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11. Clinical Trials

• NHLBI Investigator-Initiated Clinical Trials: Fiscal Years 1995–2005
• NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2005: Summary by Program
• Institute-Initiated Clinical Trials: Fiscal Years 1995–2005
  • Contracts
  • Cooperative Agreements
• Institute-Initiated Clinical Trials, Fiscal Year 2005: Summary by Program
  • Contracts
  • Cooperative Agreement

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 1995–2005

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

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

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NHLBI Investigator-Initiated Clinical Trials: Fiscal Years 1995–2005

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

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Institute-Initiated Clinical Trials: Fiscal Years 1995–2005

Contracts

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Institute-Initiated Clinical Trials: Fiscal Years 1995–2005 (continued)

Cooperative Agreements

* Investigator-Initiated from 1998 to 2002.

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Institute-Initiated Clinical Trials, Fiscal Year 2005: Summary by Program

Contracts

Cooperative Agreements

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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 2005—$26,126,324
   Fiscal Years 1999–2004—$64,769,478
Total Funding to Date—$90,895,802

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Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT), Initiated in Fiscal Year 1993

The ALLHAT is a practice-based, randomized clinical trial to determine whether combined incidence of fatal CHD and nonfatal MI differs between diuretic-based and newer antihypertensive treatments (ACE inhibitor, calcium channel blocker, alpha blocker) in high-risk hypertensive patients. The objective of the lipid-lowering component of the study is to determine whether lowering serum cholesterol with an HMG CoA reductase inhibitor reduces the total mortality in a subset of hypertensive patients with moderately elevated LDL cholesterol. Because blacks and Hispanics are at high risk for hypertension and CHD, investigators recruited a high percentage of minorities into the study.

In February 2000, the alpha blocker arm of the study was discontinued at the recommendation of the Data Safety Monitoring Committee and an independant expert review committee because the CVD event rate was significantly greater among those patients compared to the control group.

Obligations

Funding History:
   Fiscal Year 2005—$0
   Fiscal Years 1993–2004—$83,170,059
Total Funding to Date—$83,170,059

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

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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 2005—$1,900,000
Total Funding to Date—$1,900,000

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 2005—$0
   Fiscal Year 2004—$1,009,694
Total Funding to Date—$1,009,694

Pediatric Cardiovascular Clinical Research Network, Initiated in Fiscal Year 2001

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 2005—$3,992,212
   Fiscal Years 2001–2004—$18,598,211
Total Funding to Date—$22,590,423

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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 2005—$5,102,829
   Fiscal Years 2000–2004—$28,202,937
Total Funding to Date—$33,305,766

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 2005—$5,161,746
   Fiscal Year 2004—$837,227
Total Funding to Date—$5,998,973

Lung Diseases Program

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

The objective of this network is to test new therapeutic agents with a potential for improving the outcome of patients with ARDS and those at risk of developing ARDS.

Obligations

Funding History:
   Fiscal Year 2005—$4,706,675
   Fiscal Years 1994–2004—$46,208,966
Total Funding to Date—$50,915,641

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Asthma Clinical Research Network (ACRN), 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 2005—$8,667,026
   Fiscal Years 2003–2004—$16,605,558
Total Funding to Date—$25,272,584

Childhood Asthma Management Program (CAMP), Initiated in Fiscal Year 1991

The purpose of this study is to evaluate the long-term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyper-responsiveness, and on physical and psychosocial growth and development. Results showed that 4 ½ to 6 years of daily treatment with inhaled corticosteroids was safe and provided superior control of asthma compared to a different anti-inflammatory medication or treatment only when symptoms occurred. The CAMP study will continue to observe the children for 5 years to determine the effect of early treatment on maximum lung growth and on height.

Obligations

Funding History:
   Fiscal Year 2005—$599,206
   Fiscal Years 1991–2004—$56,320,611
Total Funding to Date—$56,919,817

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 2005—$5,704,202
   Fiscal Years 1999–2004—$31,398,337
Total Funding to Date—$37,102,539

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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 2005—$8,437,795
   Fiscal Years 2003–2004—$13,691,750
Total Funding to Date—$22,129,545

Feasibility of Retinoid Treatment in Emphysema (FORTE), Initiated in Fiscal Year 1999

The purpose of this program is to conduct preliminary studies to identify optimal patient populations, drugs and dosing schedules, and outcome measures before conducting a larger clinical trial on retinoid treatment for emphysema.

Obligations

Funding History:
   Fiscal Year 2005—$185,012
   Fiscal Years 1999–2004—$12,256,041
Total Funding to Date—$12,441,053

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 2005—$3,486,226
Total Funding to Date—$3,486,226

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National Emphysema Treatment Trial (NETT), Initiated in Fiscal Year 1997

The NETT is a multicenter trial designed to evaluate the efficacy and role of lung volume reduction surgery (a procedure in which part of the lung is removed in an attempt to improve breathing) in the treatment of severe emphysema. If surgery proves to be effective, a major secondary objective is to determine which patients are most likely to benefit.

Obligations

Funding History:
   Fiscal Year 2005—$357,270
   Fiscal Years 1997–2004—$35,846,310
Total Funding to Date—$36,203,580

Blood Diseases and Resources Program

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

The purpose of this network is to promote the efficient comparison of novel treatment methods and management strategies of potential benefit for children and adults undergoing blood or marrow transplantation.

Obligations

Funding History:
   Fiscal Year 2005—$6,459,743
   Fiscal Years 2001–2004—$23,181,808
Total Funding to Date—$29,641,551

Cord Blood Stem Cell Transplantation Study (COBLT), Initiated in Fiscal Year 1996

The purpose of this multicenter study is to determine whether umbilical cord blood stem cell transplants from unrelated, newborn donors are a safe and efficient alternative to bone marrow transplantation for children and adults with a variety of cancers, blood diseases, and genetic disorders.

Obligations

Funding History:
   Fiscal Year 2005—$822,243
   Fiscal Years 1996–2004—$32,406,365
Total Funding to Date—$33,228,608

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Multicenter Study of Hydroxyurea (MSH) in Sickle Cell Anemia Adult Follow-up, Initiated in Fiscal Year 1996

The purpose of this trial is to determine the long-term effects of hydroxurea. Patients were examined annually to determine their health status, quality of life, incidence of malignancies, and birth defects in their offspring(s). Mortality rates from this cohort were compared to mortality data from the CSSCD cohort and the normal black population mortality. Results showed that patients who took hydroxyurea over a 9-year period experienced a 40 percent reduction in deaths. Improved survival was related to benefits of drug therapy—an increase in fetal hemoglobin level and reduced episodes of severe pain “crises” and acute chest syndrome.

Obligations

Funding History:
   Fiscal Year 2005—$1,340,090
   Fiscal Years 1996–2004—$4,836,836
Total Funding to Date—$6,176,926

Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG), Initiated in Fiscal Year 2000

The objective of this clinical trial is to determine if hydroxyurea therapy is effective in prevention of chronic end organ damage in pediatric patients with sickle cell anemia.

Obligations

Funding History:
   Fiscal Year 2005—$1,526,201
   Fiscal Years 2000–2004—$8,187,198
Total Funding to Date—$9,713,399

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

The purpose of this network is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers.

Obligations

Funding History:
   Fiscal Year 2005—$2,729,989
   Fiscal Years 2000–2004—$11,374,688
Total Funding to Date—$14,104,677

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

The purpose of this network is to promote the efficient comparison of new management strategies for individuals with hemostatic disorders, such as idiopathic throm-bocytopenia and thrombotic thrombocytopenic purpura, and to evaluate new and existing blood products and cytokines for treatment of hematologic disorders.

Obligations

Funding History:
   Fiscal Year 2005—$6,221,140
   Fiscal Years 2002–2004—$18,386,476
Total Funding to Date—$24,607,616

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Women’s Health Initiative, Initiated in Fiscal Year 1992

The purpose of the WHI is to study cardiovascular disease, cancer, and osteoporosis in postmenopausal women. The program consists of three major components: a randomized controlled clinical trial of HRT, dietary modification, and calcium/vitamin D supplementation; an observational study to identify predictors of disease; and a study of community approaches to developing healthful behaviors.

Obligations

Funding History:
   Fiscal Year 2005—$37,826,017
   Fiscal Years 2000–2004*—$672,615,477
Total Funding to Date—$710,441,494

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