« Factbook Table of Contents

11. Clinical Trials

• NHLBI Investigator-Initiated Clinical Trials: Fiscal Years 1996–2006
• NHLBI Investigator-Initiated Phase III Clinical Trials, Fiscal Year 2006: Summary by Program
• Institute-Initiated Clinical Trials: Fiscal Years 1996–2006
• Institute-Initiated Clinical Trials, Fiscal Year 2006: Summary by Program
• Heart and Vascular Diseases Program
• Lung Diseases Program
• Blood Diseases and Resources Program

A clinical trial is defined as a scientific research study undertaken with human subjects to evaluate prospectively the diagnostic, prophylactic, or therapeutic effect of a drug, device, regimen, or procedure used or intended ultimately for use in the practice of medicine or the prevention of disease. A clinical trial is planned and conducted prospectively and includes a concurrent control group or other appropriate comparison group.

NHLBI Investigator-Initiated Clinical Trials: Fiscal Years 1996–2006

* Paid by U01/U10
^† Previously an Institute-Initiated Clinical Trial.NHLBI Investigator-Initiated Clinical Trials.

Back to Top

NHLBI Investigator-Initiated Phase III Clinical Trials, Fiscal Year 2006: Summary by Program

* Paid by U01/U10.
^† Previously an Institute-Initiated Clinical Trial.

Back to Top

Institute-Initiated Clinical Trials: Fiscal Years 1996–2006

Contracts

* Investigator-Initiated From 1998 to 2002.

Back to Top

Institute-Initiated Clinical Trials, Fiscal Year 2006: Summary by Program

Contracts

Cooperative Agreements

Back to Top

Heart and Vascular Diseases Program

Action To Control Cardiovascular Risk in Diabetes (ACCORD), Initiated in Fiscal Year 1999

The purpose of this study is to evaluate three diabetic treatment strategies (intensive glycemic control, blood pressure control, and fibrate treatment to raise HDL-cholesterol and lower triglycerides) to prevent major cardiovascular events in patients with type 2 diabetes mellitus. The primary outcome measure is CVD mortality or major morbidity (MI and stroke). A vanguard phase of about 1,000 participants was completed in FY 2002, and the main trial proceeded in FY 2003.

Obligations

Funding History:
   Fiscal Year 2006—$0
   Fiscal Years 1999–2005—$90,895,802
Total Funding to Date—$90,895,802

Back to Top

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

The purpose of this study is to establish a resuscitation research consortium to conduct research in cardiopul-monary arrest and traumatic injury leading to arrest. The consortium will facilitate the rapid translation of promising scientific and clinical advances to improve resuscitation outcomes.

Obligations

Funding History:
   Fiscal Year 2006—$9,728,012
   Fiscal Year 2004–2005—$16,224,715
Total Funding to Date—$25,952,727

Back to Top

Clinical Trials in Organ Transplantation (CTOT), Initiated in Fiscal Year 2005

The purpose of this program is to support a multisite consortium for interventional or observational clinical studies to enhance our understanding of, and ultimately reduce, the immune-mediated morbidity and mortality of organ transplantation.

Obligations

Funding History:
   Fiscal Year 2006—$1,855,350
   Fiscal Year 2005—$1,900,000
Total Funding to Date—$3,755,350

Dynamic Assessment of Patient-Reported Chronic Disease Outcomes, Initiated in Fiscal Year 2004

The purpose of this study, which emanates from a NIH Roadmap Initiative, is to develop a computerized system of patient-reported outcomes that will meet the needs of clinical researchers across a wide variety of chronic disorders and diseases. Investigators will develop and test a large bank of items measuring patient-reported outcomes; create a computerized adaptive testing system that will allow for efficient assessment of patient-reported outcomes in clinical research; and create a publicly available system that can be added to and modified periodically for clinical researchers.

Obligations

Funding History:
   Fiscal Year 2006—$0
   Fiscal Year 2004–2005—$1,009,694
Total Funding to Date—$1,009,694

Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), Initiated in Fiscal Year 1999

The purpose of this study is to compare the efficacy of pulmonary artery catheterization-directed (PAC) treatment strategy to a noninvasive treatment strategy on morbidity and mortality in patients with severe congestive heart failure. Forty-two percent of the participants are black. Results of the trial presented in November 2004 showed that PAC did not increase or decrease death or the number of days hospitalized in patients with severe heart failure. Follow-up studies are comparing the quality of life, ability to exercise, and changes in the heart’s structure and function as measured by echocardiograms between the groups.

Obligations

Funding History:
   Fiscal Year 2006—$311,000
   Fiscal Year 1999–2005—$4,699,537
Total Funding to Date—$5,010,537

Back to Top

Heart Failure Clinical Research Network, Initiated in Fiscal Year 2006

The purpose of this network is to accelerate research in the diagnosis and management of heart failure in order to improve outcomes through optimal application of existing therapies and evaluation of novel therapies. The network will provide the necessary infrastructure to develop, coordinate, and conduct multiple collaborative clinical protocols to facilitate application of emerging basic science discoveries into clinical investigations.

Obligations

Funding History:
   Fiscal Year 2006—$5,642,461
Total Funding to Date—$5,642,461

NICHD Cooperative Multicenter Neonatal Research Network, Initiated in Fiscal Year 2006

The purpose of this network is to investigate the safety and efficacy of treatment and management strategies to care for newborn infants, particularly those related to management of low birth weight infants. The objective of this program is to facilitate evaluation of the strategies by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly than individual centers acting alone.

Obligations

Funding History:
   Fiscal Year 2006—$1,336,159
Total Funding to Date—$1,336,159

Pediatric Heart Network, Initiated in Fiscal Year 2006

The objective of this study is to establish a clinical network to evaluate novel treatment methods and management strategies for children with structural congenital heart disease, inflammatory heart disease, heart muscle disease, or arrhythmias.

Obligations

Funding History:
   Fiscal Year 2006—$6,988,223
Total Funding to Date—$6,988,223

Back to Top

Pediatric HIV/AID Cohort Study (PHACS)—Data and Operations Center, Initiated in Fiscal Year 2006

The purpose of this study is to create a body of data to understand more fully the effect of HIV on sexual maturation, pubertal development, and socialization of perinatally HIV-infected preadolescents and adolescents, and to acquire more definitive information regarding long-term safety of antiretroviral agents when used during preg-nancy and in newborns.

Obligations

Funding History:
   Fiscal Year 2006—$1,000,000
Total Funding to Date—$1,000,000

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

The purpose of this community-based study is to test the effects of a school–community-linked intervention to prevent decline in physical activity and cardiorespiratory fitness seen during adolescence in girls. The study is being conducted in 36 schools; 43 percent of the population are minorities.

Obligations

Funding History:
   Fiscal Year 2006—$905,336
   Fiscal Years 2000–2005—$33,305,766
Total Funding to Date—$34,211,102

Trial of Aldosterone Antagonists in Adults With Preserved Ejection Fraction Congestive Heart Failure, (TOPCAT) Initiated in Fiscal Year 2004

The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy to reduce mortality in patients who have heart failure with preserved systolic function.

Obligations

Funding History:
   Fiscal Year 2006—$5,479,690
   Fiscal Year 2004–2005—$5,998,973
Total Funding to Date—$11,478,663

Back to Top

Weight Loss in Obese Adults With Cardiovascular Risk Factors, Initiated in Fiscal Year 2006

The purpose of this study is to conduct randomized clinical trials in routine clinical practice settings to test the effectiveness of weight loss interventions in obese patients who have one or more additional cardiovascular risk factors. An important secondary focus of these effectiveness clinical trials is to incorporate the weight loss strategies with approaches to improve application of evidence-based guidelines to reduce the other cardiovascular risk factors commonly present in obese patients, such as elevated lipids, hypertension, metabolic syndrome, diabetes, or cigarette smoking.

Obligations

Funding History:
   Fiscal Year 2006—$2,567,146
Total Funding to Date—$2,567,146

Lung Diseases Program

Acute Respiratory Distress Syndrome Clinical Network (ARDSNet), Initiated in Fiscal Year 1994

The purpose of this network is to develop and conduct randomized controlled clinical trials to prevent, treat, and improve the outcome of patients with acute lung injury, ARDS, and other related critical illnesses.

Obligations

Funding History:
   Fiscal Year 2006—$7,396,064
   Fiscal Years 1994–2005—$50,915,641
Total Funding to Date—$58,311,705

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

The purpose of this network is to evaluate current and novel therapies and management strategies for adult asthma and to ensure that findings are rapidly disseminated to the medical community. Approximately 33 percent of the participants will be minorities.

Obligations

Funding History:
   Fiscal Year 2006—$7,838,310
   Fiscal Years 2003–2005—$25,272,584
Total Funding to Date—$33,110,894

Back to Top

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

The purpose of this clinical network is to evaluate current and novel therapies and management strategies for children with asthma. Emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.

Obligations

Funding History:
   Fiscal Year 2006—$5,734,754
   Fiscal Years 1999–2005—$37,102,539
Total Funding to Date—$42,837,293

COPD Clinical Research Network, Initiated in Fiscal Year 2003

The purpose of this network is to investigate disease management approaches in patients with moderate-to-severe COPD and to ensure that the findings are rapidly disseminated to the medical community.

Obligations

Funding History:
   Fiscal Year 2006—$7,664,383
   Fiscal Years 2003–2005—$22,129,545
Total Funding to Date—$29,793,928

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

The purpose of this network is to establish (1) six to seven clinical centers to design and perform multiple therapeutic trials for treatment of patients with newly diagnosed idiopatic pulmonary fibrosis and (2) a Data Coordinating Center for the network.

Obligations

Funding History:
   Fiscal Year 2006—$7,349,196
   Fiscal Year 2005—$3,486,226
Total Funding to Date—$10,835,422

1. University of Nebraska Medical Center
   Omaha, Nebraska

2. Fred Hutchinson Cancer Research Center
   Seattle, Washington

3. Dana Farber Cancer Institute
   Boston, Massachusetts

4. Children’s Mercy Hospital
   Kansas City, Missouri

5. University of California, San Diego
   La Jolla, California

6. Duke University
   Durham, North Carolina

7. City of Hope Medical Center
   Duarte, California

8. University of Pennsylvania
   Philadelphia, Pennsylvania

9. University of Minnesota, Twin Cities
   Minneapolis, Minnesota

10. Stanford University
    Stanford, California

11. Medical College of Wisconsin
    Milwaukee, Wisconsin

12. University of Florida
    Gainesville, Floridas

13. Johns Hopkins University
    Baltimore, Maryland

14. Sloan Kettering Institute for Cancer Research
    New York, New York

15. University of Michigan at Ann Arbor
    Ann Arbor, Michigan

16. Case Western Reserve University
    Cleveland, Ohio

1. Children’s Research Institute
   Washington, DC

2. Duke University Medical Center
   Durham, North Carolina

3. Howard University
   Washington, DC

4. Johns Hopkins University
   Baltimore, Maryland

5. Medical University of South Carolina
   Charleston, South Carolina

6. St. Jude Children’s Research Hospital
   Memphis, Tennessee

7. The Research Foundation of SUNY
   New York, New York

8. University of Miami
   Miami, Florida

9. University of Mississippi Medical Center
   Jackson, Mississippi

10. University of Texas Southwestern Medical Center
    Dallas, Texas

11. Clinical Trials and Surveys Corporation
    Baltimore, Maryland

1. Duke University
   Durham, North Carolina

2. Emory University
   Atlanta, Georgia

3. Children’s Hospital and Research Center
   Oakland, California

4. Drexel University
   Philadelphia, Pennsylvania

5. New England Research Institutes, Inc.
   Watertown, Massachusetts

6. University of Illinois at Chicago
   Chicago, Illinois

7. Virginia Commonwealth University
   Richmond, Virginia

8. Children’s Hospital of Philadelphia
   Philadelphia, Pennsylvania

9. Howard University
   Washington, DC

10. Boston Medical Center
    Boston, Massachusetts

1. Rho Federal Systems Division, Inc.
   Chapel Hill, North Carolina

2. Imperial College of London
   London, England

3. Children’s Hospital of Pittsburgh
   Pittsburgh, Pennsylvania

4. University of Colorado
   Denver, Colorado

5. Children’s Hospital and Research Center at Oakland
   Oakland, California

6. University of Illinois at Chicago
   Chicago, Illinois

7. Johns Hopkins University
   Baltimore, Maryland

8. Howard University
   Washington, DC

9. Albert Einstein College of Medicine
   New York, New York

1. Children’s Hospital of Philadelphia
   Philadelphia, Pennsylvania

2. Hospital for Sick Children
   Toronto, Ontario

3. New England Research Institute, Inc.
   Watertown, Massachusetts

4. Children’s Hospital and Research Center at Oakland
   Oakland, California

5. Weill Medical College of Cornell University
   New York, New York

6. Children’s Hospital
   Boston, Massachusetts

1. University of Iowa
   Iowa City, Iowa

2. Case Western Reserve University
   Cleveland, Ohio

3. University of Minnesota, Twin Cities
   Minneapolis, Minnesota

4. Johns Hopkins University
   Baltimore, Maryland

5. Weill Medical College of Cornell University
   New York, New York

6. Emory University
   Atlanta, Georgia

7. New England Research Institutes, Inc.
   Watertown, Massachusetts

8. Tulane University of Louisiana
   New Orleans, Louisiana

9. University of Oklahoma Health Sciences Center
   Oklahoma City, Oklahoma

10. Duke University
    Durham, North Carolina

11. Blood Center of Southeastern Wisconsin
    Milwaukee, Wisconsin

12. Children’s Hospital
    Boston, Massachusetts

13. Massachusetts General Hospital
    Boston, Massachusetts

14. Puget Sound Blood Center
    Seattle, Washington

15. University of Pittsburgh
    Pittsburgh, Pennsylvania

16. University of Pennsylvania
    Philadelphia, Pennsylvania

17. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina

18. University of Maryland Baltimore Professional School
    Baltimore, Maryland

1. Fred Hutchinson Cancer Research Center
   Seattle, Washington

2. University of Medicine and Dentistry of New Jersey
   Newark, New Jersey

3. Fred Hutchinson Cancer Research Center
   Seattle, Washington

4. University of Minnesota, Twin Cities
   Minneapolis, Minnesota

5. University of Iowa College of Medicine
   Iowa City, Iowa

6. University of Alabama at Birmingham
   Birmingham, Alabama

7. Wake Forest University
   Winston-Salem, North Carolina

8. Northwestern University
   Chicago, Illinois

9. Brigham and Women’s Hospital
   Boston, Massachusetts

10. University of Medicine and Dentistry of New Jersey
    Newark, New Jersey

11. Emory University
    Atlanta, Georgia

12. University of Pittsburgh
    Pittsburgh, Pennsylvania

13. University of California, Davis
    Davis, California

14. University of Arizona
    Tucson, Arizona

15. University of Tennessee
    Memphis, Tennessee

16. Memorial Hospital of Rhode Island
    Pawtucket, Rhode Island

17. University of California, San Diego
    La Jolla, California

18. State University of New York at Buffalo
    Buffalo, New York

19. American College of Obstetricians and Gynecologists
    Washington, DC

20. University of California, Irvine
    Irvine, California

21. George Washington University
    Washington, DC

22. Stanford University
    Stanford, California

23. Baylor College of Medicine
    Houston, Texas

24. University of Texas Health Science Center
    San Antonio, Texas

25. Ohio State University
    Columbus, Ohio

26. University of Nevada School of Medicine
    Reno, Nevada

27. Kaiser Foundation Research Institute
    Oakland, California

28. State University of New York at Stony Brook
    Stony Brook, New York

29. University of Massachusetts Medical School
    Worcester, Massachusetts

30. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina

31. Wayne State University
    Detroit, Michigan

32. Albert Einstein College of Medicine
    New York, New York

33. Harbor-UCLA Research and Education Institute
    Torrance, California

34. Kaiser Foundation Research Institute
    Oakland, California

35. Medical College of Wisconsin
    Milwaukee, Wisconsin

36. Medlantic Research Institute
    Washington, DC

37. Rush-Presbyterian-St. Luke’s Medical Center
    Chicago, Illinois

38. University of California, Los Angeles School of Medicine
    Los Angeles, California

39. University of Cincinnati Medical Center
    Cincinnati, Ohio

40. University of Florida College of Medicine
    Gainesville, Florida

41. University of Hawaii at Manoa
    Honolulu, Hawaii

42. University of Miami
    Miami, Florida

43. University of Wisconsin
    Madison, Wisconsin