9. Research Grants

• NHLBI Research Grants by Funding Mechanism: Fiscal Year 2009
• NHLBI Research Project Grant, Research Centers Grant, and Other Research Grant Obligations: Fiscal Years 1999–2009
• NHLBI Competing Research Project Grant Applications: Fiscal Years 1999–2009
• NHLBI Investigator-Initiated and Institute-Initiated Grant Obligations: Fiscal Years 1999–2009
• NHLBI Research Project Grants: Amount Funded by Type of Award, Fiscal Years 1999–2009
• NHLBI Research Project Grants: Average Costs, Fiscal Years 1999–2009
• NHLBI Cooperative Agreements (U01 and U10) Programs

NHLBI Research Grants by Funding Mechanism:  Fiscal Year 2009

NHLBI Total Research Grants by Category

Text-only with data points

NHLBI Research Project Grant,* Research Centers Grant, and Other Research Grant Obligations:  Fiscal Years 1999–2009

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

^* Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; and DP1 and R00 beginning in 2008.
^** Includes Research Career Programs; excludes General Research Support Grants.

NHLBI Research Project Grants,* Research Centers Grants, and Other Research Grant Obligations:  Fiscal Years 1999–2009

Dollars (Thousands)

^*Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; and DP1 and R00 beginning in 2008.
^** Includes Research Career Programs; excludes General Research Support Grants.

NHLBI Competing Research Project Grant Applications:* Fiscal Years 1999–2009

Number Reviewed and Awarded

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

Number Reviewed and Awarded and Percent Funded

^*  Includes R01, U01, P01, R03, R15, R21, R29, and R37; R33 beginning in 2001; DP2 and U19 beginning in 2007; and DP1 and R00 beginning in 2008.

Percent of Reviewed Applications Funded (Success Rate)

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

NHLBI Investigator-Initiated and Institute-Initiated Grant Obligations:  Fiscal Years 1999–2009

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

^* Includes RPGs, SBIRs/STTRs, Research Career Programs, and Other Research.
^** Includes RPGs, Centers Grants, Research Career Programs, Other Research, and Cooperative Agreement RFAs.

NHLBI Investigator-Initiated and Institute-Initiated Grant Obligations:  Fiscal Years 1999–2009

Dollars (Millions)

^* Includes RPGs, SBIRs/STTRs, Research Career Programs, and Other Research.
^** Includes RPGs, Centers Grants, Research Career Programs, Other Research, and Cooperative Agreement RFAs.

NHLBI Research Project Grants:*  Amount Funded by Type of Award, Fiscal Years 1999–2009

Dollars (Millions)

^* Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; and DP1 and R00 beginning in 2008.

Facility and Administrative (F&A) Costs of NHLBI Research Project Grants:* Fiscal Years 1999–2009

Dollars (Thousands)

^* Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; and DP1 and R00 beginning in 2008.
^** Excludes Program Evaluation Assessment of $1,216,000.

NHLBI Research Project Grants:*  Average Costs, Fiscal Years 1999–2009

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

^* Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; and DP1 and R00 beginning in 2008.

NHLBI Research Project Grants:*  Average Costs, Fiscal Years 1999–2009

Dollars (Thousands)

^* Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; and DP1 and R00 beginning in 2008.

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, at comparable levels of in-treatment LDL cholesterol, for preventing or delaying a major CVD event over a 4-year median followup period in patients with atherogenic dyslipidemia. Niacin is used to raise HDL ("good") cholesterol and simvastatin is used to lower LDL ("bad") cholesterol.

Obligations

Funding History:
Fiscal Year 2009—$1,132,517
Fiscal Years 2005–2008— $14,385,611
Total Funding to Date—$15,518,128

Current Active Organizations and Grant Numbers

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

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 patients with type 2 diabetes and angiographically proven coronary artery disease, stable angina, or ischemia. Revascularization combined with aggressive medical anti-ischemia treatment is being compared to aggressive medical anti-ischemia treatment alone. Simultaneously, researchers seek to determine whether insulin-sensitizing drugs such as metformin and the glitazones for controlling blood sugar level offer any survival advantage over drugs that increase insulin level. One-third of the patients are from minority populations.

Research findings indicate that neither prompt revascularization versus delayed revascularization or insulin sensitization versus insulin provision in patients with type 2 diabetes and stable CHD was superior in terms of mortality and the prevention of major cardiovascular events.

Obligations

Funding History:
Fiscal Year 2009—$1,129,551
Fiscal Years 2000–2008—$57,052,642
Total Funding to Date—$58,182,193

Current Active Organization and Grant Number

1. University of Pittsburgh
   Pittsburgh, Pennsylvania —HL-061744

Cardiovascular Cell Therapy Research Network, Initiated in Fiscal Year 2007

See Chapter 11. Clinical Trials.

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

The purpose of this project is to continue follow-up of the CHS cohort for cardiovascular events in order to enhance power among subgroups to study associations of CVD risk factors and incidence and prognosis following CVD events in older adults. The additional events will permit greater opportunity to address the study aims by CHS investigators and other researchers interested in making use of the study's extensive database and specimens. Seventeen percent of the participants are from minority populations.

Obligations

Funding History:
Fiscal Year 2009—$1,295,541
Fiscal Years 2005–2008—$4,561,785
Total Funding to Date—$5,857,326

Current Active Organization and Grant Number

1. University of Washington
   Seattle, Washington —HL-080295

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.

Obligations

Funding History:
Fiscal Year 2009—$0
Fiscal Years 2004–2008—$21,413,274
Total Funding to Date—$21,413,274

Current Active Organizations and Grant Numbers

1. University of Toledo Health
   Sciences Campus
   Toledo, Ohio —HL-071556
2. University of Minnesota, Twin Cities
   Minneapolis, Minnesota —HL-072734
3. University of Virginia
   Charlottesville, Virginia —HL-072735
4. Mid-America Heart Institute of
   St. Luke Hospital
   Kansas City, Missouri —HL-072736
5. Beth Israel Deaconess Medical Center
   Boston, Massachusetts —HL-072737

Catheter Ablation Versus Antiarrythmic Drug Therapy for Atrial Fibrillation (CABANA), Initiated in Fiscal Year 2009

The purpose of this trial is to determine whether percutaneous left atrial catheter ablation is superior to current pharmacologic therapy for eliminating atrial fibrillation.

Obligations

Funding History:
Fiscal Year 2009—$2,940,676
Total Funding to Date—$2,940,676

Current Active Organizations and Grant Numbers

1. Mayo Clinic, College of Medicine
   Rochester, Minnesota —HL-089645
2. Mayo Clinic, College of Medicine
   Rochester, Minnesota —HL-089709
3. Duke University
   Durham, North Carolina —HL-089786
4. Duke University
   Durham, North Carolina —HL-089907

Claudication: Exercise Versus Endoluminal 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 2009—$1,822,084
Fiscal Years 2005–2008—$4,745,409
Total Funding to Date—$6,567,493

Current Active Organizations and Grant Numbers

1. Rhode Island Hospital
   Providence, Rhode Island —HL-077221
2. Beth Israel Deaconess Medical Center
   Boston, Massachusetts —HL-081656

Clinical Research Consortium To Improve Resuscitation Outcomes, Initiated in Fiscal Year 2004

See Chapter 11. Clinical Trials.

Community-Responsive Intervention To Reduce Cardiovascular Risk in American Indians and Alaska Natives, Initiated in Fiscal Year 2006

See Chapter 11. Clinical Trials.

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 2009—$753,041
Fiscal Years 1997–2008—$6,928,502
Total Funding to Date—$7,681,543

Current Active Organization and Grant Number

1. University of Pittsburgh
   Pittsburgh, Pennsylvania —HL-033292

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 2009—$1,440,550
Fiscal Years 2000–2008—$15,925,349
Total Funding to Date—$17,365,899

Current Active Organizations and Grant Numbers

1. MedStar Research Institute
   Hyattsville, Maryland —HL-064244
2. Norton Sound Health Corporation
   Nome, Alaska —HL-082458
3. Southwest Foundation for
   Biomedical Research
   San Antonio, Texas —HL-082490

Heart Failure Clinical Research Network, Initiated in Fiscal Year 2006

See Chapter 11. Clinical Trials.

Improved Measures of Diet and Physical Activity for the Genes and Environment Initiative, Initiated in Fiscal Year 2007

The purpose of this program is to support the development of devices to improve diet and physical activity. The program is part of the Genes and Environment Initiative, a 4-year NIH-wide program designed to lay the foundation for understanding the complex interplay between genetic and environmental factors in human diseases.

Obligations

Funding History:
Fiscal Year 2009—$2,340,995
Fiscal Years 2007–2008—$4,851,197
Total Funding to Date—$7,192,192

Current Active Organizations and Grant Numbers

1. University of Pittsburgh
   Pittsburgh, Pennsylvania —HL-091736
2. Massachusetts Institute of Technology
   Cambridge, Massachusetts —HL-091737
3. Princeton Multimedia Technologies
   Corporation
   Princeton, New Jersey —HL-091738

Network for Cardiothoracic Surgical Investigation in Cardiovascular Medicine, Initiated in Fiscal Year 2007

See Chapter 11. Clinical Trials.

NHLBI Cardiac Development Consortium, Initiated in Fiscal Year 2009

The purpose of this study is to gain complete understanding of the regulatory networks controlling cardiovascular development. A consortium of multidisciplinary research teams will select key regulatory pathways, identify components of the pathways and targets, and rapidly disseminate data to the scientific community. Research results may lead to the development of regenerative therapies and tissue engineering approaches.

Obligations

Funding History:
Fiscal Year 2009—$1,113,042
Total Funding to Date—$1,113,042

Current Active Organizations and Grant Numbers

1. University of Utah
   Salt Lake City, Utah —HL-098160
2. Harvard University Medical School
   Boston, Massachusetts —HL-098166
3. J. David Gladstone Institutes
   San Francisco, California —HL-098179
4. University of Pittsburgh
   Pittsburgh, Pennsylvania —HL-098180

NHLBI Pediatric Cardiac Genomics Consortium, Initiated in Fiscal Year 2009

The purpose of this study is to conduct clinical and translational research on the genetic causes of congenital heart disease and genetic contributions to outcome in individuals with congenital heart disease.

Obligations

Funding History:
Fiscal Year 2009—$1,370,839
Total Funding to Date—$1,370,839

Current Active Organizations and Grant Numbers

1. Mount Sinai School of Medicine
   New York, New York —HL-098123
2. Children's Hospital Boston
   Boston, Massachusetts —HL-098147
3. Children's Hospital of Philadelphia
   Philadelphia, Pennsylvania —HL-098153
4. Yale University
   New Haven, Connecticut —HL-098162
5. Columbia University Health Sciences
   New York, New York —HL-098163

NHLBI Progenitor Cell Biology Consortium, Initiated in Fiscal Year 2009

The purpose of this study is to establish virtual research hubs that focus on progenitor cell biology. Investigators will seek to identify and characterize progenitor cell lineages, direct the differentiation of stem and progenitor cells to desired cell fates, and develop new strategies to address the unique challenges presented by the transplantation of these cells.

Obligations

Funding History:
Fiscal Year 2009—$22,721,547
Total Funding to Date—$22,721,547

Current Active Organizations and Grant Numbers

1. Children's Hospital of Philadelphia
   Philadelphia, Pennsylvania —HL-099656
2. University of Wisconsin, Madison
   Madison, Wisconsin —HL-099773
3. Johns Hopkins University
   Baltimore, Maryland —HL-099775
4. Stanford University
   Stanford, California —HL-099776
5. Fred Hutchinson Cancer Research Center
   Seattle, Washington —HL-099993
6. Stanford University
   Stanford, California —HL-099995
7. Stanford University
   Stanford, California —HL-099999
8. Children's Hospital Boston
   Boston, Massachusetts —HL-100001
9. Fred Hutchinson Cancer Research Center
   Seattle, Washington —HL-100395
10. Stanford University
    Stanford, California —HL-100397
11. Vanderbilt University
    Nashville, Tennessee —HL-100398
12. University of Texas Southwestern
    Medical Center
    Dallas, Texas —HL-100401
13. Massachusetts General Hospital
    Boston, Massachusetts —HL-100402
14. University of Pennsylvania
    Philadelphia, Pennsylvania —HL-100405
15. J. David Gladstone Institutes
    San Francisco, California —HL-100406
16. University of Minnesota, Twin Cities
    Minneapolis, Minnesota —HL-100407
17. Massachusetts General Hospital
    Boston, Massachusetts —HL-100408

Occluded Artery Trial (OAT), Initiated in Fiscal Year 1999

The purpose of this study is to determine whether percutaneous revascularization to open an occluded artery within a few days or as long as a month following an acute MI in asymptomatic patients improves their outcome. Although the benefits of early restoration of blood flow following an acute MI have been well-established, it is not known whether later intervention is also beneficial. The trial is in a long-term followup phase.

Obligations

Funding History:
Fiscal Year 2009—$1,269,829
Fiscal Years 1999–2008—$19,953,495
Total Funding to Date—$21,223,324

Current Active Organizations and Grant Numbers

1. New York University
   School of Medicine
   New York, New York —HL-062509
2. Maryland Medical Research
   Institute, Inc.
   Baltimore, Maryland —HL-062511

Pediatric Heart Network, Initiated in Fiscal Year 2006

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 38 percent minority participation.

Obligations

Funding History:
Fiscal Year 2009—$4,959,258
Fiscal Years 2001–2008—$62,887,956
Total Funding to Date—$67,847,214

Current Active Organizations and Grant Numbers

1. Vanderbilt University
   Nashville, Tennessee —HL-065962
2. Children's Hospital and Research Center
   Oakland, California —HL-069757

Practice-Based Opportunity for Weight Reduction (POWER) Trials,^* Initiated in Fiscal Year 2006

See Chapter 11. Clinical Trials.

Programs of Excellence in Nanotechnology, Initiated in Fiscal Year 2005

The purpose of this program is to establish multidisciplinary teams to develop 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 2009—$11,279,810
Fiscal Years 2005–2008—$39,522,116
Total Funding to Date—$50,801,926

Current Active Organizations and Grant Numbers

1. Emory University
   Atlanta, Georgia —HL-080711
2. Burnham Institute for Medical Research
   La Jolla, California —HL-080718
3. Washington University
   St. Louis, Missouri —HL-080729
4. Massachusetts General Hospital
   Boston, Massachusetts —HL-080731

*Formerly known as Weight-Loss in Obese Adults with Cardiovascular Risk Factors.

Rule Out Myocardial Infarction Using Computed Assisted Tomography (ROMICAT II), Initiated in Fiscal Year 2009

The purpose of this study is to determine whether implementation of cardiac computed assisted tomography early in the emergency department triage process will enable immediate and safe discharge without further testing of a significant number of patients with acute chest pain.

Obligations

Funding History:
Fiscal Year 2009—$2,111,994
Total Funding to Date—$2,111,994

Current Active Organizations and Grant Numbers

1. Massachusetts General Hospital
   Boston, Massachusetts —HL-092022
2. Massachusetts General Hospital
   Boston, Massachusetts —HL-092040

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. Phase IV expanded the family study to 120 families comprising 3,600 members to investigate genetic and environmental contributors of CVD. Phase V will examine the family study cohort to assess genetic relationships to risk factor change over a 5‑year period.

Obligations

Funding History:
Fiscal Year 2009—$1,026,776
Fiscal Years 1988–2008—$69,831,832
Total Funding to Date—$70,858,608

Current Active Organization and Grant Number

1. Southwest Foundation for
   Biomedical Research
   San Antonio, Texas —HL-065520

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 2009—$726,648
Fiscal Years 2002–2008—$38,081,071
Total Funding to Date—$38,807,719

Current Active Organizations and Grant Numbers

1. Duke University
   Durham, North Carolina —HL-069013
2. Duke University
   Durham, North Carolina —HL-069015

Targeted Approaches to Weight Control for Young Adults, Initiated in Fiscal Year 2009

See Chapter 11. Clinical Trials

Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA) Trials, Initiated in Fiscal Year 2009

The purpose of this program is to determine whether therapeutic hypothermia after pediatric cardiac arrest improves outcomes, including survival, in infants and children.

Obligations

Funding History:
Fiscal Year 2009—$3,648,449
Total Funding to Date—$3,648,449

Current Active Organizations and Grant Numbers

1. University of Utah
   Salt Lake City, Utah —HL-094339
2. University of Michigan at Ann Arbor
   Ann Arbor, Michigan —HL-094345

Translating Basic Behavioral and Social Science Discoveries Into Interventions To Reduce Obesity, Initiated in Fiscal Year 2009

The purpose of this study is to develop innovative obesity-reducing strategies rather than evaluating the effectiveness of already well-defined or proven strategies. Some projects are expected to have 50- to 100-percent participation from minorities. The new strategies should be effective in small-scale trials, acceptable to target populations of interest, and ready to be tested in large-scale randomized clinical and community trials.

Obligations

Funding History:
Fiscal Year 2009—$5,431,213
Total Funding to Date—$5,431,213

Current Active Organizations and Grant Numbers

1. Claremont Graduate University
   Claremont, California —HL-097839
2. Weill Medical College of
   Cornell University
   New York, New York —HL-097843
3. Wayne State University
   Detroit, Michigan —HL-097889
4. Rush University Medical Center
   Chicago, Illinois —HL-097894
5. University of California, San Francisco
   San Francisco, California —HL-097973

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 2.5 years in approximately 1,700 overweight or obese adults. Of those, 1,032 who lost at least 9 pounds during a 6-month weight loss program were randomized into one of three maintenance groups: brief monthly personal counseling on diet and physical activities; Web-based intervention providing similar advice; or self-directed control, where participants received minimal further intervention. Approximately 40 percent of participants were black.

The majority of individuals who successfully completed an initial behavioral weight loss program maintained a weight below their initial level. Monthly brief personal contact provided modest benefits to sustaining weight loss, whereas an interactive technology-based intervention provided early but transient benefits.

Obligations

Funding History:
Fiscal Year 2009—$149,857
Fiscal Years 2003–2008—$17,463,982
Total Funding to Date—$17,613,839

Current Active Organization and Grant Number

1. Kaiser Foundation Research Institute
   Oakland, California —HL-068676

Lung Diseases Program

Asthma Networks (AsthmaNet)

See Chapter 11. Clinical Trials.

Childhood Asthma Management Program–Continuation Study (CAMP–CS)/Phase III, Initiated in Fiscal Year 2007

The objective of this observational study is to follow the original CAMP cohort for 4 more years (through ages 21–29) to determine clinical and genetic risk factors for patterns of lung function decline indicative of chronic air flow obstruction in later adulthood; 31 percent of the participants are from minority groups.

Obligations

Funding History:
Fiscal Year 2009—$1,145,547
Fiscal Years 2007–2008—$4,043,232
Total Funding to Date—$5,188,779

Current Active Organizations and Grant Numbers

1. Washington University
   St. Louis, Missouri —HL-075232
2. Hospital for Sick Children
   Toronto, Ontario —HL-075407
3. Johns Hopkins University
   Baltimore, Maryland —HL-075408
4. Asthma, Inc.
   Seattle, Washington —HL-075409
5. University of California, San Diego
   La Jolla, California —HL-075415
6. National Jewish Medical
   and Research Center
   Denver, Colorado —HL-075416
7. Johns Hopkins University
   Baltimore, Maryland —HL-075417
8. Brigham and Women's Hospital
   Boston, Massachusetts —HL-075419
9. University of New Mexico
   Albuquerque, New Mexico —HL-075420

COPD Clinical Research Network, Initiated in Fiscal Year 2003

See Chapter 11. Clinical Trials.

Genetic Epidemiology of COPD, Initiated in Fiscal Year 2007

The purpose of this study is to perform a genome-wide association analysis to identify the genetic risk factors that determine susceptibility for COPD and COPD-related phenotypes in a large biracial population.

Obligations

Funding History:
Fiscal Year 2009—$9,063,922
Fiscal Years 2007–2008—$14,234,023
Total Funding to Date—$23,297,945

Current Active Organizations and Grant Numbers

1. Brigham and Women's Hospital
   Boston, Massachusetts —HL-089856
2. National Jewish Medical and
   Research Center
   Denver, Colorado —HL-089897

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

See Chapter 11. Clinical Trials.

Infant Study of Inhaled Saline in Cystic Fibrosis (ISIS), Initiated in Fiscal Year 2008

The purpose of this randomized clinical trial is to assess the efficacy and safety of 7 percent hypertonic saline (HS) inhaled twice daily for 48 weeks among infants with CF aged 4 to 15 months at enrollment. Investigators are seeking to determine whether hypertonic saline will improve hyperinflation and obstructive lung disease as measured by infant lung function testing compared with the control agent (isotonic saline).

Obligations

Funding History:
Fiscal Year 2009—$736,708
Fiscal Year 2008—$732,476
Total Funding to Date—$1,469,184

Current Active Organizations and Grant Numbers

1. Children's Hospital and Regional
   Medical Center
   Seattle, Washington —HL-092931
2. University of Washington
   Seattle, Washington —HL-092932

Microbiome of the Lung and Respiratory Tract in HIV-Infected Individuals and HIV-Uninfected Controls, Initiated in Fiscal Year 2009

The purpose of this study is to characterize the microbiome of the lung alone or in combination with the upper airways in HIV-infected individuals and matched HIV-uninfected controls. Investigators will use molecular techniques to identify bacteria, and if possible, other organisms (e.g., viruses, cell-wall deficient organisms, protozoa, and fungi). Data will be used to examine the effects of changes in the respiratory microbiome on the pathogenesis and progression of HIV disease, HIV-related respiratory complications, and anti-HIV therapies.

Obligations

Funding History:
Fiscal Year 2009—$5,390,250
Total Funding to Date—$5,390,250

Current Active Organizations and Grant Numbers

1. University of Pennsylvania
   Philadelphia, Pennsylvania —HL-098957
2. George Washington University
   Washington, DC —HL-098958
3. Indiana University-Purdue University
   at Indianapolis
   Indianapolis, Indiana —HL-098960
4. University of Michigan at Ann Arbor
   Ann Arbor, Michigan —HL-098961
5. University of Pittsburgh
   Pittsburgh, Pennsylvania —HL-098962
6. University of California, San Francisco
   San Francisco, California —HL-098964
7. University of Colorado
   Denver, Colorado —HL-098966

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 2009—$3,192,109
Fiscal Years 2000–2008— $23,813,429
Total Funding to Date—$27,005,538

Current Active Organization and Grant Number

1. Brigham and Women's Hospital
   Boston, Massachusetts —HL-065899

Randomized Controlled Study of Adenotonsillectomy for Childhood Sleep Apnea, Initiated in Fiscal Year 2006

The purpose of this randomized controlled study is to compare adenotonsillectomy and watchful waiting followed by reevaluation after 7 months for treatment of OSA in children aged 5 to 9 years; 50 percent of the participants are expected to be black.

Obligations

Funding History:
Fiscal Year 2009—$2,500,880
Fiscal Years 2006–2008—$6,000,740
Total Funding to Date—$8,501,620

Current Active Organizations and Grant Numbers

1. Case Western Reserve University
   Cleveland, Ohio —HL-083075
2. University of Pennsylvania
   Philadelphia, Pennsylvania —HL-083129

Randomized Trial of Maternal Vitamin D Supplementation To Prevent Childhood Asthma, Initiated in Fiscal Year 2009

The purpose of this randomized clinical trial is to determine whether higher vitamin D intake and increased levels in a pregnant woman will prevent asthma and allergy in her child at age 3. Investigators will recruit 870 pregnant women who are in the first trimester of pregnancy. This sample will be randomized to one of two treatment arms of a 4-year clinical trial: 4,000 international units of vitamin D in addition to typical prenatal vitamins and typical prenatal vitamins alone.

Obligations

Funding History:
Fiscal Year 2009—$2,510,267
Total Funding to Date—$2,510,267

Current Active Organizations and Grant Numbers

1. Washington University
   St. Louis, Missouri —HL-091075
2. Brigham and Women's Hospital
   Boston, Massachusetts —HL-091528

Sedation Management in Pediatric Patients With Acute Respiratory Failure, Initiated in Fiscal Year 2008

The purpose of this randomized clinical trial is to test an innovative approach to sedation management that includes team education and consensus on the use of sedatives in pediatric patients supported on mechanical ventilation; team identification of each patient's trajectory of illness and daily prescription of a sedation goal; use of a nurse-implemented goal-directed comfort algorithm that guides moment-to-moment titration of opioids and benzodiazepines; and team feedback on sedation management performance. Investigators will randomize 2,754 critically ill infants and children into two study groups: sedation management intervention and usual care.

Obligations

Funding History:
Fiscal Year 2009—$3,884,512
Fiscal Year 2008—$567,715
Total Funding to Date—$4,452,227

Current Active Organizations and Grant Numbers

1. University of Pennsylvania
   Philadelphia, Pennsylvania —HL-086622
2. Children's Hospital Boston
   Boston, Massachusetts —HL-086649

Study of Acid Reflux Therapy for Children With Asthma, Initiated in Fiscal Year 2006

The purpose of this randomized controlled clinical trial is to investigate whether an approved proton-pump inhibitor lansoprazole will reduce asthma exacerbations in children (aged 6–16 years) with poorly controlled asthma. Thirty percent of participants will be from minority populations.

Obligations

Funding History:
Fiscal Year 2009—$882,798
Fiscal Years 2006–2008—$2,462,212
Total Funding to Date—$3,345,010

Current Active Organizations and Grant Numbers

1. Emory University
   Atlanta, Georgia —HL-080433
2. Johns Hopkins University
   Baltimore, Maryland —HL-080450

Study of Asthma and Nasal Steroids (STAN), Initiated in Fiscal Year 2009

The purpose of this clinical trial is to determine whether the addition of treatment of chronic rhinitis and sinusitis with a nasal steroid will improve asthma control. Investigators will randomize 380 patients with poorly controlled asthma and chronic rhinitis/sinusitis to a nasal steroid or matching placebo in addition to their regular asthma treatment. One third of participants are expected to be from minority populations.

Obligations

Funding History:
Fiscal Year 2009—$724,724
Total Funding to Date—$724,724

Current Active Organizations and Grant Numbers

1. University of Vermont
   Burlington, Vermont —HL-089464
2. Johns Hopkins University
   Baltimore, Maryland —HL-089510

Study of Soy Isoflavones in Asthma (SOYA), Initiated in Fiscal Year 2009

The purpose of this double-blind, randomized controlled trial is to assess the effectiveness of genistein supplements (soy isoflavone) in improving lung function in patients with poorly controlled asthma. The study will include 380 patients with low dietary soy intake, ages 12 years and older, who are taking inhaled corticosteroids, leukotriene modifiers, or both and have poorly controlled asthma. Participants will be randomly assigned to treatment with either a soy isoflavone supplement (containing genistein, daidzein, and glycitein) 100 mg daily or to placebo for 6 months. Thirty percent of participants are expected to be from minority populations.

Obligations

Funding History:
Fiscal Year 2009—$774,607
Total Funding to Date—$774,607

Current Active Organizations and Grant Numbers

1. Northwestern University
   Evanston, Illinois —HL-087987
2. Johns Hopkins University
   Baltimore, Maryland —HL-088367

Trial of Late Surfactant To Prevent Bronchopulmonary Dysplasia (TOLSURF), Initiated in Fiscal Year 2009

The purpose of this randomized controlled clinical trial is to determine whether late doses of surfactant, in addition to iNO, administered to extremely low gestational age neonates (< 30 weeks) who require mechanical ventilation between 7 and 14 days of age, will increase survival without bronchopulmonary dysplasia.

Obligations

Funding History:
Fiscal Year 2009—$1,986,898
Total Funding to Date—$1,986,898

Current Active Organizations and Grant Numbers

1. University of California, San Francisco
   San Francisco, California —HL-094338
2. University of California, San Francisco
   San Francisco, California —HL-094355

Blood Diseases and Resources

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

See Chapter 11. Clinical Trials.

Bridging Anticoagulation on Patients Requiring Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial, Initiated in Fiscal Year 2008

The purpose of this study is to determine the safety and efficacy of low molecular weight heparin (LMWH) in adults with atrial fibrillation who stop warfarin in preparation for surgery. The trial will randomly allocate 3,282 patients with atrial fibrillation to either LMWH or matching placebo before and after surgery. Investigators hypothesize that simply withholding warfarin in a perioperative setting for patients with atrial fibrillation will not meaningfully increase the risk for arterial thromboembolism and will forestall hemorrhagic complications, compared with a strategy using LMWH before and after surgery. One third of participants are expected to be from minority populations.

Obligations

Funding History:
Fiscal Year 2009—$5,673,071
Fiscal Year 2008—$4,632,060
Total Funding to Date—$10,305,131

Current Active Organizations and Grant Numbers

1. Duke University
   Durham, North Carolina —HL-86755
2. Duke University
   Durham, North Carolina —HL-87229

Pharmacomechanical Catheter-Directed Thrombolysis for Acute DVT–ATTRACT Trial, Initiated in Fiscal Year 2008

The purpose of this study is to determine whether adjunctive pharmacomechanical catheter-directed thrombolysis, which includes intrathrombus administration of recombinant tissue plasminogen activator, can prevent postthrombotic syndrome in patients with symptomatic proximal deep vein thrombosis (DVT) compared with optimal standard DVT therapy alone.

Obligations

Funding History:
Fiscal Year 2009—$2,107,633
Fiscal Year 2008—$2,070,898
Total Funding to Date—$4,178,531

Current Active Organizations and Grant Numbers

1. McMaster University
   Hamilton, Ontario —HL-088118
2. Washington University
   St. Louis, Missouri —HL-088476

Stroke With Transfusions Changing to Hydroxyurea (SWITCH), 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. Participants will be black.

Obligations

Funding History:
Fiscal Year 2009—$3,215,757
Fiscal Years 2005–2008—$14,636,993
Total Funding to Date—$17,852,750

Current Active Organizations and Grant Numbers

1. St. Jude Children's Research Hospital
   Memphis, Tennessee —HL-078787
2. Rho Federal Systems Division, Inc.
   Chapel Hill, North Carolina —HL-078987

Thalassemia (Cooley's Anemia) Clinical Research Network, Initiated in Fiscal Year 2000

See Chapter 11. Clinical Trials.

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

See Chapter 11. Clinical Trials.

NHLBI Research Centers (P50) Programs

Specialized Centers of Clinically Oriented Research (P50)

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 emphasized 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 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. The SCOR program ended in 2008.

The funding history for individual SCCORs supported by the Institute is listed below.

Obligations (Dollars in Thousands)

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 2009—$13,486,219

Current Active Organizations and Grant Numbers

1. Columbia University
   Health Science Center
   New York, New York —HL-077096
2. University of Alabama at Birmingham
   Birmingham, Alabama —HL-077100
3. University of Cincinnati
   Cincinnati, Ohio —HL-077101
4. Cleveland Clinical Lerner College
   Cleveland, Ohio —HL-077107
5. Washington University
   St. Louis, Missouri —HL-077113

Vascular Injury, Repair, and Remodeling

The purpose of this SCCOR is to foster multidisciplinary research on clinically relevant questions that will enable basic science findings to be more rapidly translated into clinical applications. Major goals of the program are to stimulate interdependent clinical and multidisciplinary basic research projects that investigate molecular and cellular mechanisms of vascular injury, repair, and remodeling; promote patient-oriented research that will improve our ability to prevent, detect, characterize, manage, and treat vascular diseases; and develop the skills and research capabilities of new clinical investigators.

Obligations

Fiscal Year 2009—$12,496,418

Current Active Organizations and Grant Numbers

1. Washington University
   St. Louis, Missouri —HL-083762
2. University of Texas Health
   Science Center
   Houston, Texas —HL-083794
3. University of Pennsylvania
   Philadelphia, Pennsylvania —HL-083799
4. Stanford University
   Stanford, California —HL-083800
5. Boston University Medical Campus
   Boston, Massachusetts —HL-083801
6. Beth Israel Deaconess Medical Center
   Boston, Massachusetts —HL-083813

Lung Diseases Program

Chronic Obstructive Pulmonary Disease

The purpose of this SCCOR is to foster multidisciplinary research to accelerate progress in the diagnosis, prevention, and treatment of COPD. The program will include a broad spectrum of basic and clinical research that will encompass animal models of COPD pathogenesis, human proteomic, genetic and genomic investigations, technologically refined disease phenotypes classification, and the development of new experimental therapeutic interventions.

Obligations

Fiscal Year 2009—$11,227,890

Current Active Organizations and Grant Numbers

1. Washington University
   St. Louis, Missouri —HL-084922
2. Weill Medical College
   of Cornell University
   New York, New York —HL-084936
3. Johns Hopkins University
   Baltimore, Maryland —HL-084945
4. University of Pittsburgh
   Pittsburgh, Pennsylvania —HL-084948

Host Factors in Chronic Lung Diseases

The purpose of this SCCOR is to identify alterations in host responses and lung homeostasis and to determine how the dysregulation contributes to development or progression of chronic lung diseases. Enhanced understanding of these processes should facilitate identification of new targets for intervention, providing the basis for development of new therapeutic options for prevention and treatment of chronic lung diseases.

Obligations

Fiscal Year 2009—$8,472,710

Current Active Organizations and Grant Numbers

1. Duke University
   Durham, North Carolina —HL-084917
2. Children's Hospital
   Pittsburgh, Pennsylvania —HL-084932
3. University of North Carolina
   Chapel Hill, North Carolina —HL-084934

Pulmonary Vascular Disease

The objective of this SCCOR is to facilitate multidisciplinary research that proposes original hypotheses and applies cutting-edge approaches, including genomics and proteomics, to clinical issues in pulmonary vascular disease.

Obligations

Fiscal Year 2009—$6,480,043

Current Active Organizations and Grant Numbers

1. University of Colorado at Denver
   Denver, Colorado —HL-084923
2. Johns Hopkins University
   Baltimore, Maryland —HL-084946

Blood Diseases and Resources Program

Hemostatic and Thrombotic Diseases

The purpose of this SCCOR is to conduct multidisciplinary research to improve the prevention, diagnosis, and treatment of thrombotic and bleeding disorders. The program will support rapid translation of basic science findings into clinical application.

Obligations

Fiscal Year 2009—$8,412,822

Current Active Organizations and Grant Numbers

1. Vanderbilt University
   Nashville, Tennessee —HL-081009
2. Cleveland Clinic Lerner College
   Cleveland, Ohio —HL-081011
3. University of Pennsylvania
   Philadelphia, Pennsylvania —HL-081012

Transfusion Biology and Medicine

The purpose of this SCCOR 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 2009—$4,650,915

Current Active Organizations and Grant Numbers

1. Puget Sound Blood Center
   Seattle, Washington —HL-081015
2. University of California, San Francisco
   San Francisco, California —HL-081027

Basic and Translational Research Program (U54)

The NHLBI reconfigured the Comprehensive Sickle Cell Centers program into a Basic and Translational Research Program (BTRP). The Program emphasizes fundamental investigations and their translation into initial studies in humans, as well as community translation to promote evidence-based clinical practice. The BTRP continues to support the Sickle Cell Disease Scholars program for the career development of young investigators and the Summer-for-Sickle Cell-Science program for research training and mentoring of high-school students. These components are part of a larger effort by NHLBI to prepare the next generation of scientists to advance the field of SCD research.

Obligation

Fiscal Year 2009—$13,566,634

Current Active Organizations and Grant Numbers

1. Thomas Jefferson University
   Philadelphia, Pennsylvania —HL-070585
2. RHO Federal Systems Division, Inc.
   Chapel Hill, North Carolina —HL-070587
3. University of Texas
   Southwestern Medical Center
   Dallas, Texas —HL-070588
4. St. Jude Children's Research Hospital
   Memphis, Tennessee —HL-070590
5. Boston Medical Center
   Boston, Massachusetts —HL-070819
6. Children's Hospital Medical Center
   Cincinnati, Ohio —HL-070871
7. Medical College of Wisconsin
   Milwaukee, Wisconsin —HL-090503
8. Howard University
   Washington, DC —HL-090508
9. Children's Hospital
   Los Angeles, California —HL-090511
10. University of Chicago
    Chicago, Illinois —HL-090513
11. Johns Hopkins University
    Baltimore, Maryland —HL-090515
12. Virginia Commonwealth University
    Richmond, Virginia —HL-090516
13. University of Miami School of Medicine
    Miami, Florida —HL-090569

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 2009—$7,649,361

Current Active Organizations and Grant Numbers

1. Baylor College of Medicine
   Houston, Texas —HL-081007
2. EMMES Corporation
   Rockville, Maryland —HL-081021
3. Cedars-Sinai Medical Center
   Los Angeles, California —HL-081028
4. Massachusetts General Hospital
   Boston, Massachusetts —HL-081030

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 2009—$3,254,346

Current Active Organizations and Grant Numbers

1. New York University
   School of Medicine
   New York, New York —AI-027742
2. University of Washington
   Seattle, Washington —AI-027757
3. University of California, San Francisco
   San Francisco, California —AI-027763
4. University of Alabama at Birmingham
   Birmingham, Alabama —AI-027767
5. University of California, Los Angeles
   Los Angeles, California —AI-028697
6. Baylor University
   Houston, Texas —AI-036211
7. University of California, San Diego
   La Jolla, California —AI-036214
8. Case Western Reserve University
   Cleveland, Ohio —AI-036219
9. University of Massachusetts
   Medical School
   Worcester, Massachusetts —AI-042845
10. Miriam Hospital
    Providence, Rhode Island —AI-042853
11. University of Pennsylvania
    Philadelphia, Pennsylvania —AI-045008
12. Emory University
    Atlanta, Georgia —AI-050409
13. University of North Carolina
    at Chapel Hill
    Chapel Hill, North Carolina —AI-050410
14. Yeshiva University
    New York, New York —AI-051519
15. Vanderbilt University
    Nashville, Tennessee —AI-054999
16. Harvard Medical School
    Boston, Massachusetts —AI-060354
17. Duke University
    Durham, North Carolina —AI-064518
18. University of Miami
    School of Medicine
    Coral Gables, Florida —AI-073961
19. University of Rochester
    Rochester, New York —AI-078498
20. Rush University Medical Center
    Chicago, Illinois —AI-082151

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