Bioengineering Approaches to Energy Balance and Obesity

The purpose of this RFA is to encourage engineers, physical scientists, and scientists from other relevant disciplines with expertise in obesity and nutrition to develop and evaluate new technologies, instrumentation, and medical devices to address clinical problems related to energy balance, intake, and expenditure. The goal is to increase the number of useful technologies and tools available to scientists to facilitate research and support behavioral changes to address such problems as weight control and obesity.

NHLBI Clinical Proteomics Programs

The purpose of this RFA is to establish clinical proteomics programs to validate existing and new candidate protein markers that will enable early detection of heart, lung, and blood diseases and sleep disorders. The programs will facilitate validation of protein panels that will not only provide diagnostic and prognostic information, but also mechanistic insight into therapeutic responses and new targets for interventions. In addition, the RFA seeks to establish a high-quality education and skills development program to ensure that scientists develop the expertise needed to address the complex challenges in clinical proteomics.

NHLBI Programs of Excellence in Nanotechnology

The purpose of this RFA is to create multidisciplinary teams capable of developing and applying nanotechnology and nanoscience solutions to the diagnosis and treatment of heart, lung, and blood diseases and sleep disorders.

Pulmonary Complications of Sickle Cell Disease

The purpose of this RFA is to encourage collaborative research between investigators in hematology and pulmonary science that combines basic and clinical approaches. The goals are to translate basic research findings into clinical applications to treat pulmonary complications of SCD and to encourage clinical and basic research on the role of upper airway obstruction and sleep disturbances in acute chest syndrome and other pulmonary complications of SCD.

Specialized Centers for Cell-Based Therapy (SCCT) for Heart, Lung, and Blood Diseases

The purpose of this RFA is to establish SCCT to conduct preclinical and clinical studies on cell-based therapy for treatment of heart, lung, and blood diseases. Investigators will seek to translate basic research findings into clinical applications for treatment of heart, lung, and blood diseases. They will have 1 to 2 years to do preclinical studies to meet the requirements for an Investigational New Drug application prior to initiating clinical studies. By the beginning of the third year, the centers should be ready to initiate clinical studies.

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Initiatives Being Renewed

Jackson Heart Study

The purpose of this renewal is to investigate genetic and environmental causes of CVD in blacks. It also will build research capabilities in minority institutions, address the critical shortage of minority investigators in epidemiology and prevention, and reduce barriers to dissemination and utilization of health information in a minority population.

Phamacogenetics Research Network and Knowledge Base

The purpose of this renewal is to continue support for a network of collaborative groups that are investigating the influence of human genetic variations on the response to drugs and using the information to develop a public pharmacogenetic knowledge base.

New Initiatives

Asthma Exacerbations: Biology and Disease Progression

The purpose of this RFA is to elucidate the mechanisms and consequences of asthma exacerbation; define the pathways that are altered during resolution of exacerbations; and determine their impact on lung function, physiology, and disease state. Research findings will provide the basis for developing more effective treatments that will control symptoms and exacerbations while maintaining or improving lung function.

Bioengineering Research Partnerships

The purpose of this PA is to support multidisciplinary research teams in applying integrative, systems approaches to improve understanding of disease and its diagnosis, treatment, and prevention or to understand health and behavior.

Centers of Excellence in Translational Human Stem Cell Research

The purpose of this RFA is to establish Centers of Excellence in Translational Human Stem Cell Research to accelerate the application of the latest advances in human stem cell biology to the development of diagnostic or therapeutic uses for human disorders. The Centers will bring together basic stem cell biologists and clinicians with disease-specific expertise, physicians and surgeons skilled in new modes of cell delivery, and investigators experienced in developing and assessing animal models of human diseases to create new interdisciplinary research teams and to conduct preclinical studies for cell-based therapy.

Prevention and Treatment of Childhood Obesity in Primary Care Settings

The purpose of this RFA is to test, in a primary care setting, interventions to prevent excessive weight gain in children at risk for obesity and to prevent further weight gain or to promote weight loss in those who are already obese. Interventions will focus on improving dietary and physical activity behaviors.

Mentored Scientist Development Award in Research Ethics (K01)

The purpose of this PAR is to support research ethics training in biomedical, behavioral, or public health research, particularly research involving human participants, by health professionals working at academic and other health-related institutions. The candidate must identify a mentor with extensive research and academic experience in ethical issues related to biomedical research.

Molecular Screening Assay Development for Sickle Cell Disease

The purpose of this RFA is to support the development and adaptation of biological assays for automated, high throughput screening of compounds that can potentially be used to improve the understanding of the biology of SCD and lead to new agents for treatment.

Midcareer Investigator Award in Patient-Oriented Research (K24)

The purpose of this PA is to encourage established, midcareer clinician scientists to devote more time to patient-oriented research and to act as research mentors for beginning clinical investigators.

Salt Sensitivity Diagnostic Test

The purpose of this PA is to stimulate research focused on developing a noninvasive or minimally invasive, rapid, and practical diagnostic test for salt sensitivity of blood pressure in patients during routine physical examination. Ideally, the test should correlate with the long-term changes with blood pressure resulting from high salt intake.

School-Based Intervention To Prevent Obesity

The purpose of this PA is to encourage partnerships between academic institutions and school systems to develop and evaluate behavioral interventions designed to increase children's physical activity and decrease the amount of time that they devote to sedentary activities such as watching television or playing computer games.

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New Initiatives

Characterization of Genetic Variants of HIV and Other Blood-Borne Viruses

The purpose of this initiative is to characterize emerging genetic variants of HIV and other agents transmitted by blood transfusion and to determine their effect on the performance of licensed tests used to screen donated blood.

Development of Serological Assays To Distinguish Incident HIV Infections in Vaccine Recipients Developing HIV Antibodies During Field Tests

The purpose of this initiative is to develop an enzymatic immunoassay for the differential diagnosis of HIV-1 infection in the presence of HIV vaccine- generated antibodies. The project is predicated on the need to distinguish true HIV infections from vaccine-induced antibody responses in populations receiving newly formulated complex HIV vaccines.

Mechanical Circulatory Support for End-Stage Heart Failure: Interagency Registry

The purpose of this RFP is to establish a data and clinical coordinating center to manage a registry of patients receiving a mechanical circulatory support device to treat heart failure. The registry will chronicle device implantation procedures, indications, and outcomes; identify complications and risk factors for complications; develop predictive outcome models; provide blood and tissue for genomic and proteomic investigations; generate evidence to permit better device development, patient selection, and operating procedures; and generate hypotheses for clinical trials and studies that will improve clinical outcomes.


New Initiative

Understanding and Promoting Health Literacy

The purpose of this PA is to increase scientific understanding of the nature of health literacy and its relationship to healthy behaviors, illness prevention and treatment, chronic disease management, health disparities, risk assessment of environmental factors, and health outcomes. Such knowledge will enable health care and public health systems to serve individuals and populations more effectively and to employ strategies that reduce health disparities in the population.

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