« Factbook Table of Contents

9. Research Grants

• NHLBI Total Research Grants by Category
• NHLBI Research Project Grant, Research Centers Grant, and Other Research Grant Obligations: Fiscal Years 1995–2005
• NHLBI Competing Research Project Grant Applications: Fiscal Years 1995–2005
  • Total Cost Dollars Reviewed and Awarded
  • Number Reviewed and Awarded
  • Percent of Reviewed Applications Funded (Success Rate)
• NHLBI Investigator-Initiated and Institute-Initiated Grant Obligations: Fiscal Years 1995–2005
• NHLBI Research Project Grants: Average Costs, Fiscal Years 1995–2005

NHLBI Research Grants by Funding Mechanism: Fiscal Year 2005

NHLBI Total Research Grants by Category

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NHLBI Research Project Grant,* Research Centers Grant, and Other Research Grant Obligations: Fiscal Years 1995–2005

Text-only with data points are represented in the table below.

NHLBI Research Project Grant,* Research Centers Grant, and Other Research Grant Obligations: Fiscal Years 1995–2005

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NHLBI Competing Research Project Grant Applications*: Fiscal Years 1995–2005

Total Cost Dollars Reviewed and Awarded

Text-only with data points are represented in the table below.

NHLBI Competing Research Project Grant Applications: Fiscal Years 1995–2005

Total Cost Dollars Reviewed and Awarded

NHLBI Competing Research Project Grant Applications*: Fiscal Years 1995–2005

Number Reviewed and Awarded

Text-only with data points are represented in the table below.

Percent of Reviewed Applications Funded (Success Rate)

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NHLBI Investigator-Initiated and Institute-Initiated Grant Obligations: Fiscal Years 1995–2005

Text-only with data points are represented in the table below.

NHLBI Investigator-Initiated and Institute-Initiated Grant Obligations: Fiscal Years 1995–2005

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NHLBI Research Project Grants*: Amount Funded by Type of Award, Fiscal Years 1995–2005

Facility and Administrative (F&A)* Costs of NHLBI Research Project Grants†: Fiscal Years 1995–2005

NHLBI Research Project Grants*: Average Costs, Fiscal Years 1995–2005

Text-only with data points are represented in the table below.

NHLBI Research Project Grants*: Average Costs, Fiscal Years 1995–2005

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NHLBI Cooperative Agreements (U01, U10) Programs

Cooperative Agreements were instituted to support discrete, circumscribed projects in areas of an investigator’s specific interest and competency with substantial programmatic participation by the NHLBI during performance of the activity.

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Heart and Vascular Diseases Program

AIM HIGH: Niacin Plus Statin To Prevent Vascular Events, Initiated in Fiscal Year 2005

The purpose of this multicenter clinical trial is to determine whether extended-release niacin plus simvastatin is superior to simvastatin alone for preventing or delaying a major CVD event in patients with atherogenic dyslipidemia. Niacin is used to raise HDL (“good”) cholesterol and simvastatin is used to lower LDL (“bad”) cholesterol. Twenty-seven percent of the population will be black.

Obligations

Funding History:
   Fiscal Year 2005—$663,376
Total Funding to Date—$663,376

Current Active Organizations and Grant Numbers

1. University of Washington
   Seattle, Washington—HL-081616
2. AXIO Research, LLC
   Seattle, Washington—HL-081649

Atherosclerosis, Plaque, and CVD in Communities, Initiated in Fiscal Year 2004

The purpose of this study is to identify correlates of atherosclerotic plaque characteristics and early changes in the vascular wall in a subset of the biethnic Atherosclerosis Risk in Communities (ARIC) cohort. Investigators will use stored DNA samples to test genomic correlates of plaque characteristics and their ability to predict coronary heart disease and stroke.

Obligations

Funding History:
   Fiscal Year 2005—$5,145,549
   Fiscal Year 2004—$4,099,685
Total Funding to Date—$9,245,234

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Bypass Angioplasty Revascularization Investigation in Type 2 Diabetics (BARI 2D), Initiated in Fiscal Year 2000

The purpose of this trial is to compare alternative treatment strategies for managing type 2 diabetic patients with angiographically proven coronary artery disease and stable angina or ischemia. Revascularization combined with aggressive medical anti-ischemia treatment will be compared to aggressive medical anti-ischemia treatment alone; simultaneously, researchers will determine whether insulin-sensitizing drugs like metformin and the glitazones for controlling blood sugar level offer any survival advantage over drugs that increase insulin level. Twenty percent of the patients are from minority populations.

Obligations

Funding History:
   Fiscal Year 2005—$8,304,235
   Fiscal Years 2000–2004—$35,553,973
Total Funding to Date—$43,854,208

Cardiovascular Heart Study (CHS) Events Follow-Up Study, Initiated in Fiscal Year 2005

The purpose of this project is to enhance the use of data and samples from the 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. During the follow-up, many of the initial exam components will be repeated and CVD events will be recorded. The data and specimens collected in CHS represent a major national resource for the study of health, aging, and CVD in older adults. Seventeen percent of the participants are from minority populations.

Obligations

Funding History:
   Fiscal Year 2005—$1,007,645
Total Funding to Date—$1,007,645

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Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL), Initiated in Fiscal Year 2004

The purpose of this trial is to determine whether revascularization of a stenotic renal artery plus medical therapy is associated with improved clinical outcomes compared with medical therapy alone. Thirty percent of the participants will be black.

Obligations

Funding History:Fiscal Year 2005—$5,610,035
   Fiscal Year 2004—$4,343,389
Total Funding to Date—$9,953,424

Center for Fetal Monkey Gene Transfer for Heart, Lung, and Blood Diseases, Initiated in Fiscal Year 2001

The purpose of this Center is to provide expertise, sources, and resources to NHLBI-supported investigators who wish to evaluate viral and nonviral gene transfer strategies in nonhuman primates.

Obligations

Funding History:
   Fiscal Year 2005—$596,406
   Fiscal Years 2001–2004—$2,827,101
Total Funding to Date—$3,423,507

Claudication Exercise vs. Edoluminal Revascularization, Initiated in Fiscal Year 2005

The purpose of this study is to test the hypothesis that a strategy of aortoiliac stenting and pharmacotherapy improves maximum walking duration better than a strategy of supervised rehabilitation, exercise, and pharmacotherapy for those with aortoiliac artery obstruction at 6 months. Other objectives are to compare the two treatment groups with a third group, usual care and pharmacotherapy, at 6 months, and to compare maximum walking duration change scores at 18 months, changes in free living daily activity levels, and patient-perceived quality of life among all three groups.

Obligations

Funding History:
   Fiscal Year 2005—$1,368,413
Total Funding to Date—$1,368,413

Coronary Revascularization in Diabetic Patients, Initiated in Fiscal Year 2004

The purpose of this clinical trial is to compare a multivessel stenting strategy using the Sirolimus-eluting stents with CABG in diabetic patients with multivessel disease. The primary outcome is the difference in mortality rates between the stent group and the CABG group during a 5-year period.

Obligations

Funding History:
   Fiscal Year 2005—$4,669,362
   Fiscal Year 2004—$3,663,095
Total Funding to Date—$8,332,457

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Dynamic Evaluation of Percutaneous Coronary Intervention, Initiated in Fiscal Year 1997

This program, which complements prior NHLBI percutaneous transluminal coronary angioplasty (PTCA) registries and the New Approaches to Coronary Intervention Registry, is evaluating patterns of device usage, as well as immediate and follow-up outcomes in patients undergoing percutaneous transluminal coronary revascularization. Results will provide guidance to the cardiology community in selecting appropriate therapies and in designing clinical trials to evaluate competing devices.

Obligations

Funding History:
   Fiscal Year 2005—$741,144
   Fiscal Years 1997–2004—$4,714,221
Total Funding to Date—$5,455,365

Family Blood Pressure Program, Initiated in Fiscal Year 1995

The objectives of this program are to identify major genes associated with high blood pressure and to investigate the interactions between genetic and environmental determinants of hypertension in defined populations, many of which consist of specific minority groups. The study consists of collaborative networks that share technology, data, skills, biological materials, and population resources.

Obligations

Funding History:
   Fiscal Year 2005—$3,655,901
   Fiscal Years 1995–2004—$84,838,159
Total Funding to Date—$88,494,060

Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN), Initiated in Fiscal Year 2000

The purpose of this study is to document CVD and CVD risk factors in approximately 40 extended families (1,214 members from villages in Northern Alaska). Scientists seek to identify and characterize genes that contribute to CVD in this unique and understudied population.

Obligations

Funding History:
   Fiscal Year 2005—$1,920,380
   Fiscal Years 2000–2004—$7,871,675
Total Funding to Date—$9,792,055

Girls Health Enrichment Multisite Studies (GEMS), Initiated in Fiscal Year 1999

The objective of this project is to develop and test interventions to prevent obesity by decreasing weight gain during the high-risk transitional period from pre-puberty to puberty in black girls who are at risk for developing obesity. Phase 1 (developmental and pilot studies) was completed in FY 2002. Two sites began Phase 2 trials in FY 2003.

Obligations

Funding History:
   Fiscal Year 2005—$2,369,517
   Fiscal Years 1999–2004—$15,098,492
Total Funding to Date—$17,468,009

Heart Failure: A Controlled Trial Investigating Outcomes of Exercise (HF-ACTION), Initiated in Fiscal Year 2002

The purpose of this trial is to determine the long-term safety and effectiveness of exercise training for patients with heart failure. Patients receiving the exercise regimen also will receive standard care and will be compared with patients receiving standard care alone.

Obligations

Funding History:
   Fiscal Year 2005—$4,483,140
   Fiscal Years 2002–2004—$25,044,553
Total Funding to Date—$29,527,693

Home Automatic External Defibrillator Trial (HAT), Initiated in Fiscal Year 2002

The purpose of this trial is to compare standard response (call 9–1–1 and give cardiopulmonary resuscitation) to sudden cardiac arrest to standard response augmented with automatic external defibrillator use provided by a spouse or other family member in 7,000 survivors of an anterior wall MI. The primary end point is mortality.

Obligations

Funding History:
   Fiscal Year 2005—$1,800,742
   Fiscal Years 2002–2004—$13,263,642
Total Funding to Date—$15,064,384

IMMEDIATE Trial: Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care, Initiated in Fiscal Year 2004

The purpose of this program is to study the effects of early administration of glucose, insulin, and potassium (GIK) in reducing mortality in patients from acute coronary syndrome (ACS). Patients experiencing an ACS (including acute MI and unstable angina pectoris) will be treated with GIK as soon as possible in prehospital emergency medical service settings or immediately upon arrival for those presenting to emergency departments.

Obligations

Funding History:
   Fiscal Year 2005—$9,513,736
   Fiscal Year 2004—$5,170,411
Total Funding to Date—$14,684,147

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Interaction of Genes and Environment in Shaping Risk Factors for Heart, Lung, and Blood Diseases and Sleep Disorders, Initiated in Fiscal Year 2002

The purpose of this study is to identify novel genes that interact with specific environmental exposures to modify risk factors for heart, lung, and blood diseases and sleep disorders. The genetic aspects of response to environmental change and related biological mechanisms will be studied using short-term, focused interventions in families. Subgroups will be identified based on genotypes that are most likely to benefit from targeted environmental changes designed to reduce the development or progression of heart, lung, and blood diseases or sleep disorders.

Obligations

Funding History:
   Fiscal Year 2005—$10,547,590
   Fiscal Years 2002–2004—$35,525,298
Total Funding to Date—$46,072,888

Multidisciplinary Study of Right Ventricular Dysplasia, Initiated in Fiscal Year 2001

The purpose of this multidisciplinary, multicenter study is to investigate the cardiac, clinical, and genetic aspects of arrhythmogenic right ventricular dysplasia (ARVD). A North American ARVD registry of patients and their families will be established. Researchers seek to identify chromosomal loci and specific genetic mutations associated with this disorder.

Obligations

Funding History:
   Fiscal Year 2005—$1,195,224
   Fiscal Years 2001–2004—$6,252,319
Total Funding to Date—$7,447,543

NHLBI Clinical Proteomics Program, Initiated in Fiscal Year 2005

The purpose of this program is to promote systematic, comprehensive, large-scale validation of existing and new candidate protein markers that are appropriate for routine use in the diagnosis and management of heart, lung, and blood diseases and sleep disorders. The Program will facilitate validation of protein panels that may be used to predict disease susceptibility or to assist in differential diagnosis, disease staging, selection of individualized therapies, or monitoring of treatment responses. It will also establish a high-quality education and skills development program to ensure that scientists develop the expertise needed to address the complex, multifaceted challenges in clinical proteomics.

Obligations

Funding History:
   Fiscal Year 2005—$5,103,660
Total Funding to Date—$5,103,660

Partnership Programs To Reduce Cardiovascular Health Disparities, Initiated in Fiscal Year 2004

The objectives of this study are to improve the provider and patient approaches to treatment of hypertension and diabetes, modify physician-related barriers to minority enrollment in clinical trials, improve patient adherence to treatment plans, and build sustainable research programs at minority-serving institutions.

Obligations

Funding History:
   Fiscal Year 2005—$7,202,208
   Fiscal Year 2004—$6,468,544
Total Funding to Date—$13,670,752

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Pediatric Cardiovascular Clinical Research Network, Initiated in Fiscal Year 2001

See Chapter 11. Clinical Trials.

Pharmacogenetics Research Network, Initiated in Fiscal Year 2001

The purpose of this study is to establish a network to systematically evaluate candidate genes that may influence pharmacologic response to drug treatments for arrhythmia, heart failure, hypertension, and lipid disorders. Investigators seek to identify gene polymorphisms capable of predicting drug toxicity and efficacy. One of the projects has 50 percent minority participation.

Obligations

Funding History:
   Fiscal Year 2005—$6,334,303
   Fiscal Years 2001–2004—$33,206,897
Total Funding to Date—$39,541,200

Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST), Initiated in Fiscal Year 2003

The purpose of this study is to compare the effects of four diets low in saturated fat and differing in macronutrient composition on weight loss and its maintenance in 800 overweight or obese adults. The diet consists of moderate fat (40 percent energy) or low fat (20 percent energy) with two different protein levels (15 and 25 percent). Approximately 20 percent of the participants will be minority.

Obligations

Funding History:
   Fiscal Year 2005—$2,017,478
   Fiscal Years 2003–2004—$2,899,312
Total Funding to Date—$4,916,790

Primordial Prevention of Overweight in American Indian Children, Initiated in Fiscal Year 2005

The purpose of this study is to prevent early childhood overweight in American Indian children. A cohort of children born over an 18-month period will be randomized to either a control or intervention condition. The intervention comprises a community-wide intervention coupled with individualized family counseling to improve nutrition and physical activity in infants and toddlers. A central feature of the project is to 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.

Obligations

Funding History:
   Fiscal Year 2005—$354,427
Total Funding to Date—$354,427

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Programs of Excellence in Gene Therapy, Initiated in Fiscal Year 2000

The objective of these programs is to create an environment that will enable rapid translation of preclinical studies in cardiovascular, pulmonary, and hematologic diseases into human pilot experiments. In addition, the programs are offering training at the interface between basic science and clinical application. Six national cores provide access to specialized services, such as generating vectors for clinical use, performing morphologically based studies, producing and processing hematopoietic stem cells, and performing primate transplantation studies.

Obligations

Funding History:
   Fiscal Year 2005—$10,803,812
   Fiscal Years 2000–2004—$61,140,050
Total Funding to Date—$71,943,862

Programs of Excellence in Nanotechnology, Initiated in Fiscal Year 2005

The purpose of this program is to establish multidisciplinary teams to develp nanotechnology and biomolecular engineering tools and methodologies to detect and analyze atherosclerotic plaque formation. The program presents an unique opportunity for research collaboration and skills training by bring bioengineering and nanotechnology solutions into medicine and vice versa.

Obligations

Funding History:
   Fiscal Year 2005—$6,322,873
Total Funding to Date—$6,322,873

Programs of Genomic Applications (PGAs) for Heart, Lung, and Blood Diseases, Initiated in Fiscal Year 2000

The goal of this program is to develop information, tools, and resources to link genes to biological function. Specifically, researchers seek to identify human genes relevant to heart, lung, blood, and sleep functions. In addition, the PGAs will establish training programs for NHLBI-supported investigators in the use of genomic information and technologies.

Obligations

Funding History:
   Fiscal Year 2005—$14,858,305
   Fiscal Years 2000–2004—$165,782,192
Total Funding to Date—$180,640,497

Resuscitation Outcome Improvement Consortium, Initiated in Fiscal Year 2004

The purpose of this program is to establish a resuscitation research consortium to conduct clinical research in the areas of cardiopulmonary arrest and traumatic injury leading to arrest. The consortium will enable investigators to conduct multiple collaborative trials to expedite the translation of promising scientific and clinical advances to improve resuscitation outcomes.

Obligations

Funding History:
   Fiscal Year 2005—$9,338,606
   Fiscal Year 2004—$6,886,109
Total Funding to Date—$16,224,715

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Stop Atherosclerosis in Native Diabetics Study (SANDS), Initiated in Fiscal Year 2002

This study will address the high incidence of cardiovascular disease in a population with a high prevalence of diabetes, but relatively low levels of LDL cholesterol and blood pressure. It will compare aggressive lowering of LDL cholesterol and blood pressure to the usual care standard.

Obligations

Funding History:
   Fiscal Year 2005—$2,323,642
   Fiscal Years 2002–2004—$6,681,337
Total Funding to Date—$9,004,979

Strong Heart Study, Initiated in Fiscal Year 1988

The objectives of this study are to survey CVD morbidity and mortality rates among three geographically diverse groups of American Indians and to estimate their levels of CVD risk factors. Phases II and III of the cohort study extended surveillance of community mortality and assessed development of CVD and changes in CVD risk factors. In Phase III, investigators added a substudy of asthma and a pilot family study. The purpose of Phase IV is to enlarge the family study to 120 families comprising 3,600 members to investigate genetic and environmental contributors of CVD.

Obligations

Funding History:
   Fiscal Year 2005—$5,300,000
   Fiscal Years 1988–2004—$46,438,304
Total Funding to Date—$51,738,304

Surgical Treatment for Ischemic Heart Failure (STICH), Initiated in Fiscal Year 2002

The purpose of this clinical trial is to determine whether CABG plus intensive medical therapy improves long-term survival of patients with heart failure and left ventricular (LV) dysfunction who have coronary artery disease amenable to surgical revascularization, compared to medical therapy alone; and to determine whether CABG plus surgical ventricular restoration to a more normal LV size improves survival free of subsequent hospitalizations of patients with anterior LV dysfunction, compared to CABG alone.

Obligations:

Funding History:
   Fiscal Year 2005—$6,082,190
   Fiscal Years 2002–2004—$13,864,647
Total Funding to Date—$19,946,837

Trial of Activity for Adolescent Girls (TAAG), Initiated in Fiscal Year 2000

See Chapter 11. Clinical Trials.

Weight Loss Maintenance (WLM), Initiated in Fiscal Year 2003

The purpose of this multicenter trial is to evaluate the effectiveness of two strategies to maintain weight loss for 2½ years in approximately 800 overweight or obese adults. Individuals who are taking medication for hypertension of dyslipidemia or who are diabetic enter a 6-month weight program. Those who lose at least 9 pounds are randomized into one of three groups: one that provides monthly personal contacts with a trained interventionist, primarily by telephone; one that provides frequent contacts through an interactive Web-based program; or usual care. Forty percent of the participants will be black.

Obligations

Funding History:
   Fiscal Year 2005—$3,098,894
   Fiscal Years 2003–2004—$8,054,488
Total Funding to Date—$11,153,382

Women’s Ischemia Syndrome Evaluation (WISE), Initiated in Fiscal Year 2001

The purpose of this study is to extend the follow-up of WISE patients to determine the incremental long-term prognostic value of novel testing developed in WISE, develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables, and maintain a WISE database and infrastructure to facilitate further investigations into the mechanisms underlying ischemic syndromes in women.

Obligations

Funding History:
   Fiscal Year 2005—$995,753
   Fiscal Years 2001–2004—$5,617,360
Total Funding to Date—$6,613,113

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Lung Diseases Program

Asthma Clinical Research Network (ACRN) Phase II, Initiated in Fiscal Year 2003

See Chapter 11. Clinical Trials.

Centers for Reducing Asthma Disparities, Initiated in Fiscal Year 2002

The purpose of this study is to establish cooperative centers of research to reduce asthma disparities between whites and minorities and economically disadvantaged populations. The mission of the centers, comprising partnerships between minority-servicing medical institutions and research-intensive institutions, is to promote interdisciplinary investigation of factors that contribute to disparities in asthma, accelerate development and evaluation of strategies to promote effective asthma management among minority and economically disadvantaged populations, encourage training and career development for minority clinical research investigators, and improve the effectiveness of NHLBI-supported research-intensive institutions in developing and sustaining culturally appropriate research and demonstration activities on reducing disparities.

Obligations

Funding History:
   Fiscal Year 2005—$5,135,604
   Fiscal Years 2002–2004—$17,269,191
Total Funding to Date—$22,404,795

Childhood Asthma Management Program–Continuation Study (CAMP–CS)/Phase 2, Initiated in Fiscal Year 2003

The objectives of this observational study are to follow the original CAMP cohort for 4 more years into early adulthood to determine the effects of long-term (3.5 to 5.5 years) corticosteroid therapy, started at ages 5 to 12, on outcomes of pulmonary function, height, bone density, and clinical course of asthma; 31 percent of the participants are from minority groups.

Obligations

Funding History:
   Fiscal Year 2005—$2,622,721
   Fiscal Years 2003–2004—$3,532,802
Total Funding to Date—$6,155,523

Childhood Asthma Research and Education (CARE) Network, Initiated in Fiscal Year 1999

See Chapter 11. Clinical Trials.

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Collaborative Program in Bronchopulmonary Dysplasia, Initiated in Fiscal Year 1999

The objectives of this program are to support a multi-institutional collaborative research effort by providing a well-defined model of prematurity and bronchopulmonary dysplasia to investigators, and to study mechanisms of lung pathobiology that underlie development of chronic lung disease of prematurity.

Obligations

Funding History:
   Fiscal Year 2005—$5,353,412
   Fiscal Years 1999–2004—$26,302,593
Total Funding to Date—$31,656,005

COPD Clinical Research Network, Initiated in Fiscal Year 2003

See Chapter 11. Clinical Trials.

Early Antipseudomonal Therapy in Cystic Fibrosis, Initiated in Fiscal Year 2004

The purpose of this study is to determine a safe, effective, and systematic approach for treating young children (ages 1 to 12 years) with cystic fibrosis who are found to be infected with Pseudomonas aemginosa (Pa). The goal is to intervene with antipseudomonal therapy at the first isolation of Pa to delay or prevent chronic infections that lead to irreversible lung destruction.

Obligations

Funding History:
   Fiscal Year 2005—$1,047,381
   Fiscal Year 2004—$1,064,237
Total Funding to Date—$2,111,618

Idiopathic Pulmonary Fibrosis Clinical Research Network, Initiated in Fiscal Year 2005

See Chapter 11. Clinical Trials.

Pharmacogenetics of Asthma Treatment, Initiated in Fiscal Year 2000

The objective of this project is to bring together research experts in asthma, epidemiology, statistics, bioinformatics, physiology, clinical trials, genetics, and genomics to focus on the pharmacogenetics of asthma treatment.

Obligations

Funding History:
   Fiscal Year 2005—$3,361,644
   Fiscal Years 2000–2004—$10,847,376
Total Funding to Date—$14,209,020

Prospective Investigation of Pulmonary Embolism Diagnosis-III (PIOPED III), Initiated in Fiscal Year 2005

The purpose of this study is to determine the diagnostic accuracy of gadolinium-enhanced magnetic resonance angiography of the pulmonary arteries in combination with magnetic resonance venography of the lower extremities for the detection of acute venous thromboembolic disease.

Obligations

Funding History:
   Fiscal Year 2005—$2,301,770
Total Funding to Date—$2,301,770

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Blood Diseases and Resources

Blood and Marrow Transplant Clinical Research Network, Initiated in Fiscal Year 2001

See Chapter 11. Clinical Trials.

Center for Human Cell Therapy, Initiated in Fiscal Year 2004

The purpose of this Center is to serve as a unique resource to facilitate the development of new cellular therapies for a wide range of human diseases, especially heart, lung, and blood diseases and sleep disorders.

Obligations

Funding History:
   Fiscal Year 2005—$2,352,572
   Fiscal Year 2004—$2,827,171
Total Funding to Date—$5,179,743

Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS), Initiated in Fiscal Year 2003

The purpose of this trial is to test whether a more aggressive transfusion strategy that maintains postoperative Hgb levels above 10 g/dl improves functional outcome in cardiovascular patients who are over age 50 and undergoing surgical hip fracture surgery compared to a more conservative strategy that withholds blood transfusion until the patient develops symptoms of anemia.

Obligations

Funding History:
   Fiscal Year 2005—$2,922,730
   Fiscal Years 2003–2004—$3,435,202
Total Funding to Date—$6,357,932

Genotypic Determinants of Aspirin Response in High Risk Families, Initiated in Fiscal Year 2002

The purpose of this study is to identify genes that may modify aspirin’s effect on platelet function and inflammatory biomarker levels in families at increased risk for premature coronary artery disease.

Obligations

Funding History:
   Fiscal Year 2005—$3,307,112
   Fiscal Years 2002–2004—$8,751,227
Total Funding to Date—$12,058,339

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Stroke With Transfusions Changing to Hydroxyurea, Initiated in Fiscal Year 2005

The purpose of this phase III clinical trial is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia. Additional objectives include comparisons of growth and development, frequency of nonstroke neurological and other sickle-related events, and quality of life. The patient population will be black.

Obligations

Funding History:
   Fiscal Year 2005—$3,345,345
Total Funding to Date—$3,345,345

Thalassemia (Cooley’s Anemia) Clinical Research Network

See Chapter 11. Clinical Trials.

Transfusion Medicine/Hemostasis Clinical Research Network, Initiated in Fiscal Year 2002

See Chapter 11. Clinical Trials.

National Center on Sleep Disorders Research

Apnea Positive Pressure Long-Term Efficacy Study (APPLES), Initiated in Fiscal Year 2002

The purpose of this study is to evaluate the effectiveness of continuous positive airway pressure (CPAP) therapy to provide significant, stable, and long-term neurocognitive or other benefits to patients with obstructive sleep apnea (OSA). Investigators will identify specific neurocognitive deficits associated with OSA and determine which ones are reversible and most sensitive to the effects of CPAP therapy.

Obligations

Funding History:
   Fiscal Year 2005—$3,188,172
   Fiscal Years 2002–2004—$9,354,009
Total Funding to Date—$12,542,181

Sleep Heart Health Study, Initiated in Fiscal Year 1999

The purpose of this multicenter observational study is to determine the degree to which sleep apnea is an independent or contributing risk factor for the development of cardiovascular or cerebrovascular disease.

Obligations

Funding History:
   Fiscal Year 2005—$1,494,336
   Fiscal Years 1999–2004—$18,109,357
Total Funding to Date—$19,603,693

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NHLBI Research Centers (P50, U54, P30) Programs

Specialized Centers of Research (P50) and Specialized Centers of Clinically Oriented Research (P50) Programs

The NHLBI initiated the Specialized Centers of Research (SCOR) program in 1971 to encourage translational research—converting basic science findings to the clinic—in high priority areas. The SCOR concept emphasizes multidisciplinary research (i.e., basic science and clinical investigations) on diseases relevant to the Institute’s mission. In 2002, the NHLBI revised the SCOR program—primarily on recommendation from the NHLBAC—to place more emphasis on clinical research projects. The newly developed SCCOR program still requires clinical and basic scientists to work together on a unified theme, but now requires at least 50 percent of the projects to be clinical. Listed below is the funding history for the individual SCORs/SCCORs supported by the Institute.

Heart and Vascular Diseases Program

Cardiac Dysfunction and Disease

The purpose of this SCCOR is to foster multidisciplinary research on clinically relevant questions related to dysfunction and disease of the myocardium. The program will enable rapid application of basic science findings to the prevention, diagnosis, and treatment of cardiac disorders, including ischemic and other cardiomyopathies, left ventricular dysfunction, metabolic abnormalities, heart failure, and rhythm disturbances. Because some segments of the population disproportionately suffer from heart disease, research that addresses issues of health disparity will be emphasized.

Obligations

Fiscal Year 2005—$16,497,136

Molecular Genetics of Hypertension

The purpose of this SCOR is to elucidate the etiology and pathogenesis of hypertension and to translate the knowledge into improved diagnosis and management of the disease.

Obligations

Fiscal Year 2005—$10,285,182

Molecular Medicine and Atherosclerosis

The goal of this SCOR is to advance understanding of the etiology and pathobiology of the atherosclerotic lesion at the molecular level through modern methods and approaches of molecular medicine. Some of the subprojects have a large minority patient population.

Obligations

Fiscal Year 2005—$8,251,334

Pediatric Heart Development and Disease

The purpose of this SCCOR is to foster multidisciplinary collaborations so that basic research advances can be translated rapidly to clinical care for children with heart disease. Research focus ranges from the genetic basis of heart valve disease to clinical trials of novel surgical strategies for congenital heart disease repair and immune modulation in pediatric heart transplantation. Two of the centers will have Clinical Research Skills Development Cores to train fellows and junior faculty in clinical research methods.

Obligations

Fiscal Year 2005—$13,282,825

Lung Diseases Program

Airway Biology and Pathogenesis of Cystic Fibrosis

The goals of this SCOR are to investigate the basic mechanisms underlying cystic fibrosis, develop new hypotheses, and apply innovative strategies for approaching clinical and fundamental issues.

Obligations

Fiscal Year 2005—$3,615,257

Cellular and Molecular Mechanisms of Asthma

The objective of this SCOR is to apply critical science and technology to increase understanding of cellular and molecular mechanisms of asthma, including those mechanisms underlying the biological impact of environmental factors.

Obligations

Fiscal Year 2005—$15,501,156

Pathobiology of Fibrotic Lung Disease

The purpose of this SCOR is to study cellular and molecular mechanisms involved in transition from inflammatory events associated with early fibrotic disease to later processes involving wound healing, repair, and fibrosis.

Obligations

Fiscal Year 2005—$5,427,833

Pathobiology of Lung Development

The objective of this SCOR is to foster multidisciplinary research enabling basic science findings to be rapidly applied to clinical problems related to lung development. The program focuses on identification of the molecular variables involved in lung development and assessment of the impact of injury during critical periods.

Obligations

Fiscal Year 2005—$7,584,895

Translational Research in Acute Lung Injury

The purpose of this SCCOR is to foster multidisciplinary research to improve the prevention, diagnosis, and treatment of acute lung injury and its more severe form—adult respiratory distress syndrome. This program includes phase II clinical trials and studies of molecular mechanisms of inflammation and coagulation, gene and protein expression, and cell and animal models of lung injury.

Obligations

Fiscal Year 2005—$12,305,723

Blood Diseases and Resources Program

Hemostatic and Thrombotic Disorders

The purpose of this SCOR is to investigate pathogenic mechanisms involved in human thrombotic disease and to develop improved methods for its diagnosis and treatment. One of the studies has a large minority patient population.

Obligations

Fiscal Year 2005—$7,543,875

Transfusion Biology and Medicine

The purpose of this SCOR is to foster new approaches for improving the availability, efficacy, safety, and quality of blood and blood products for therapeutic uses. One of the centers has a large minority population.

Obligations

Fiscal Year 2005—$3,267,069

Transfusion Biology and Medicine

The purpose of this SCCOR is to foster multidisciplinary research on clinically relevant questions to enable rapid application of basic science findings to clinical problems associated with improving the availability, efficacy, safety, and quality of blood and blood products for therapeutic uses.

Obligations

Fiscal Year 2005—$4,400,002

Translational Human Stem Cell Research

The purpose of this SCCOR is to stimulate multi-disciplinary collaboration among basic stem cell biologists, researchers, and clinicians with disease-specific expertise, physicians and surgeons skilled in innovative modes of cell delivery, and investigators experienced in developing and assessing animal models of human diseases to conduct hitherto-unexplored projects such as preclinical studies for cell-based therapy employing human stem cells in animal models. Research findings will ultimately lead to innovative approaches for the prevention, treatment, and cure of disease, and will accelerate the translation of basic scientific discoveries into new therapies.

Obligations

Fiscal Year 2005—$1,509,262

National Center on Sleep Disorders Research

Neurobiology of Sleep and Sleep Apnea

The objective of this SCOR is to integrate molecular, cellular, and genetic approaches to sleep control with clinical investigations on the etiology and pathogenesis of sleep disorders, particularly sleep apnea.

Obligations

Fiscal Year 2005—$6,208,020

Comprehensive Sickle Cell Centers (U54) Program

The Comprehensive Sickle Cell Centers (CSCC) were instituted in FY 1972 to bridge the gap between research and service by combining basic and clinical research, clinical trials and applications training, and community service projects into one program. The patients recruited for the clinical studies are primarily from minority populations.

Obligations

Fiscal Year 2005—$24,313,796

Specialized Centers for Cell-Based Therapies for Heart, Lung, and Blood Diseases (U54) Program

The Specialized Centers for Cell-Based Therapies Program, which includes a Data and Coordinating Center, was initiated in FY 2005 to support preclinical and clinical studies for cell-based therapy for heart, lung, and blood diseases and sleep disorders. A key feature of the program is the ability to conduct preclinical studies in the first year or two of the program, in order to meet the requirements for an Investigational New Drug application prior to initiating clinical studies. Clinical studies are expected to be initiated by the beginning of the third year.

Obligations

Fiscal Year 2005—$6,957,161

Centers for AIDS Research (P30) Program

The NHLBI, along with five other NIH Institutes, contributes to the support of six Centers for AIDS Research that were established to provide a multidisciplinary environment that promotes basic, clinical, behavioral, and translational research activities in the prevention, detection, and treatment of HIV infection and AIDS. Almost half of the patient population comes from minority groups.

Obligations

Fiscal Year 2005—$2,829,119

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