« Factbook Table of Contents

11. Clinical Trials

• NHLBI Investigator-Initiated Clinical Trials: Fiscal Years 1997–2007
• NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2007:  Summary by Program
• Institute-Initiated Clinical Trials: Fiscal Years 1997–2007
• Institute-Initiated Clinical Trials, Fiscal Year 2007: 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 1997–2007

Research Grants and Cooperative Agreements (Dollars in Thousands)

* Paid by U01/U10.

Back to Top

NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2007:  Summary by Program

* Paid by U01/U10.

Back to Top

Institute-Initiated Clinical Trials:  Fiscal Years 1997–2007

Contracts

Dollars (Thousands)

Back to Top

Cooperative Agreements

Dollars (Thousands)

^*   Investigator-Initiated from 1998 to 2002.

Back to Top

Institute-Initiated Clinical Trials, Fiscal Year 2007:  Summary by Program

Contracts

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.

Back to Top

Cooperative Agreements

Back to Top

Heart and Vascular Diseases Program

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

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

Obligations

Funding History:
Fiscal Year 2007—$19,484,056
Fiscal Years 1999–2006—$90,895,802
Total Funding to Date—$110,379,858

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

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 treatment 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 2007—$4,424,183
Total Funding to Date—$4,424,183

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

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 2007—$8,971,584
Fiscal Years 2004–2006—$25,952,727
Total Funding to Date—$34,924,311

Current Active Organizations and Grant Numbers

1. University of Washington
   Seattle, Washington—HL-077863
2. University of Iowa
   Iowa City, Iowa—HL-077865
3. Medical College of Wisconsin
   Milwaukee, Wisconsin—HL-077866
4. University of Washington
   Seattle, Washington—HL-077867
5. University of Pittsburgh
   Pittsburgh, Pennsylvania—HL-077871
6. St. Michael’s Hospital
   Toronto, Ontario—HL-077872
7. Oregon Health and Science University
   Portland, Oregon—HL-077873
8. University of Alabama at Birmingham
   Birmingham, Alabama—HL-077881
9. Ottawa Health Research Institute
   Ottawa, Ontario—HL-077885
10. University of Texas
    Southwestern Medical Center
    Dallas, Texas—HL-077887
11. University of California, San Diego
    La Jolla, California—HL-077908

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 2007—$1,801,545
Fiscal Years 2005–2006—$3,755,350
Total Funding to Date—$5,556,895

Current Active Organizations and Contract Numbers

1. University of Pennsylvania
   Philadelphia, Pennsylvania—AI-063589
2. Mount Sinai School of Medicine
   New York, New York—AI-063594
3. Brigham and Women’s Hospital
   Boston, Massachusetts—AI-063623

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 will 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 2007—$2,314,003
Fiscal Year 2006—$1,418,746
Total Funding to Date—$3,732,749

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

Heart Failure Clinical Research Network, Initiated in Fiscal Year 2006

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

Obligations

Funding History:
Fiscal Year 2007—$7,800,582
Fiscal Year 2006—$5,642,461
Total Funding to Date—$13,443,043

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

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 determined by careful assessment. The Network will also serve as a clinical trials training ground for fellows and junior faculty.

Obligations

Funding History:
Fiscal Year 2007—$6,008,848
Total Funding to Date—$6,008,848

Current Active Organizations and Grant Numbers

1. University of Virginia, Charlottesville
   Charlottesville, Virginia—HL-088925
2. Emory University
   Atlanta, Georgia—HL-088928
3. Yeshiva University
   Bronx, New York—HL-088939
4. Columbia University Health Sciences
   New York, New York—HL-088942
5. Columbia University Health Sciences
   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 2007—$6,607,550
Fiscal Years 2001–2006—$29,578,646
Total Funding to Date—$36,186,196

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

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

Obligations

Funding History:
Fiscal Year 2007—$500,000
Fiscal Year 2006—$1,000,000
Total Funding to Date—$1,500,000

Current Active Organization and Grant Number

1. Harvard University
   Boston, Massachusetts—HD-052102

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 2007—$0
Fiscal Years 2000–2006—$34,211,102
Total Funding to Date—$34,211,102

Current Active Organizations and Grant Numbers

1. University of Minnesota, Twin Cities
   Minneapolis, Minnesota—HL-066845
2. University of South Carolina
   Columbia, South Carolina—HL-066852
3. University of North Carolina at Chapel Hill
   Chapel Hill, North Carolina—HL-066853
4. Tulane University
   New Orleans, Louisiana—HL-066855
5. San Diego State University
   San Diego, California—HL-066856
6. University of Maryland
   College Park, Maryland—HL-066857
7. University of Arizona
   Tucson, Arizona—HL-066858

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 2007—$2,217,724
Fiscal Years 2004–2006—$11,478,663
Total Funding to Date—$13,696,387

Current Active Organization and Contract Number

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

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

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

Obligations

Funding History:
Fiscal Year 2007—$3,713,946
Fiscal Year 2006—$2,567,146
Total Funding to Date—$6,281,092

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

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.

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 2007—$14,872,780
Fiscal Years 2000–2005^*—$722,565,555
Total Funding to Date—$737,438,335

*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 1996–98.

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. Medlantic Research Institute
    Washington, DC—WH-42123
34. Rush-Presbyterian-St. Luke’s Medical Center
    Chicago, Illinois—WH-42124
35. University of Cincinnati
    Medical Center
    Cincinnati, Ohio—WH-42126
36. University of Florida
    College of Medicine
    Gainesville, Florida—WH-42129
37. University of Hawaii at Manoa
    Honolulu, Hawaii—WH-42130
38. University of Miami
    Miami, Florida—WH-42131
39. University of Wisconsin
    Madison, Wisconsin—WH-42132
40. Wake Forest University
    Winston-Salem, North Carolina—WH-44221
41. Albert Einstein College of Medicine
    New York, New York—WH-74310
42. Brigham and Women’s Hospital
    Boston, Massachusetts—WH-74311
43. California Pacific Medical Center
    San Francisco, California—WH-74312
44. Fred Hutchinson Cancer Research Center
    Seattle, Washington—WH-74313
45. Fred Hutchinson Cancer Research Center
    Seattle, Washington—WH-74314
46. Fred Hutchinson Cancer Research Center
    Seattle, Washington—WH-74315
47. The Ohio State University
    Columbus, Ohio—WH-74316
48. Tufts University
    Boston, Massachusetts—WH-74317
49. University of Pittsburgh
    Pittsburgh, Pennsylvania—WH-74318
50. University of California, Davis
    Davis, California—WH-74319
51. University of Pittsburgh
    Pittsburgh, Pennsylvania—WH-74320
52. Wake Forest University
    Winston-Salem, North Carolina—WH-74321

Back to Top

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 2007—$5,036,653
Fiscal Years 1994–2006—$58,311,705
Total Funding to Date—$63,348,358

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

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

Obligations

Funding History:
Fiscal Year 2007—$8,917,879
Fiscal Years 2003–2006—$33,110,894
Total Funding to Date—$42,028,773

Current Active Organizations and Grant Numbers

1. National Jewish Medical and Research Center
   Denver, Colorado—HL-074073
2. University of California, San Francisco
   San Francisco, California—HL-074204
3. University of Texas Medical Branch
   Galveston, Texas—HL-074206
4. Washington University
   St. Louis, Missouri—HL-074208
5. University of Wisconsin
   Madison, Wisconsin—HL-074212
6. University of California, San Diego
   La Jolla, California—HL-074218
7. Wake Forest University Health Sciences
   Winston-Salem, North Carolina—HL-074225
8. Brigham and Women’s Hospital
   Boston, Massachusetts—HL-074227
9. Pennsylvania State University
   Hershey Medical Center
   Hershey, Pennsylvania—HL-074231

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 2007—$5,915,840
Fiscal Years 1999–2006—$42,837,293
Total Funding to Date—$48,753,133

Current Active Organizations and Grant Numbers

1. Washington University
   St. Louis, Missouri—HL-064287
2. National Jewish Medical and
   Research Center
   Denver, Colorado—HL-064288
3. University of California, San Diego
   La Jolla, California—HL-064295
4. University of Wisconsin
   Madison, Wisconsin—HL-064305
5. University of Arizona
   Tucson, Arizona—HL-064307
6. Pennsylvania State University
   Hershey, Pennsylvania—HL-064313

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 2007—$6,836,458
Fiscal Years 2003–2006—$29,793,928
Total Funding to Date—$36,630,386

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

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 2007—$7,216,255
Fiscal Years 2005–2006—$10,835,422
Total Funding to Date—$18,051,677

Current Active Organizations and Contract Numbers

1. Mayo Clinic College of Medicine
   Rochester, Minnesota—HL-080274
2. Vanderbilt University
   Nashville, Tennessee—HL-080370
3. University of Michigan at Ann Arbor
   Ann Arbor, Michigan—HL-080371
4. Weill Medical College of Cornell University
   New York, New York—HL-080383
5. University of California, Los Angeles
   Los Angeles, California—HL-080411
6. Duke University
   Durham, North Carolina—HL-080413
7. University of Washington
   Seattle, Washington—HL-080509
8. Tulane University of Louisiana
   New Orleans, Louisiana—HL-080510
9. University of Chicago
   Chicago, Illinois—HL-080513
10. Emory University
    Atlanta, Georgia—HL-080543
11. National Jewish Medical and
    Research Center
    Denver Colorado—HL-080571
12. University of California, San Francisco
    San Francisco, California—HL-080685

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, home-administered oxygen therapy in patients with COPD. Approximately 3,500 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 moderate disease.

Obligations

Funding History:
Fiscal Year 2007—$6,208,395
Total Funding to Date—$6,208,395

Current Active Organizations and Grant 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. The 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

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

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

Obligations

Funding History:
Fiscal Year 2007—$237,647
Fiscal Year 2006—$1,336,159
Total Funding to Date—$1,573,806

Current Active Organizations and Grant Numbers

1. Case Western Reserve University
   Cleveland, Ohio—HD-021364
2. University of Texas
   Health Science Center
   Houston, Texas—HD-021373
3. Wayne State University
   Detroit, Michigan—HD-021385
4. Emory University
   Atlanta, Georgia—HD-027851
5. Children’s Hospital Medical Center
   Cincinnati, Ohio—HD-027853
6. Indiana University-Purdue University
   at Indianapolis
   Indianapolis, Indiana—HD-027856
7. Yale University
   New Haven, Connecticut—HD-027871
8. Stanford University
   Stanford, California—HD-027880
9. Women and Infants Hospital
   Providence, Rhode Island—HD-027904
10. University of Alabama at Birmingham
    Birmingham, Alabama—HD-034216
11. University of California
    San Diego, California—HD-040461
12. Duke University
    Durham, North Carolina—HD-040492
13. University of Texas
    Southwestern Medical Center
    Dallas, Texas—HD-040689
14. University of New Mexico
    Albuquerque, New Mexico—HD-053089
15. University of Iowa
    Iowa City, Iowa—HD-053109
16. New England Medical Center Hospitals
    Boston, Massachusetts—HD-053119
17. University of Utah
    Salt Lake City, Utah—HD-053124

Back to Top

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 2007—$6,708,880
Fiscal Years 2001–2006—$36,486,721
Total Funding to Date—$43,195,601

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 the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.

Obligations

Funding History:
Fiscal Year 2007—$3,966,000
Fiscal Years 2000–2006—$10,604,399
Total Funding to Date—$14,570,399

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

Sickle Cell Disease Clinical Research Network, Initiated in Fiscal Year 2006

The purpose of this clinical research network is to conduct Phase III randomized controlled clinical trials to test the efficacy and effectiveness of new therapies to treat and prevent complications of SCD, and when appropriate, thalassemia. In addition, the network is designed to create data sets that can be used to improve characterization of patients and their clinical course, apply genomic and proteomic techniques for improved diagnostic and therapeutic approaches, and expand the clinical application of multimodal therapies in SCD.

Obligations

Funding History:
Fiscal Year 2007—$7,497,847
Fiscal Year 2006—$3,761,385
Total Funding to Date—$11,259,232

Current Active Organizations and Contract Numbers

1. Duke University
   Durham, North Carolina—HL-083698
2. Emory University
   Atlanta, Georgia—HL-083699
3. Children’s Hospital and Research Center
   Oakland, California—HL-083704
4. Drexel University
   Philadelphia, Pennsylvania—HL-083705
5. New England Research Institutes, Inc.
   Watertown, Massachusetts—HL-083721
6. University of Illinois at Chicago
   Chicago, Illinois—HL-083730
7. Virginia Commonwealth University
   Richmond, Virginia—HL-083732
8. Children’s Hospital of Philadelphia
   Philadelphia, Pennsylvania—HL-083746
9. Howard University
   Washington, DC—HL-083748
10. Boston Medical Center
    Boston, Massachusetts—HL-083771

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 18 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.

Obligations

Funding History:
Fiscal Year 2007—$2,801,174
Fiscal Year 2006—$1,867,000
Total Funding to Date—$4,668,174

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
   New York, New York—HB-67190

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 2007—$2,618,369
Fiscal Years 2000–2006—$16,787,170
Total Funding to Date—$19,405,539

Current Active Organizations and Grant Numbers

1. Children’s Hospital of Philadelphia
   Philadelphia, Pennsylvania—HL-065232
2. Hospital for Sick Children
   Toronto, Ontario—HL-065233
3. New England Research Institute, Inc.
   Watertown, Massachusetts—HL-065238
4. Children’s Hospital and Research
   Center at Oakland
   Oakland, California—HL-065239
5. Weill Medical College of Cornell University
   New York, New York—HL-065244
6. Children’s Hospital
   Boston, Massachusetts—HL-065260

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 to evaluate new and existing blood products and cytokines for treatment of hematologic disorders.

Obligations

Funding History:
Fiscal Year 2007—$6,407,000
Fiscal Years 2002–2006—$31,128,254
Total Funding to Date—$37,535,254

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

Back to Top

« Factbook Table of Contents

HOME · SEARCH · ACCESSIBILITY · SITE INDEX · OTHER SITES · PRIVACY STATEMENT · FOIA · CONTACT US