11. Clinical Trials

• NHLBI Investigator-Initiated Clinical Trials: Fiscal Years 2001–2011
• NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2011: Summary by Program
• Institute-Initiated Clinical Trials: Fiscal Years 2001–2011
• Institute-Initiated Clinical Trials, Fiscal Year 2011: Summary by Program
• Heart and Vascular Diseases
• Lung Diseases
• Blood Diseases and Resources

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 2001–2011

Research Grants and Cooperative Agreements (Dollars in Thousands)

*Paid by U01/U10.
**Previously an Institute-Initiated Clinical Trial.
^† Formerly known as Pharmacomechanical Catheter-Directed Thrombolysis for Acute DVT–ATTRACT Trial.

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NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2011: Summary by Program

* Paid by U01/U10.
** Previously an Institute-Initiated Clinical Trial.
^† Formerly known as Pharmacomechanical Catheter-Directed Thrombolysis for Acute DVT–ATTRACT Trial.

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Institute-Initiated Clinical Trials: Fiscal Years 2001–2011

Contracts

Dollars (Thousands)

* Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial.

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Cooperative Agreements

Dollars (Thousands)

^* Formerly known as Weight-Loss in Obese Adults With Cardiovascular Risk Factors.
^**  Formerly known as Targeted Approaches to Weight Control for Young Adults.
^† Investigator-Initiated from 1998 to 2002.
Note: The line labeled "Other Clinical Trials" ($78.8 million) that appeared in the FY 2010 Fact Book has been removed.

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Institute-Initiated Clinical Trials, Fiscal Year 2011: Summary by Program

Contracts

* Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy.
** From 1999 to 2006, the WHI was reported separately under its own major heading.  In this table, it is included in the Heart and Vascular Diseases section.  

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Cooperative Agreements

*  Formerly known as Effectiveness Research on Smoking Cessation in Hospitalized Patients.
** Formerly known as Targeted Approaches to Weight Control for Young Adults.

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Heart and Vascular Diseases

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

The purpose of this study was to compare the ability of a diuretic versus newer antihypertensive treatments (ACE inhibitor, calcium channel blocker, alpha blocker) to lower the combined incidence of fatal CHD and nonfatal MI in high-risk hypertensive patients and to determine whether lowering serum cholesterol with an HMG CoA reductase inhibitor reduced the total mortality in a subset of hypertensive patients with moderately elevated LDL cholesterol.

In February 2000, the alpha blocker arm of the study was discontinued because the CVD event rate was significantly greater among those patients compared with those in the control group. In 2002, results showed that diuretics work best to both lower blood pressure and prevent stroke and some forms of heart disease, including heart attack and heart failure.

Researchers are analyzing a post-trial follow-up (9–10 years) of participants to compare long-term effects of antihypertensive treatment with a thiazide-type diuretic, a calcium channel blocker, an ACE inhibitor, and an alpha receptor blocker when each drug was used as initial treatment, with step-up drugs added as needed, and for the lipid component, to assess long-term effects of pravastatin compared with usual care. Fifty-five percent of the participants are black.

Obligations

Funding History:
Fiscal Year 2011—$971,242
Fiscal Years 1993–2010—$84,405,430
Total Funding to Date—$85,376,672

Current Active Organization and Contract Number

1. University of Texas
   Health Science Center
   Houston, Texas —26820110036C

Cardiovascular Cell Therapy Research Network, Initiated in Fiscal Year 2007

The purpose of this program is to establish a research network to evaluate innovative cell therapy strategies for individuals with CVD. The network is providing the necessary infrastructure to develop, coordinate, and conduct multiple collaborative clinical protocols to facilitate application of emerging scientific discoveries to improve CVD outcomes.

Obligations

Funding History:
Fiscal Year 2011—$3,800,000
Fiscal Years 2007–2010—$24,419,327
Total Funding to Date—$28,219,327

Current Active Organizations and Grant Numbers

1. Case Western Reserve University
   Cleveland, Ohio —HL-087314
2. University of Texas
   Health Science Center
   Houston, Texas  —HL-087318
3. Texas Heart Institute
   Houston, Texas  —HL-087365
4. University of Florida
   Gainesville, Florida  —HL-087366
5. University of Minnesota, Twin Cities
   Minneapolis, Minnesota —HL-087394
6. Vanderbilt University
   Nashville, Tennessee —HL-087403

Childhood Obesity Prevention and Treatment Research (COPTR), Initiated in Fiscal Year 2010

The purpose of this research consortium is to test interventions to prevent excess weight gain in children and to reduce weight in obese children. Two obesity prevention trials are developing and testing approaches that target home, community, and primary care settings for preschool children living in low-income and ethnically diverse neighborhoods. Two obesity treatment trials are examining the therapies on overweight and obese children, 7- to 15-year olds, in school and home settings in collaboration with local youth organizations. More than 50 percent of the participants are expected to be from racial and ethnic minority populations.

Obligations

Funding History:
Fiscal Year 2011—$3,986,427
Fiscal Year 2010—$4,058,435
Total Funding to Date—$8,044,862

Current Active Organizations and Grant Numbers

1. University of North Carolina at Chapel Hill
   Chapel Hill, North Carolina   —HL-103561
2. Vanderbilt University School of Medicine
   Nashville, Tennessee —HL-103620
3. Case Western Reserve University
   Cleveland, Ohio  —HL-103622
4. Stanford University
   Palo Alto, California  —HL-103629

Clarification of Optimal Anticoagulation Through Genetics (COAG),* Initiated in Fiscal Year 2008

The purpose of this randomized, multicenter clinical trial is to compare two approaches to the initiation of warfarin therapy for optimal anticoagulation. One approach uses clinical information and an individual’s genotype based on the genes known to influence warfarin response (“genotype-guided dosing”), and the other uses only clinical information (“clinical-guided dosing”). Approximately 1,200 participants are being randomized over a 3-year period at 18 medical centers throughout the United States. The primary endpoint is anticoagulation control during the first month of therapy. The trial is assessing anticoagulation control, bleeding problems and other complications, quality of life, and cost of therapy up to 6 months after initiation of therapy.

Obligations

Funding History:
Fiscal Year 2011—$6,760,320
Fiscal Years 2008–2010—$6,167,062
Total Funding to Date—$12,927,382

Current Active Organization and Contract Number

1. University of Pennsylvania
   Philadelphia, Pennsylvania —26800800003C

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

The purpose of this program is to conduct research in cardiopulmonary arrest and severe traumatic injury to facilitate the rapid translation of promising scientific and clinical advances to improve resuscitation outcomes. The Consortium conducts multiple, collaborative clinical trials and studies that target primarily out-of-hospital clinical life compromising events, such as cardiac arrest and life threatening trauma.

Obligations

Funding History:
Fiscal Year 2011—$9,455,378
Fiscal Years 2004–2010—$46,447,452
Total Funding to Date—$55,902,830

Current Active Organizations and Grant Numbers

1. University of Washington
   Seattle, Washington   —HL-077863
2. Medical College of Wisconsin
   Milwaukee, Wisconsin —HL-077866
3. University of Washington
   Seattle, Washington  —HL-077867
4. University of Pittsburgh
   Pittsburgh, Pennsylvania  —HL-077871
5. St. Michael’s Hospital
   Toronto, Ontario  —HL-077872
6. Oregon Health and Science University
   Portland, Oregon  —HL-077873
7. University of Alabama at Birmingham
   Birmingham, Alabama —HL-077881
8. Ottawa Health Research Institute
   Ottawa, Ontario  —HL-077885
9. University of Texas
   Southwestern Medical Center
   Dallas, Texas  —HL-077887
10. University of California, San Diego
    La Jolla, California  —HL-077908

Consortium of Hospitals Advancing Research on Tobacco (CHART),** Initiated in Fiscal Year 2010

The purpose of this study is to evaluate the effectiveness of smoking cessation interventions in hospitalized patients. A network of six projects are assessing the effectiveness and cost effectiveness of smoking cessation interventions that are initiated during hospitalization and continued post-discharge in more than 10,000 hospitalized smokers across a geographically diverse group of nearly 20 private, public, academic, and community hospitals. Participation from minority populations is strong in some of the projects.

Obligations

Funding History:
Fiscal Year 2011—$3,505,096
Fiscal Year 2010—$3,321,649
Total Funding to Date—$6,826,745

*  Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy.
** Formerly known as Effective Research on Smoking Cessation in Hospitalized Patients.

Current Active Organizations and Grant Numbers

1. University of Michigan at Ann Arbor
   Ann Arbor, Michigan —HL-105218
2. New York University School of Medicine
   New York, New York —HL-105229
3. Kaiser Foundation Research Institute
   Oakland, California   —HL-105231
4. University of Kansas Medical Center
   Kansas City, Kansas —HL-105232
5. Kaiser Foundation Research Institute
   Oakland, California   —HL-105233
6. University of California, San Diego
   San Diego, California   —CA-159533
7. University of Alabama at Birmingham
   Birmingham, Alabama —DA-031515

Diabetes Prevention Program Outcomes Study—Phase II, Initiated in Fiscal Year 2009

The purpose of this multicenter clinical trial is to determine the efficacy of treatments to prevent or delay the development of type 2 diabetes in a population at high risk due to the presence of impaired glucose tolerance. The Phase II trial will continue to follow the original cohort to determine the long-term effects of the interventions (metformin versus lifestyle) on further diabetes development, microvascular outcomes, and CVD and CVD risk factors. Forty-five percent of participants are from diverse minority populations.

Obligations

Funding History:
Fiscal Year 2011—$1,100,000
Fiscal Years 2009–2010—$2,200,000
Total Funding to Date—$3,300,000

Current Active Organizations and Grant Numbers

1. University of Colorado
   Aurora, Colorado —DK-048375
2. Louisiana State University
   Pennington Biomedical Research Center
   Baton Rouge, Louisiana   —DK-048377
3. Northwestern University
   Chicago, Illinois —DK-048380
4. University of Chicago
   Chicago, Illinois —DK-048381
5. MEDSTAR Research Institute
   Hyattsville, Maryland —DK-048387
6. St. Luke’s Roosevelt Institute for Health Sciences
   New York, New York —DK-048404
7. Indiana University-Purdue
   University at Indianapolis
   Indianapolis, Indiana —DK-048406
8. University of New Mexico
   Albuquerque, New Mexico —DK-048407
9. University of Tennessee Health  Science Center
   Memphis, Tennessee —DK-048411
10. Seattle Institute for Biomedical and Clinical Research
    Seattle, Washington   —DK-048413
11. University of California, Los Angeles
    Los Angeles, California   —DK-048443
12. Thomas Jefferson University
    Philadelphia, Pennsylvania —DK-048468
13. Johns Hopkins University
    Baltimore, Maryland —DK-048485
14. George Washington University
    Washington, DC —DK-048489
15. University of Texas
    Health Science Center
    San Antonio, Texas   —DK-048514

Early Adult Reduction of Weight Through Lifestyle Intervention (EARLY) Trials,* Initiated in Fiscal Year 2009

*  Formerly known as Targeted Approaches to Weight Control for Young Adults.

The purpose of this program is to conduct two-phase clinical research to refine and test innovative behavioral approaches for weight control—using mobile phones, social networks, and Web-based curricula—in young adults, ages 18–35 years, who are at high risk for weight gain. Phase I involves refining proposed intervention, recruitment, retention, and adherence strategies. Phase II deals with testing the efficacy of the interventions that address weight loss, prevention of weight gain, or prevention of excessive weight gain during pregnancy. Targeted populations include pregnant and postpartum women, community college and university students, and young adults who are trying to quit smoking.

Obligations

Funding History:
Fiscal Year 2011—$6,123,513
Fiscal Years 2009–2010—$10,519,703
Total Funding to Date—$16,643,216

Current Active Organizations and Grant Numbers

1. University of Tennessee Health Science Center
   Memphis, Tennessee —HL-096628
2. University of California, San Diego
   La Jolla, California —HL-096715
3. 3. Duke University
   Durham, North Carolina   —HL-096720
4. Cornell University
   Ithaca, New York —HL-096760
5. University of Minnesota, Twin Cities
   Minneapolis, Minnesota   —HL-096767
6. University of Pittsburgh
   Pittsburgh, Pennsylvania —HL-096770

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 to improve outcomes through optimal application of existing therapies and evaluation of innovative therapies. The network provides 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 2011—$7,651,786
Fiscal Years 2006–2010—$37,108,888
Total Funding to Date—$44,760,674

Current Active Organizations and Grant Numbers

1. Minneapolis Medical Research Foundation, Inc.
   Minneapolis, Minnesota —HL-084861
2. Duke University
   Durham, North Carolina —HL-084875
3. Brigham and Women’s Hospital
   Boston, Massachusetts —HL-084877
4. University of Utah
   Salt Lake City, Utah —HL-084889
5. Baylor College of Medicine
   Houston, Texas  —HL-084890
6. Morehouse School of Medicine
   Atlanta, Georgia —HL-084891
7. University of Vermont and State Agriculture College
   Burlington, Vermont  —HL-084899
8. Duke University
   Durham, North Carolina —HL-084904
9. Mayo Clinic College of Medicine
   Rochester, Minnesota  —HL-084907
10. Montreal Heart Institute
    Montreal, Quebec, Canada —HL-084931

Look AHEAD: Action for Health in Diabetes, Initiated in Fiscal Year 2009

The purpose of this multicenter randomized clinical trial is to determine the effect of a lifestyle intervention—designed to achieve and maintain weight loss over the long term through decreased caloric intake and exercise—in obese individuals with type 2 diabetes. More than 5,000 participants have been randomly assigned to one of two interventions—either Lifestyle Intervention or Diabetes Support and Education—and will be followed for up to 11.5 years. The trial is monitoring major cardiovascular events, such as heart attack, stroke, and cardiovascular-related death. Investigators are also examining the impact of the interventions on other cardiovascular disease-related outcomes, cardiovascular risk factors, all-cause mortality, diabetes control and complications, fitness, general health, and health-related quality of life and psychological outcomes. One of the 16 clinical centers is targeting American Indians.

Obligations

Funding History:
Fiscal Year 2011—$4,000,000
Fiscal Years 2009–2010—$8,000,000
Total Funding to Date—$12,000,000

Current Active Organizations and Grant Numbers

1. University of Alabama at Birmingham
   Birmingham, Alabama   —DK-057008
2. University of Tennessee Health Science Center
   Memphis, Tennessee   —DK-057078
3. University of Pennsylvania
   Philadelphia, Pennsylvania —DK-057135
4. University of Colorado
   Denver, Colorado —DK-057151

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

The purpose of this program is to establish a network to evaluate newer surgical techniques, technologies, devices, and innovative pharmaceutical and bioengineered products directed at CVD. The Network conducts randomized clinical trials and clinical studies that provide a strong evidence base to inform surgical practice and disseminates its findings to the broader scientific community. The Network also serves as a clinical trials training ground for fellows and junior faculty.

Obligations

Funding History:
Fiscal Year 2011—$5,459,597
Fiscal Years 2007–2010—$25,978,806
Total Funding to Date—$31,438,403

Current Active Organizations and Grant Numbers

1. University of Virginia, Charlottesville
   Charlottesville, Virginia —HL-088925
2. Emory University
   Atlanta, Georgia —HL-088928
3. Albert Einstein College of Medicine of Yeshiva University
   Bronx, New York  —HL-088939
4. Columbia University Health Sciences
   New York, New York —HL-088942
5. Mount Sinai School of Medicine
   New York, New York —HL-088951
6. Duke University
   Durham, North Carolina —HL-088953
7. Case Western Reserve University
   Cleveland, Ohio  —HL-088955
8. University of Pennsylvania
   Philadelphia, Pennsylvania —HL-088957
9. Montreal Heart Institute
   Montreal, Quebec, Canada —HL-088963

Pediatric Heart Network, Initiated in Fiscal Year 2001

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

Obligations

Funding History:
Fiscal Year 2011—$12,827,177
Fiscal Years 2001–2009—$63,348,873
Total Funding to Date—$76,176,050

Current Active Organizations and Grant Numbers

1. New England Research Institute, Inc.
   Watertown, Massachusetts —HL-068270
2. Children’s Hospital Medical Center
   Cincinnati, Ohio —HL-109673
3. University of Michigan at Ann Arbor
   Ann Arbor, Michigan —HL-109737
4. Baylor College of Medicine
   Houston, Texas  —HL-109741
5. University of Utah
   Salt Lake City, Utah —HL-109743
6. Hospital for Sick Children
   Toronto, Ontario   —HL-109777
7. Medical University of South Carolina
   Charleston, South Carolina —HL-109778
8. Emory University
   Atlanta, Georgia —HL-109781
9. Children’s Hospital
   Boston, Massachusetts   —HL-109816
10. Children’s Hospital of Philadelphia
    Philadelphia, Pennsylvania —HL-109818

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

The purpose of this study is to create a body of data that will enable researchers to understand more fully the effects of HIV on sexual maturation, pubertal development, and socialization of perinatally HIV-infected preadolescents and adolescents and to acquire more definitive information about the long-term safety of antiretroviral agents when used during pregnancy and in newborns.

Obligations

Funding History:
Fiscal Year 2011—$600,000
Fiscal Years 2006–2010—$3,259,021
Total Funding to Date—$3,859,021

Current Active Organization and Contract Number

1. Harvard University
   Boston, Massachusetts —HD-052102

Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT), Initiated in Fiscal Year 2011

The purpose of this clinical feasibility study is to explore the potential benefit of mechanical circulatory support therapy using ventricular assist devices (VADs) in functionally-impaired advanced heart failure patients who have not yet developed serious consequences from their disease. The study will serve to inform a pivotal trial directed at a large and growing patient population for whom VADs could offer substantial benefit beyond current medical therapies.

Obligations

Funding History:
Fiscal Year 2011—$4,952,781
Total Funding to Date—$4,952,781

Current Active Organization and Contract Number:

1. University of Michigan at Ann Arbor
   Ann Arbor, Michigan  —268201100026C

Systolic Blood Pressure Intervention Trial (SPRINT), Initiated in Fiscal Year 2009

The purpose of this study is to determine whether intensive lowering of systolic blood pressure below the currently recommended standard reduces the risk of cardiovascular and kidney diseases or age-related cognitive decline. About 7,500 participants with systolic blood pressure ≥130 mm Hg are being recruited at more than 80 clinics in 5 clinical center networks during a 2-year period and will be followed for 4–6 years. Among the participants, approximately 4,300 will have chronic kidney disease and 3,250 will be aged 75 years and older. The primary endpoints are nonfatal MI, acute coronary syndrome, stroke, heart failure, or CVD mortality.  Secondary endpoints include decline in renal function or development of end stage renal disease. The MIND substudy is focusing on the effectiveness of lowering systolic blood pressure on reducing the decline in cognitive function.

Obligations

Funding History:
Fiscal Year 2011—$0
Fiscal Years 2009–2010—$36,882,407
Total Funding to Date—$36,882,407

Current Active Organizations and Contract Numbers

1. Wake Forest University Health Science Center
   Winston-Salem, North Carolina     —HC-95240
2. University of Utah
   Salt Lake City, Utah    —HC-95255
3. University of Birmingham
   Birmingham, Alabama  —HC-95256
4. Wake Forest University Health Science Center
   Winston-Salem, North Carolina    —HC-95257
5. Case Western Reserve University
   Cleveland, Ohio  —HC-95258
6. Department of Veterans Affairs, Memphis
   Memphis, Tennessee  —HV-0514

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

The purpose of this international randomized trial is to evaluate the effectiveness of spironolactone, a generic and inexpensive drug, to reduce cardiovascular mortality and heart failure hospitalization in patients who have heart failure with preserved systolic function (left ventricular ejection fraction ≥45 percent). The trial is recruiting up to 3,500 patients in Argentina, Brazil, Canada, Republic of Georgia, Russia, and the United States.

Obligations

Funding History:
Fiscal Year 2011—$0
Fiscal Years 2004–2010—$26,914,315
Total Funding to Date—$26,914,315

Current Active Organizations and Contract Numbers

1. HHS Program Support Center, Supply Service Center
   Perry Point, Maryland   —HC-4071
2. New England Research Institutes, Inc.
   Watertown, Massachusetts   —HC-45207

Women’s Health Initiative (WHI), Initiated in Fiscal Year 1992

The WHI was established to elucidate the etiology and prevention of CVD, cancers, and osteoporosis in women aged 50–79 years. The program consists of three primary components:  randomized controlled clinical trials of hormone therapy, 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. Total participation includes 161,808 women, for whom 17 percent are from minority populations.

Currently, investigators are determining the long-term effects of prior hormone therapy on the cohort that participated in the clinical trials of hormone therapy. Minority participants are being followed to improve statistical power for genetic association. Self-reported outcome data are being collected and will be available for ancillary studies and a new generation of clinical trials. The rich resources of data and specimens are available to the scientific community and for training young investigators.

Obligations

Funding History:
Fiscal Year 2011—$22,766,227
Fiscal Years 1992–2010*—$793,070,018
Total Funding to Date—$815,836,245

*  This figure reflects funding for the clinical trials and observational studies only. From 1992 to 1998, major support was provided through the Office of the Director, NIH. The Community Prevention Study receives funding through an inter-Agency agreement with the CDC:  $4,000,000 in FY 1999 and $12,000,000 from FY 1996–1998.

Current Active Organizations and Contract Numbers

1. State University of New York, Buffalo
   Buffalo, New York —268201100001
2. Ohio State University Research Foundation
   Columbus, Ohio   —268201100002
3. Stanford University
   Stanford, California —268201100003
4. Wake Forest University Health Sciences
   Winston-Salem, North Carolina —268201100004
5. Fred Hutchinson Cancer Research Center
   Seattle, Washington  —268201100046
6. Wake Forest University Health Sciences
   Winston-Salem, North Carolina —268200464221

Lung Diseases

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 and treat acute lung injury, ARDS, and other related critical illnesses and improve the outcome of patients with them.

Obligations

Funding History:
Fiscal Year 2011—$5,096,234
Fiscal Years 1994–2010—$78,742,505
Total Funding to Date—$83,838,739

Current Active Organizations and Contract Numbers

1. Baystate Medical Center
   Springfield, Massachusetts —HR-56165
2. University of California, San Francisco
   San Francisco, California —HR-56166
3. University of Colorado Health Sciences Center
   Denver, Colorado —HR-56167
4. Cleveland Clinic Lerner
   College of Medicine-Case Western Reserve University
   Cleveland, Ohio  —HR-56168
5. Duke University Medical Center
   Durham, North Carolina —HR-56169
6. Johns Hopkins University
   Baltimore, Maryland —HR-56170
7. LDS Hospital
   Salt Lake City, Utah  —HR-56171
8. Louisiana State University
   New Orleans, Louisiana —HR-56172
9. University of Washington
   Seattle, Washington —HR-56173
10. Vanderbilt University Medical Center
    Nashville, Tennessee —HR-56174
11. Wake Forest University Health Sciences
    Winston-Salem, North Carolina  —HR-56175
12. Mayo Clinic College of Medicine
    Rochester, Minnesota —HR-56176
13. Massachusetts General Hospital
    Boston, Massachusetts  —HR-56179

Asthma Network (AsthmaNet), Initiated in Fiscal Year 2009

The purpose of this network is to develop and conduct multiple clinical trials of asthma management in pediatric and adult populations.  Investigators are seeking to identify optimal therapies for a variety of asthma phenotypes, genotypes, and racial and ethnic backgrounds. They are also conducting a limited number of proof-of-concept studies to advance the development of innovative therapies and perform studies to investigate the mechanistic bases for the interventions. Approximately 30 percent of the participants will be from diverse minority populations.

Obligations

Funding History:
Fiscal Year 2011—$15,500,000
Fiscal Years 2009–2010—$23,800,000
Total Funding to Date—$39,300,000

Current Active Organizations and Grant Numbers

1. National Jewish Health
   Denver, Colorado —HL-098075
2. University of Wisconsin, Madison
   Madison, Wisconsin —HL-098090
3. Northwestern University
   Chicago, Illinois —HL-098096
4. Washington University
   St. Louis, Missouri —HL-098098
5. Brigham and Women’s Hospital
   Boston, Massachusetts —HL-098102
6. Wake Forest University Health Science Center
   Winston-Salem, North Carolina   —HL-098103
7. University of California, San Francisco
   San Francisco, California —HL-098107
8. University of Arizona
   Tucson, Arizona —HL-098112
9. Pennsylvania State University
   Hershey, Pennsylvania —HL-098115
10. University of Pittsburgh
    Pittsburgh, Pennsylvania  —HL-098177

COPD Clinical Research Network, Initiated in Fiscal Year 2003

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

Obligations

Funding History:
Fiscal Year 2011—$2,600,000
Fiscal Years 2003–2010—$46,330,386
Total Funding to Date—$48,930,386

Current Active Organizations and Grant Numbers

1. Harbor-UCLA Research and Education Institute
   Torrance, California  —HL-074407
2. Temple University
   Philadelphia, Pennsylvania —HL-074408
3. Denver Health and Hospital Authority
   Denver, Colorado  —HL-074409
4. Minnesota Veterans Research Institute
   Minneapolis, Minnesota —HL-074416
5. University of Alabama at Birmingham
   Birmingham, Alabama —HL-074418
6. University of Michigan at Ann Arbor
   Ann Arbor, Michigan —HL-074422
7. University of Minnesota, Twin Cities
   Minneapolis, Minnesota —HL-074424
8. Brigham and Women’s Hospital
   Boston, Massachusetts —HL-074428
9. University of California, San Francisco
   San Francisco, California —HL-074431
10. University of Pittsburgh
    Pittsburgh, Pennsylvania  —HL-074439
11. University of Maryland Baltimore Professional School
    Baltimore, Maryland —HL-074441

Long-Term Oxygen Treatment Trial (LOTT), Initiated in Fiscal Year 2007

The purpose of this program is to determine the effectiveness and safety of long-term oxygen therapy in patients with COPD. Approximately 1,100 patients with moderate COPD are being enrolled to determine whether supplemental oxygen can improve their quality of life and extend their lifespan. Research findings will help the Centers for Medicare and Medicaid Services decide whether to extend Medicare coverage for home oxygen treatment for patients with moderately severe disease.

Obligations

Funding History:
Fiscal Year 2011—$4,377,865
Fiscal Years 2007–2010—$20,787,361
Total Funding to Date—$25,165,226

Current Active Organizations and Contract Numbers

1. Brigham and Women’s Hospital
   Boston, Massachusetts  —HR-76183
2. Cleveland Clinic Foundation
   Cleveland, Ohio  —HR-76184
3. Denver Health and Hospital Authority
   Denver, Colorado —HR-76185
4. Duke University Medical Center
   Durham, North Carolina —HR-76186
5. Kaiser Foundation Hospitals
   Portland, Oregon  —HR-76187
6. Los Angeles Biomedical Institute/Harbor-UCLA
   Los Angeles, California  —HR-76188
7. Ohio State University
   Columbus, Ohio —HR-76189
8. Temple University
   Philadelphia, Pennsylvania —HR-76190
9. University of Alabama at Birmingham
   Birmingham, Alabama  —HR-76191
10. University of Michigan at Ann Arbor
    Ann Arbor, Michigan —HR-76192
11. University of Pittsburgh
    Pittsburgh, Pennsylvania  —HR-76193
12. University of Utah
    Salt Lake City, Utah  —HR-76194
13. University of Washington
    Seattle, Washington —HR-76195
14. Washington University
    St. Louis, Missouri —HR-76196
15. Johns Hopkins University
    Baltimore, Maryland —HR-76197

Novel Therapies for Lung Diseases—Phase II, Initiated in Fiscal Year 2010

The purpose of this study is to conduct proof-of-concept Phase II clinical trials of innovative interventions for a sleep-associated lung disease or a cardiopulmonary disorder. Investigators are seeking to identify interventions that will have the potential to improve clinical management.

Obligations

Funding History:
Fiscal Year 2011—$12,843,238
Fiscal Year 2010—$7,593,739
Total Funding to Date—$20,436,977

Current Active Organizations and Grant Numbers

1. Brigham and Women’s Hospital
   Boston, Massachusetts —HL-102225
2. University of Colorado Denver
   Aurora, Colorado  —HL-102235
3. University of Iowa
   Iowa City, Iowa —HL-102288
4. Fred Hutchinson Cancer Research Center
   Seattle, Washington —HL-102547
5. University of Wisconsin
   Madison, Wisconsin  —HL-105365
6. Brigham and Women’s Hospital
   Boston, Massachusetts —HL-105371
7. Johns Hopkins University
   Baltimore, Maryland —HL-105569
8. Mayo Clinic
   Rochester, Minnesota  —HL-108712
9. University of California, San Francisco
   San Francisco, California —HL-108713
10. Johns Hopkins University
    Baltimore, Maryland —HL-108730

Blood Diseases and Resources

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

The purpose of this network is to compare innovative treatment methods and management strategies of potential benefit for patients undergoing blood or marrow transplantation.

Obligations

Funding History:
Fiscal Year 2011—$5,319,784
Fiscal Years 2001–2010—$59,071,021
Total Funding to Date—$64,390,805

Current Active Organizations and Grant Numbers

1. University of Nebraska Medical Center
   Omaha, Nebraska —HL-069233
2. Fred Hutchinson Cancer Research Center
   Seattle, Washington —HL-069246
3. Dana Farber Cancer Institute
   Boston, Massachusetts —HL-069249
4. National Childhood Cancer Foundation
   Arcadia, California  —HL-069254
5. Duke University
   Durham, North Carolina —HL-069274
6. City of Hope Medical Center
   Duarte, California —HL-069278
7. University of Pennsylvania
   Philadelphia, Pennsylvania —HL-069286
8. University of Minnesota, Twin Cities
   Minneapolis, Minnesota —HL-069290
9. Stanford University
   Stanford, California  —HL-069291
10. Medical College of Wisconsin
    Milwaukee, Wisconsin —HL-069294
11. University of Florida
    Gainesville, Florida  —HL-069301
12. Johns Hopkins University
    Baltimore, Maryland —HL-069310
13. Sloan Kettering Institute for Cancer Research
    New York, New York —HL-069315
14. University of Michigan at Ann Arbor
    Ann Arbor, Michigan —HL-069330
15. University of Texas  MD Anderson Cancer Center
    Houston, Texas  —HL-069334
16. Case Western Reserve University
    Cleveland, Ohio  —HL-069348
17. Baylor College of Medicine
    Houston, Texas  —HL-108945
18. H. Lee Moffitt Cancer Center
    Tampa, Florida —HL-108987
19. Washington University
    St. Louis, Missouri —HL-109137
20. Ohio State University
    Columbus, Ohio —HL-109322
21. Northside Hospital Atlanta
    Atlanta, Georgia —HL-109526

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 preventing chronic end organ damage in pediatric patients with SCD.

Obligations

Funding History:
Fiscal Year 2011—$852,640
Fiscal Years 2000–2010—$21,847,533
Total Funding to Date—$22,700,173

Current Active Organizations and Contract Numbers

1. Children’s Research Institute
   Washington, DC —HB-07150
2. Duke University Medical Center
   Durham, North Carolina —HB-07151
3. Howard University
   Washington, DC —HB-07152
4. Johns Hopkins University
   Baltimore, Maryland —HB-07153
5. Medical University of South Carolina
   Charleston, South Carolina —HB-07154
6. St. Jude Children’s Research Hospital
   Memphis, Tennessee —HB-07155
7. The Research Foundation of SUNY
   New York, New York —HB-07156
8. University of Miami
   Miami, Florida  —HB-07157
9. University of Mississippi Medical Center
   Jackson, Mississippi —HB-07158
10. University of Texas Southwestern Medical Center
    Dallas, Texas —HB-07159
11. Clinical Trials and Surveys Corporation
    Baltimore, Maryland —HB-07160

Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension (walk PHaSST), Initiated in Fiscal Year 2006

The purpose of this clinical trial is to evaluate the safety and efficacy of 16 weeks of therapy with sildenafil, a nitric oxide potentiator, in adult patients with SCD and pulmonary hypertension. Exercise endurance and pulmonary artery pressure were measured. Pulmonary hypertension occurs in up to 30 percent of SCD cases and is strongly associated with mortality in adults with SCD. All of the participants are black.

The trial was stopped nearly 1 year early because the treatment group experienced either increased hospitalizations for sickle cell crises or severe pain compared with the control group. The follow-up study is using datasets and biorepository specimens from the closed trial to assess the effect of genetic factors on hematologic, cardiopulmonary, and pain phenotypes in individuals with hemoglobin SS disease and to explore phenotypic variations in individuals with hemoglobin SC disease.

Obligations

Funding History:
Fiscal Year 2011—$212,144
Fiscal Years 2006–2010—$9,653,177
Total Funding to Date—$9,865,321

Current Active Organizations and Contract Numbers

1. Rho Federal Systems Division, Inc.
   Chapel Hill, North Carolina  —HB-67182
2. Imperial College of London
   London, England —HB-67183
3. Children’s Hospital of Pittsburgh
   Pittsburgh, Pennsylvania  —HB-67184
4. University of Colorado
   Denver, Colorado —HB-67185
5. Children’s Hospital and Research Center at Oakland
   Oakland, California —HB-67186
6. University of Illinois at Chicago
   Chicago, Illinois  —HB-67187
7. Johns Hopkins University
   Baltimore, Maryland —HB-67188
8. Howard University
   Washington, DC —HB-67189
9. Albert Einstein College of Medicine of Yeshiva University
   New York, New York —HB-67190

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

The purpose of this network is to compare new management strategies for individuals with hemostatic disorders, such as idiopathic thrombocytopenia and thrombotic thrombocytopenic purpura, and evaluate new and existing blood products and cytokines for treatment of hematologic disorders.

Obligations

Funding History:
Fiscal Year 2011—$6,133,712
Fiscal Years 2002–2010—$57,040,060
Total Funding to Date—$63,173,772

Current Active Organizations and Grant Numbers

1. University of Iowa
   Iowa City, Iowa —HL-072028
2. Case Western Reserve University
   Cleveland, Ohio  —HL-072033
3. University of Minnesota, Twin Cities
   Minneapolis, Minnesota —HL-072072
4. Johns Hopkins University
   Baltimore, Maryland —HL-072191
5. Weill Medical College of Cornell University
   New York, New York —HL-072196
6. Emory University
   Atlanta, Georgia —HL-072248
7. New England Research Institutes, Inc.
   Watertown, Massachusetts —HL-072268
8. Tulane University of Louisiana
   New Orleans, Louisiana  —HL-072274
9. University of Oklahoma Health Sciences Center
   Oklahoma City, Oklahoma —HL-072283
10. Duke University
    Durham, North Carolina —HL-072289
11. Blood Center of Southeastern Wisconsin
    Milwaukee, Wisconsin —HL-072290
12. Children’s Hospital
    Boston, Massachusetts —HL-072291
13. Massachusetts General Hospital
    Boston, Massachusetts —HL-072299
14. Puget Sound Blood Center
    Seattle, Washington —HL-072305
15. University of Pittsburgh
    Pittsburgh, Pennsylvania  —HL-072331
16. University of Pennsylvania
    Philadelphia, Pennsylvania —HL-072346
17. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina —HL-072355
18. University of Maryland Baltimore
    Professional School
    Baltimore, Maryland —HL-072359

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