11. Clinical Trials

• NHLBI Investigator-Initiated Clinical Trials: Fiscal Years 2002–2012
• NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2012: Summary by Program
• Institute-Initiated Clinical Trials: Fiscal Years 2002–2012
• Institute-Initiated Clinical Trials, Fiscal Year 2012: 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 2002–2012

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 2012: 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 2002–2012

Contracts

Dollars (Thousands)

* Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial.
**  See Chapter 10 for preclinical PumpKIN R&D.

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Cooperative Agreements

Dollars (Thousands)

*    Formerly known as Clinical Research Consortium To Improve Resuscitation Outcome.
**   Correction to figure that was reported in the FY 2010 Fact Book.
^†     Formerly known as Weight Loss in Obese Adults With Cardiovascular Risk Factors.
^‡     Formerly known as Targeted Approaches to Weight Control for Young Adults.
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 2012: Summary by Program

Contracts

* Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy.
** See Chapter 10 for preclinical PumpKIN R&D. 

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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.
^†     Formerly known as Clinical Research Consortium To Improve Resuscitation Outcomes.

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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 2012—$973,725
Fiscal Years 1993–2011—$85,376,672
Total Funding to Date—$86,350,397

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 2012—$5,783,413
Fiscal Years 2007–2011—$28,219,327
Total Funding to Date—$34,002,740

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
7. Stanford University
   Menlo Park, California                                    —HL-113456
8. Indiana University
   Indianapolis, Indiana                                       —HL-113457
9. University of Miami
   Miami, Florida                                                   —HL-113460
10. University of Louisville
    Louisville, Kentucky                                         —HL-113530

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 2012—$7,527,535
Fiscal Years 2010–2011—$8,044,862
Total Funding to Date—$15,572,397

Current Active Organizations and Grant Numbers

1. University of North Carolina, 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

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

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"). 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 2012—$0
Fiscal Years 2008–2011—$12,927,382
Total Funding to Date—$12,927,382

Current Active Organization and Contract Number

1. University of Pennsylvania
   Philadelphia, Pennsylvania—268200800003C

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

**  Formerly known as Effective Research on Smoking Cessation in Hospitalized Patients. 

The purpose of this study is to evaluate the effectiveness of smoking cessation interventions in hospitalized patients. A network of six projects is assessing the effectiveness and cost effectiveness of smoking cessation interventions that are initiated during hospitalization and continued post-discharge. Participation from minority populations is strong in some of the projects. 

Obligations

Funding History:
Fiscal Year 2012—$4,933,114
Fiscal Years 2010–2011—$6,826,745
Total Funding to Date—$11,759,859

Current Active Organizations and Grant Numbers

1. University of Michigan
   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 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 is following 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 2012—$2,425,500
Fiscal Years 2009–2011—$3,300,000
Total Funding to Date—$5,725,500

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 Health 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
16. University of California, San Diego
    La Jolla, California                                           —DK-048339
17. Albert Einstein College of Medicine
    Bronx, New York                                              —DK-048349
18. Massachusetts General Hospital
    Boston, Massachusetts                                    —DK-048397
19. Washington University
    St. Louis, Missouri                                             —DK-048400
20. University of Pittsburgh
    Pittsburgh, Pennsylvania                                 —DK-048412
21. University of Miami
    Coral Gables, Florida                                        —DK-048434
22. Joslin Diabetes Center
    Boston, Massachusetts                                    —DK-048437

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 2012—$4,857,967
Fiscal Years 2009–2011—$16,643,216
Total Funding to Date—$21,501,183

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

EDTA Chelation Therapy for Coronary Artery Disease, Initiated in Fiscal Year 2009

The purpose of this multi-site, randomized trial is to determine the efficacy and safety of EDTA (ethylene diamine tetra-acetic acid) chelation therapy in individuals suffering from coronary artery disease. 

Obligations

Funding History
Fiscal Year 2012—$908,30
Fiscal Years 2009–2011—$2,109,044
Total Funding to Date—$3,017,346

Current Active Organization and Grant Number

1. Mount Sinai Medical Center
   Miami Beach, Florida—HL-092607

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. The network is developing, coordinating, and conducting multiple collaborative clinical protocols to facilitate application of emerging basic science discoveries into clinical investigations. 

Obligations

Funding History:
Fiscal Year 2012—$6,460,152
Fiscal Years 2006–2011—$44,760,674
Total Funding to Date—$51,220,826

Current Active Organizations and Grant Numbers

1. Duke University
   Durham, North Carolina—HL-084904
2. Mayo Clinic College of Medicine
   Rochester, Minnesota                                      —HL-110262
3. Thomas Jefferson University
   Philadelphia, Pennsylvania                             —HL-110297
4. Emory University
   Atlanta, Georgia                                                —HL-110302
5. Washington University
   St. Louis, Missouri                                             —HL-110309
6. Duke University
   Durham, North Carolina—HL-110312
7. Cleveland Clinic
   Cleveland, Ohio                                                 —HL-110336
8. Massachusetts General Hospital
   Boston, Massachusetts                                    —HL-110337
9. University of Pennsylvania
   Philadelphia, Pennsylvania                             —HL-110338
10. University of Vermont
    Burlington, Vermont                                         —HL-110342

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

The purpose of this multicenter randomized clinical trial is to determine the long-term effects 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. The lifestyle intervention group is being compared to a control group that is receiving diabetes support and education. One of the 16 clinical centers is targeting American Indians. 

Obligations

Funding History:
Fiscal Year 2012—$4,000,000
Fiscal Years 2009–2011—$12,000,000
Total Funding to Date—$16,000,000

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 2012—$7,097,239
Fiscal Years 2007–2011—$31,438,403
Total Funding to Date—$38,535,642

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 2012—$12,020,076
Fiscal Years 2001–2011—$76,176,050
Total Funding to Date—$88,196,126

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
   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 2012—$1,716,153
Fiscal Years 2006–2011—$3,859,021
Total Funding to Date—$5,575,174

Current Active Organization and Grant Number

1. Harvard University
   Boston, Massachusetts                                    —HD-052102

Pumps for Kids, Infants, and Neonates (PumpKIN), Initiated in Fiscal Year 2012

The purpose of this program is to explore the potential benefit of therapy offered by four novel pediatric circulatory support devices in infants, neonates, and young children (<25 kg) with congenital and acquired CVD who experience cardiopulmonary failure and circulatory collapse. The trials are intended to provide clinical evidence to be used in Humanitarian Device Exemption applications to the FDA for regulatory approval of the devices. 

Obligations

Funding History:
Fiscal Year 2012—$1,808,165
Total Funding to Date—$1,808,165

Current Active Organization and Contract Number

1. University of Pittsburgh
   Pittsburgh, PA                                           —268201000013C

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 2012—$0
Fiscal Year 2011—$4,952,781
Total Funding to Date—$4,952,781

Current Active Organization and Contract Number

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

Resuscitation Outcomes Consortium (ROC),* 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 severe trauma. 

Obligations

Funding History:
Fiscal Year 2012—$9,373,746
Fiscal Years 2004–2011—$55,902,830
Total Funding to Date—$65,276,576

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

*  Formerly known as Clinical Research Consortium To Improve Resuscitation Outcomes. 

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 dementia. 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 2012—$0
Fiscal Years 2009–2011—$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           —268200900040C
2. Case Western Reserve University
   Cleveland, Ohio                                       —268200900046C
3. University of Alabama at Birmingham
   Birmingham, Alabama                          —268200900047C
4. Wake Forest University Health
   Science Center
   Winston-Salem, North Carolina           —268200900048C
5. University of Utah
   Salt Lake City, Utah                               —268200900049C
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). Recruitment ended in 2012, with 3,445 patients from Argentina, Brazil, Canada, Republic of Georgia, Russia, and the United States. 

Obligations

Funding History:
Fiscal Year 2012—$2,824,999
Fiscal Years 2004–2011—$26,914,315
Total Funding to Date—$29,739,314

Current Active Organizations and Contract Numbers

1. HHS Program Support Center, Supply
   Service Center
   Perry Point, Maryland—HL-12025
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 consisted 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 included 161,808 women, 17 percent of whom were 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 2012—$21,909,919
Fiscal Years 1992–2011*—$815,836,945
Total Funding to Date—$837,746,164

*  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

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

The purpose of this network was to evaluate current and novel therapies and management strategies for adult asthma and to ensure that findings are rapidly disseminated to the medical community. The study has ended. 

Obligations

Funding History:
Fiscal Year 2012—$113,804
Fiscal Years 2003–2011—$42,901,101
Total Funding to Date—$43,014,905

Current Active Organization and Grant Number

1. University of California, San Diego
   La Jolla, California                                           —HL-074218

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 2012—$4,886,159
Fiscal Years 1994–2011—$83,838,739
Total Funding to Date—$88,724,898

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 to identify optimal therapies for a variety of asthma phenotypes, genotypes, and racial and ethnic backgrounds. Investigators 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 2012—$16,464,537
Fiscal Years 2009–2011—$39,300,000
Total Funding to Date—$55,764,537

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

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. 

Obligations

Funding History:
Fiscal Year 2012—$7,562,054
Fiscal Years 2007–2011—$25,165,226
Total Funding to Date—$32,727,280

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. Los Angeles Biomedical
   Institute/Harbor-UCLA
   Los Angeles, California                                      —HR-76188
6. Ohio State University
   Columbus, Ohio                                                  —HR-76189
7. Temple University
   Philadelphia, Pennsylvania                               —HR-76190
8. University of Alabama at Birmingham
   Birmingham, Alabama                                      —HR-76191
9. University of Michigan
   Ann Arbor, Michigan                                          —HR-76192
10. University of Pittsburgh
    Pittsburgh, Pennsylvania                                   —HR-76193
11. University of Utah
    Salt Lake City, Utah                                           —HR-76194
12. University of Washington
    Seattle, Washington                                            —HR-76195
13. Washington University
    St. Louis, Missouri                                               —HR-76196
14. 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 2012—$15,477,541
Fiscal Years 2010–2011—$20,436,977
Total Funding to Date—$35,914,518

Current Active Organizations and Grant Numbers

1. Brigham and Women's Hospital
   Boston, Massachusetts                                    —HL-102225
2. University of Iowa
   Iowa City, Iowa                                                —HL-102288
3. Fred Hutchinson Cancer Research Center
   Seattle, Washington                                          —HL-102547
4. University of Wisconsin
   Madison, Wisconsin                                         —HL-105365
5. Brigham and Women's Hospital
   Boston, Massachusetts                                    —HL-105371
6. Johns Hopkins University
   Baltimore, Maryland                                        —HL-105569
7. Mayo Clinic
   Rochester, Minnesota                                      —HL-108712
8. 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 2012—$4,051,982
Fiscal Years 2001–2011—$64,390,805
Total Funding to Date—$68,442,787

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
    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 2012—$8,501,196
Fiscal Years 2000–2011—$22,700,173
Total Funding to Date—$31,201,369

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

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 2012—$5,902,779
Fiscal Years 2002–2011—$63,173,772
Total Funding to Date—$69,076,551

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. Massachusetts General Hospital
    Boston, Massachusetts                                    —HL-072299
13. Puget Sound Blood Center
    Seattle, Washington                                          —HL-072305
14. University of Pittsburgh
    Pittsburgh, Pennsylvania                                 —HL-072331
15. University of Pennsylvania
    Philadelphia, Pennsylvania                             —HL-072346
16. University of North Carolina, Chapel Hill
    Chapel Hill, North Carolina                            —HL-072355
17. University of Maryland
    Baltimore Professional School
    Baltimore, Maryland                                        —HL-072359

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