11. Clinical Trials

• NHLBI Investigator-Initiated Clinical Trials: Fiscal Years 2000–2010
• NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2010: Summary by Program
• Institute-Initiated Clinical Trials: Fiscal Years 2000–2010
• Institute-Initiated Clinical Trials, Fiscal Year 2010: 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 2000–2010

Research Grants and Cooperative Agreements (Dollars in Thousands)

*Paid by U01/U10.
**Previously an Institute-Initiated Clinical Trial.
^†  Formerly known as Bridging Anticoagulation on Patients Requiring Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial.
^‡    Formerly known as Pharmacomechanical Catheter-Directed Thrombolysis for Acute DVT–ATTRACT Trial.

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NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2010: 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.
^‡ Formerly known as Bridging Anticoagulation on Patients Requiring Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial.

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Institute-Initiated Clinical Trials: Fiscal Years 2000–2010

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.

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Institute-Initiated Clinical Trials, Fiscal Year 2010: Summary by Program

Contracts

* Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy.
Note: 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 Targeted Approaches to Weight Control for Young Adults.
**  Formerly known as Weight Loss in Obese Adults With Cardiovascular Risk Factors.

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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 multicenter, randomized clinical trial was to evaluate the ability of three treatment strategies (intensive glycemic control, intensive blood pressure control, and fibrate treatment to raise HDL-cholesterol and lower triglycerides) to prevent major cardiovascular events in adults who have type 2 diabetes mellitus and are at high risk for heart attack and stroke. The primary outcome measure was CVD mortality or major morbidity (MI and stroke). A total of 10,251 participants were recruited across 77 clinical sites in the United States and Canada. In February 2008, the glycemia trial was terminated early due to a higher mortality in the intensive glycemia treatment strategy compared with the standard treatment strategy. The lipid and blood pressure trials were continued, and interventions were stopped on June 30, 2009, for all participants.

Obligations

Funding History:
Fiscal Year 2010—$403,065
Fiscal Years 1999–2009—$142,184,481
Total Funding to Date—$142,587,546

Current Active Organizations and Contract Numbers

1. Veterans Affairs Medical Center, Albuquerque
   Albuquerque, New Mexico —HC-10100
2. Veterans Affairs Medical Center, Memphis
   Memphis, Tennessee —HC-90350
3. Wake Forest University
   Winston-Salem, North Carolina —HC-95178
4. McMaster University
   Hamilton, Ontario —HC-95179
5. University of Washington
   Seattle, Washington —HC-95180
6. Case Western Reserve University
   Cleveland, Ohio —HC-95181
7. Wake Forest University
   Winston-Salem, North Carolina —HC-95182
8. Minneapolis Medical Research Foundation
   Minneapolis, Minnesota —HC-95183
9. Trustees of Columbia University of New York
   New York, New York —HC-95184

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

The purposes of this study were 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. A high percentage of minorities participated in the study. 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.

Results were published in 2002 and 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. To answer additional scientific questions, a post-trial follow-up of participants through 2006 was conducted to obtain data on post-trial morbidity and mortality. The objective was 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 for the lipid component, to assess long-term effects of pravastatin compared with usual care.

Obligations

Funding History:
Fiscal Year 2010—$1,235,371
Fiscal Years 1993–2009—$83,170,059
Total Funding to Date—$84,405,430

Current Active Organization and Contract Number

1. University of Texas
   Health Science Center
   Houston, Texas —HC-35130

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 will provide 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 2010—$6,199,959
Fiscal Years 2007–2009—$18,219,368
Total Funding to Date—$24,419,327

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 non-overweight and overweight youth and to reduce weight in obese and severely obese youth. Two obesity prevention trials will develop and test approaches that target home, community, and primary care settings for preschool children living in low-income and ethnically diverse neighborhoods. Two obesity treatment trials will examine 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 2010—$4,058,435
Total Funding to Date—$4,058,435

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 is based on algorithms using clinical information and an individual's genotype using genes known to influence warfarin response ("genotype-guided dosing"), and the other is based on algorithms using only clinical information ("clinical-guided dosing"). Approximately 1,200 participants will be randomized over a 2-year period at 12 medical centers throughout the United States. The primary endpoint is anticoagulation control during the first month of therapy. The trial will assess anticoagulation control, bleeding problems and other complications, quality of life, and cost of therapy up to 6 months after initiation of therapy.

* Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy.

Obligations

Funding History:
Fiscal Year 2010—$0
Fiscal Years 2008–2009—$6,167,062
Total Funding to Date—$6,167,062

Current Active Organization and Contract Number

1. University of Pennsylvania
   Philadelphia, Pennsylvania —HV-88210

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 focus primarily on the out-of-hospital clinical emergency setting. To date, it has established an infrastructure of 245 emergency medical service (EMS) agencies and nearly 35,000 EMS providers that covers more than 22 million people throughout North America.

Obligations

Funding History:
Fiscal Year 2010—$6,243,690
Fiscal Years 2004–2009—$40,203,762
Total Funding to Date—$46,447,452

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

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

The purpose of this program is to develop and evaluate the effectiveness of culturally appropriate interventions to promote the adoption of healthy lifestyle behaviors to reduce CVD risk in American Indian/Alaska Native communities. Interventions focus on weight reduction, regular physical activity, and smoking cessation. A central feature of this project is to develop interventions that can be incorporated into clinical programs of the community health care system or delivered through public health approaches in Native communities.

Obligations

Funding History:
Fiscal Year 2010—$2,070,651
Fiscal Years 2006–2009—$8,882,655
Total Funding to Date—$10,953,306

Current Active Organizations and Grant Numbers

1. University of Washington
   Seattle, Washington —HL-087322
2. University of Oklahoma Health Sciences Center
   Oklahoma City, Oklahoma —HL-087354
3. University of Wisconsin—Madison
   Madison, Wisconsin —HL-087381
4. Black Hills Center/American Indian Health
   Rapid City, South Dakota —HL-087422

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 2010—$1,100,000
Fiscal Year 2009—$1,100,000
Total Funding to Date—$2,200,000

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, MD —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

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. During Phase I, researchers will refine proposed intervention, recruitment, retention, and adherence strategies. During Phase II, researchers will test the efficacy of the interventions that will 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.

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

Obligations

Funding History:
Fiscal Year 2010—$5,863,594
Fiscal Year 2009—$4,656,109
Total Funding to Date—$10,519,703

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. 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

Effectiveness Research on Smoking Cessation in Hospitalized Patients, Initiated in Fiscal Year 2010

The purposes of this study are to (a) evaluate the translation of efficacious smoking cessation strategies initiated during hospitalization and continued post-discharge into effective programs that can be widely implemented in routine clinical practice and (b) assess the cost effectiveness of the interventions.

Obligations

Funding History:
Fiscal Year 2010—$3,321,649
Total Funding to Date—$3,321,649

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

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 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 2010—$262,170
Fiscal Years 2006–2009—$29,194,950
Total Funding to Date—$29,457,120

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. 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 will monitor major cardiovascular events, such as heart attack, stroke, and cardiovascular-related death. Investigators will also examine 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 2010—$4,000,000
Fiscal Year 2009—$4,000,000
Total Funding to Date—$8,000,000

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 to ensure that the public has access to the best procedures. The Network will also serve as a clinical trials training ground for fellows and junior faculty.

Obligations

Funding History:
Fiscal Year 2010—$8,078,705
Fiscal Years 2007–2009—$17,900,101
Total Funding to Date—$25,978,806

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 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 2010—$7,471,016
Fiscal Years 2001–2009—$55,877,857
Total Funding to Date—$63,348,873

Current Active Organizations and Grant Numbers

1. Duke University "
   Durham, North Carolina —HL-068269
2. New England Research Institute, Inc.
   Watertown, Massachusetts —HL-068270
3. Children's Hospital of Philadelphia
   Philadelphia, Pennsylvania —HL-068279
4. Medical University of South Carolina
   Charleston, South Carolina —HL-068281
5. Children's Hospital
   Boston, Massachusetts —HL-068285
6. Hospital for Sick Children
   Toronto, Ontario —HL-068288
7. Columbia University Health Sciences
   New York, New York —HL-068290
8. University of Utah
   Salt Lake City, Utah —HL-068292
9. Children's Hospital Medical Center
   Cincinnati, Ohio —HL-085057

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 to (a) understand more fully the effect of HIV on sexual maturation, pubertal development, and socialization of perinatally HIV-infected preadolescents and adolescents and (b) acquire more definitive information about the long-term safety of antiretroviral agents when used during pregnancy and in newborns.

Obligations

Funding History:
Fiscal Year 2010—$0
Fiscal Years 2006–2009—$2,490,000
Total Funding to Date—$2,490,000

Current Active Organization and Contract Number

1. Harvard University
   Boston, Massachusetts —HD-052102

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

The purpose of this program 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. Unlike traditional multicenter clinical trials, each study functions as an independent trial with a distinct protocol, but efforts are made to coordinate and standardize several aspects of the trials. Forty-five to 100 percent of the participants are from racial and ethnic minority populations.

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

Obligations

Funding History:
Fiscal Year 2010—$2,329,121
Fiscal Years 2006–2009—$13,666,191
Total Funding to Date—$15,995,312

Current Active Organizations and Grant Numbers

1. Washington University
   St. Louis, Missouri —HL-087071
2. University of Pennsylvania
   Philadelphia, Pennsylvania —HL-087072
3. Johns Hopkins University
   Baltimore, Maryland —HL-087085

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 will reduce the risk of cardiovascular and kidney diseases or age-related cognitive decline. About 9,250 participants with systolic blood pressure ≥130 mm Hg will be recruited at approximately 90 clinics within 5 clinical center networks over 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 will focus on the effect of lowering systolic blood pressure to reduce the decline in cognitive function.

Obligations

Funding History:
Fiscal Year 2010—$29,374,119
Fiscal Year 2009—$7,508,288
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

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 will recruit up to 3,500 patients in Argentina, Brazil, Canada, Republic of Georgia, Russia, and the United States.

Obligations

Funding History:
Fiscal Year 2010—$897,950
Fiscal Years 2004–2009—$26,016,365
Total Funding to Date—$26,914,315

Current Active Organization and Contract Number

1. New England Research Institutes, Inc.
   Watertown, Massachusetts —HC-45207

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

The purpose of the WHI was to study cardiovascular disease, cancer, and osteoporosis in postmenopausal women. The program consisted of three major components: randomized controlled clinical trials 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.

In 2007, the WHI began a program to maximize the scientific yield from the biologic resources and associated participant exposure and outcome data from the study. The program seeks innovative technologies that will enable comprehensive investigation of sets of markers associated with disease outcomes or treatment effects, or of groups of mediators that might explain the pathway of exposure or treatment effects on disease outcomes.

Obligations

Funding History:
Fiscal Year 2010—$2,408,632
Fiscal Years 1992–2009^*—$790,662,086
Total Funding to Date—$793,070,018

* 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. Fred Hutchinson Cancer Research Center
   Seattle, Washington —WH-22110
2. University of Medicine and Dentistry of New Jersey
   Newark, New Jersey —WH-24152
3. Fred Hutchinson Cancer Research Center
   Seattle, Washington —WH-32100
4. University of Minnesota, Twin Cities
   Minneapolis, Minnesota —WH-32101
5. University of Iowa College of Medicine
   Iowa City, Iowa —WH-32102
6. University of Alabama at Birmingham
   Birmingham, Alabama —WH-32105
7. Wake Forest University
   Winston-Salem, North Carolina —WH-32106
8. Northwestern University
   Chicago, Illinois —WH-32108
9. Brigham and Women's Hospital
   Boston, Massachusetts —WH-32109
10. Emory University
    Atlanta, Georgia —WH-32111
11. University of Pittsburgh
    Pittsburgh, Pennsylvania —WH-32112
12. University of California, Davis
    Davis, California —WH-32113
13. University of Arizona
    Tucson, Arizona —WH-32115
14. University of Tennessee
    Memphis, Tennessee —WH-32118
15. Memorial Hospital of Rhode Island
    Pawtucket, Rhode Island —WH-32119
16. State University of New York at Buffalo
    Buffalo, New York —WH-32122
17. University of California, Irvine
    Irvine, California —WH-42107
18. George Washington University
    Washington, DC —WH-42108
19. Stanford University
    Stanford, California —WH-42109
20. Baylor College of Medicine
    Houston, Texas —WH-42110
21. University of Texas Health Science Center
    San Antonio, Texas —WH-42111
22. Ohio State University
    Columbus, Ohio —WH-42112
23. University of Nevada School of Medicine
    Reno, Nevada —WH-42113
24. Kaiser Foundation Research Institute
    Oakland, California —WH-42114
25. State University of New York at Stony Brook
    Stony Brook, New York —WH-42115
26. University of Massachusetts Medical School
    Worcester, Massachusetts —WH-42116
27. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina —WH-42117
28. Wayne State University
    Detroit, Michigan —WH-42118
29. Albert Einstein College of Medicine
    New York, New York —WH-42119
30. Harbor-UCLA Research and Education Institute
    Torrance, California —WH-42120
31. Kaiser Foundation Research Institute
    Oakland, California —WH-42121
32. Medical College of Wisconsin
    Milwaukee, Wisconsin —WH-42122
33. MedStar Research Institute
    Washington, DC —WH-42123
34. Rush-Presbyterian-St. Luke's Medical Center
    Chicago, Illinois —WH-42124
35. University of California, Los Angeles
    Los Angeles, California —WH-42125
36. University of Cincinnati Medical Center
    Cincinnati, Ohio —WH-42126
37. University of Florida College of Medicine
    Gainesville, Florida —WH-42129
38. University of Hawaii at Manoa
    Honolulu, Hawaii —WH-42130
39. University of Miami
    Miami, Florida —WH-42131
40. University of Wisconsin
    Madison, Wisconsin —WH-42132
41. Wake Forest University
    Winston-Salem, North Carolina —WH-44221
42. Albert Einstein College of Medicine
    New York, New York —WH-74310
43. Brigham and Women's Hospital
    Boston, Massachusetts —WH-74311
44. California Pacific Medical Center
    San Francisco, California —WH-74312
45. Fred Hutchinson Cancer Research Center
    Seattle, Washington —WH-74313
46. Fred Hutchinson Cancer Research Center
    Seattle, Washington —WH-74314
47. Fred Hutchinson Cancer Research Center
    Seattle, Washington —WH-74315
48. Ohio State University
    Columbus, Ohio —WH-74316
49. Tufts University
    Boston, Massachusetts —WH-74317
50. University of Pittsburgh
    Pittsburgh, Pennsylvania —WH-74318
51. University of California, Davis
    Davis, California —WH-74319
52. University of Pittsburgh
    Pittsburgh, Pennsylvania —WH-74320
53. Wake Forest University
    Winston-Salem, North Carolina —WH-74321
54. Ohio State University
    Columbus, Ohio —WH-94341
55. University of Pittsburgh
    Pittsburgh, Pennsylvania —WH-94342
56. Fred Hutchinson Cancer Research Center
    Seattle, Washington —WH-94343
57. Fred Hutchinson Cancer Research Center
    Seattle, Washington —WH-94344
58. Fred Hutchinson Cancer Research Center
    Seattle, Washington —WH-94346
59. Fred Hutchinson Cancer Research Center
    Seattle, Washington —WH-94347
60. Fred Hutchinson Cancer Research Center
    Seattle, Washington —WH-94348
61. Albert Einstein College of Medicine
    New York, New York —WH-94349
62. Brigham and Women's Hospital
    Boston, Massachusetts —WH-94350

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 2010—$7,207,532
Fiscal Years 1994–2009—$71,534,973
Total Funding to Date—$78,742,505

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 to address the most important asthma management questions and new treatment approaches in pediatric and adult populations. Investigators will identify optimal therapies for a variety of asthma phenotypes, genotypes, and racial and ethnic backgrounds. They will also conduct 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 2010—$15,500,000
Fiscal Year 2009—$8,300,000
Total Funding to Date—$23,800,000

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 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 2010—$3,150,000
Fiscal Years 2003–2009—$43,180,386
Total Funding to Date—$46,330,386

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 will be enrolled to determine whether supplemental oxygen can improve their quality of life and extend their lifespan. Research findings will help Medicare decide whether to extend coverage for home oxygen treatment for patients with moderately severe disease.

Obligations

Funding History:
Fiscal Year 2010—$4,334,914
Fiscal Years 2007–2009—$16,452,447
Total Funding to Date—$20,787,361

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
    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 that test novel interventions for a lung disease or a cardiopulmonary disorder from sleep. Investigators seek to identify interventions that will have the potential to significantly change clinical management.

Obligations

Funding History:
Fiscal Year 2010—$7,593,739
Total Funding to Date—$7,593,739

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. Brigham and Women's Hospital
   Boston, Massachusetts —HL-105371
6. Johns Hopkins University
   Baltimore, Maryland —HL-105569

Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS), Initiated in Fiscal Year 2009

The purposes of this study are to (a) define pathogenetically homogeneous subgroups of COPD subjects on the basis of biomarkers, genotypes, and computed tomography images and (b) identify immediate outcome measures for use in future clinical studies. Secondary aims are to clarify the natural history of COPD; develop bioinformatic resources that will enable the use and sharing of data in studies of COPD and related diseases; and create a collection of clinical, biomarker, radiographic, and genetic data that can be used by external investigators for other studies of COPD.

Obligations

Funding History:
Fiscal Year 2010—$27,960,468
Fiscal Year 2009—$2,081,851
Total Funding to Date—$30,042,319

Current Active Organizations and Contract Numbers

1. University of California, San Francisco
   San Francisco, California —HR-96199
2. University of California, Los Angeles
   Los Angeles, California —HR-96200
3. Columbia University
   New York, New York —HR-96201
4. University of Michigan at Ann Arbor
   Ann Arbor, Michigan —HR-96202
5. University of Utah
   Salt Lake City, Utah —HR-96203
6. Wake Forest University
   Winston-Salem, North Carolina —HR-96204
7. University of Iowa
   Iowa City, Iowa —HR-96205
8. University of North Carolina at Chapel Hill
   Chapel Hill, North Carolina —HR-96206

Blood Diseases and Resources Program

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

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

Obligations

Funding History:
Fiscal Year 2010—$2,507,421
Fiscal Years 2001–2009—$56,563,600
Total Funding to Date—$59,071,021

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. University of California, San Diego
   La Jolla, California —HL-069273
6. Duke University
   Durham, North Carolina —HL-069274
7. City of Hope Medical Center
   Duarte, California —HL-069278
8. University of Pennsylvania
   Philadelphia, Pennsylvania —HL-069286
9. University of Minnesota, Twin Cities
   Minneapolis, Minnesota —HL-069290
10. Stanford University
    Stanford, California —HL-069291
11. Medical College of Wisconsin
    Milwaukee, Wisconsin —HL-069294
12. University of Florida
    Gainesville, Florida —HL-069301
13. Johns Hopkins University
    Baltimore, Maryland —HL-069310
14. Sloan Kettering Institute for Cancer Research
    New York, New York —HL-069315
15. University of Michigan at Ann Arbor
    Ann Arbor, Michigan —HL-069330
16. University of Texas
    M.D. Anderson Cancer Center
    Houston, Texas —HL-069334
17. Case Western Reserve University
    Cleveland, Ohio —HL-069348

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 sickle cell anemia.

Obligations

Funding History:
Fiscal Year 2010—$0
Fiscal Years 2000–2009—$21,847,533
Total Funding to Date—$21,847,533

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, 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 will be 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.

Obligations

Funding History:
Fiscal Year 2010—$320,083
Fiscal Years 2006–2009—$9,333,094
Total Funding to Date—$9,653,177

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 promote the efficient comparison of 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 2010—$6,589,859
Fiscal Years 2002–2009—$50,450,201
Total Funding to Date—$57,040,060

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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