11. Clinical Trials


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)

 

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

FY 2008

FY 2009

FY 2010

Heart and Vascular Diseases

 

 

 

 

 

 

 

 

 

 

 

Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest

$   392

$  75

$  —

$  —

$  —

$  —

$  —

 $  —

$  —

$  —

$  —

Women's Health Study (WHS)

1,594

889

868

875

919

927

Women's Antioxidant and Cardiovascular Study (WACS)

556

572

598

592

599

670

Stress Reduction and Atherosclerotic CVD in Blacks

339

360

376

394

Shock Trial: Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock?

440

362

298

291

296

HDL-Atherosclerosis Treatment Study

326

Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)*

32

Mode Selection Trial in Sinus Node Dysfunction (MOST)*

1,136

154

Estrogen and Graft Atherosclerosis Research Trial (EAGER)*

361

371

REMATCH Trial*

825

750

Dietary Patterns, Sodium Intake, and Blood Pressure (DASH Sodium)* **

1,247

151

387

376

395

Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)*

1,698

1,798

1,412

1,930

CVD Risk and Health in Post-Menopausal Phytoestrogen Users

244

304

152

Treatment of Hypertension With Two Exercise Intensities

481

420

Prevention of Recurrent Venous
Thromboembolism (PREVENT)

521

543

1,272

PREMIER: Lifestyle Interventions for Blood Pressure Control*

3,595

2,925

1,505

Azithromycin and Coronary Events Study (ACES)*

2,182

720

1,254

1,137

Antiarrhythmic Effects of N-3 Fatty Acids

542

529

647

Fatty Acid Antiarrhythmia Trial (FAAT)

605

Occluded Artery Trial (OAT)*

5,079

2,604

1,724

1,963

963

1,452

1,277

1,270

1,033

Bypass Angioplasty Revascularization
Investigation in Type 2 Diabetics
(BARI 2D)*

3,942

6,515

9,342

8,189

8,265

8,304

8,592

2,647

1,971

1,130

Hematocrit Strategy in Infant Heart Surgery*

473

557

596

590

492

Angiotensin-II Blockade in Mitral
Regurgitation

553

610

629

500

Heart Failure Adherence and Retention Trial (HART)

795

1,617

1,453

1,174

862

740

304

Reduction of Triglycerides in Women on HRT

708

746

555

544

721

625

501

Women's Ischemia Syndrome Evaluation (WISE)* **

1,502

1,506

1,306

1,303

996

ACE Inhibition and Novel Cardiovascular Risk Factors

694

656

602

Heart Failure: A Controlled Trial
Investigating  Outcomes of Exercise
(HF-ACTION)*

7,471

9,582

7,973

4,483

4,590

2,846

652

Clinical Trial of Dietary Protein on Blood Pressure

655

610

612

504

500

Home Automatic External Defibrillator Trial (HAT)*

3,567

5,433

4,264

1,801

2,115

Perioperative Interventional Neuroprotection Trial (POINT)

553

553

562

572

378

Stop Atherosclerosis in Native Diabetics
Study (SANDS)*

2,410

2,165

2,107

2,324

2,074

197

218

Surgical Treatment for Ischemic Heart Failure (STICH)*

5,709

4,495

1,613

6,082

5,583

9,396

3,639

727

1,233

Girls Health Enrichment Multisite Studies (GEMS)*

2,461

2,400

2,369

1,950

Treatment of Depression Following Bypass Surgery

964

1,132

1,181

1,193

885

Weight Loss Maintenance (WLM)*

3,687

4,368

3,099

4,015

2,151

145

150

Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)*

4,343

5,610

4,884

3,307

3,269

4,414

FREEDOM Trial: Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optional Management of  Multivessel Disease

3,663

4,669

5,180

2,818

1,658

3,429

IMMEDIATE Trial: Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency  Care*

5,170

9,514

10,966

AIM HIGH: Niacin Plus Statin To Prevent  Vascular Events*

663

6,324

6,018

1,380

2,324

6,927

Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)*

1,368

1,478

1,898

1,822

1,080

Interventions To Control Obesity in College

677

633

670

686

588

PACEmaker and Beta-Blocker Therapy Post-Myocardial Infarction (PACE-MI)

1,300

4,555

384

Efficacy of Smoking Quit Line in the Military

739

720

731

Vest prevention of Early Sudden Death Trial (VEST) and PREDiction of ICd Therapies Studies (PREDICTS)*

1,390

1,356

1,391

1,404

Planned Care for Obesity and Risk Reduction (Planned CORR)

784

770

769

Effects of Niacin on Lp(a), Oxidized LDL, and Inflammation on the AIM-HIGH Trial

302

312

383

Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction

776

742

745

Rule-Out Myocardial Infarction Using Computer Assisted Tomography (ROMICAT II)*

2,112

2,307

Collaborative Model To Improve BP Control and Minimize Racial Disparities

1,963

1,938

Multiscale Model of the Human Heart for Imaging Research

566

503

Catheter Ablation Versus Antiarrythmic Drug Therapy for Atrial Fibrillation (CABANA)*

2,941

3,045

Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA)*

3,648

2,285

Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA)*

3,648

2,285

Vitamin D and Omega 3 Trial (VITAL)*

1,260

1,248

Late  Sodium Blockade in High-Risk ICD Patients*

2,280

Subtotal, Heart and Vascular Diseases

26,578

22,996

45,253

50,163

52,377

56,681

58,312

45,091

21,737

27,122

36,538

Lung Diseases

 

 

 

 

 

 

 

 

 

 

 

Lung Health Study III* **

1,616

1,672

927

Asthma Clinical Research Network (ACRN)* **

5,686

5,705

5,863

Fetal Tracheal Occlusion for Severe  Diaphragmatic Hernia*

429

181

Scleroderma Lung Study*

1,501

1,761

1,501

1,055

71

Inhaled Nitric Oxide for Prevention of  Chronic Lung Disease*

1,959

1,803

1,764

1,442

1,245

Inhaled Nitric Oxide in Prevention of Chronic Lung Disease*

1,548

1,742

1,839

1,604

903

Prospective Investigation of Pulmonary  Embolism Diagnosis II (PIOPED II)*

2,190

3,667

3,388

472

Randomized Trial To Reduce ETS in Children With Asthma

555

545

468

277

Apnea Positive Pressure Long-Term Efficacy Study (APPLES)*

3,224

3,021

3,110

3,188

1,532

Childhood Asthma Management Program-Continuation Study (CAMP-CS)/Phase II* **

1,489

2,043

2,623

2,750

Acid Reflux Therapy in Asthma*

736

783

791

773

662

Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)

682

612

608

694

Outcomes of Sleep Disorders in Older Men

4,163

4,262

1,390

1,142

910

Supplemental Selenium and Vitamin E and Pulmonary Function

698

610

630

605

561

Improving Asthma Care in Minority Children in Head Start

721

826

1,004

779

Randomized Controlled Study of Adenotonsillectomy for Childhood Sleep Apnea

2,255

2,388

1,346

2,501

1,675

Supplemental Selenium and Vitamin E and Pulmonary Function

698

610

630

605

561

Improving Asthma Care in Minority Children in Head Start

721

826

1,004

779

Randomized Controlled Study of Adenotonsillectomy for Childhood Sleep Apnea

2,255

2,388

1,346

2,501

1,675

Early Insulin Therapy and Development of ARDS

489

454

464

417

Childhood Asthma Management Program—Continuation Study (CAMP-CS)/Phase III* **

2,077

1,966

1,146

2,065

Infant Study of Inhaled Saline in Cystic Fibrosis (ISIS)*

732

737

776

Scleroderma Lung Study II

2,281

2,297

2,252

Sedation Management in Pediatric Patients With Acute Respiratory Failure*

568

3,885

3,327

Study of Asthma and Nasal Steroids (STAN)*

725

725

Outpatient Treatment of Low-Risk Patients With Pulmonary Embolism

755

349

Translating COPD Guidelines Into Primary Care Practice

733

719

Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans

225

187

Physical Activity Self-Management in Patients With COPD

663

660

Study of Soy Isoflavones in Asthma (SOYA)*

775

697

Trial of Late Surfactant To Prevent Bronchopulmonary Dysplasia (TOLSURF)*

1,987

1,779

Randomized Trial of Maternal Vitamin D Supplementation To Prevent Childhood Asthma*

2,510

2,466

Effects of HIV Antiretroviral Therapy on Pulmonary Function

614

516

Randomized Trial of Antenatal Late Preterm Steroids (ALPS)*

2,134

Randomized Trial of Maternal Vitamin D Supplementation To Prevent Childhood Asthma*

2,510

2,466

Effects of HIV Antiretroviral Therapy on Pulmonary Function

614

516

Randomized Trial of Antenatal Late Preterm Steroids (ALPS)*

2,134

Vitamin D Supplementation in Pregnancy: Impact on Neonatal Immune Phenotype

323

Role of Beta-Catenin in Epithelial Repair in Acute Lung Injury

125

Mechanisms of Familial Pulmonary Fibrosis

2,330

Multicomponent Intervention To Decrease COPD-Related Hospitalizations

412

Subtotal, Lung Diseases

15,484

17,076

18,974

15,639

14,289

10,056

9,294

9,398

7,347

20,017

23,934

Blood Diseases and Resources

 

 

 

 

 

 

 

 

 

 

 

Stroke Prevention in Sickle Cell Anemia (STOP)*

293

Stroke Prevention in Sickle Cell Anemia (STOP 2)*

4,200

3,166

3,168

2,320

2,366

Induction of Stable Chimerism for Sickle Cell Anemia*

489

525

527

551

Sibling Donor Cord Blood Banking and Transplantation*

1,222

1,224

1,286

1,353

FOCUS*

1,639

1,796

2,923

2,446

1,974

Stroke With Transfusions Changing to Hydroxyurea (SWiTCH)*

3,345

3,932

3,531

3,828

3,216

1,778

Randomized Trial of Interventions To Improve Warfarin Adherence

801

787

771

Study of Low Molecular Weight Heparin as a Bridge Before or After Surgery or a Procedure (BRIDGE)* †

4,632

5,673

5,227

Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT)‡  

2,071

2,108

2,094

Transcranial Doppler With Transfusions Changing to Hydroxyurea (TWiTCH)

4,176

4,177

Impact of Blood Storage Duration on Measures: RECESS Ancillary Study

387

Subtotal, Blood Diseases and Resources

4,493

4,877

4,917

5,772

6,066

6,268

6,378

5,505

11,332

15,960

14,434

Total, NHLBI

$46,555

$44,949

$69,144

$71,574

$72,732

$73,005

$73,984

$59,994

$40,416

$63,099

$74,906

*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

 

Total Obligations
Prior to FY 2010

FY 2010
Obligations

Total Obligations
to Date

Heart and Vascular Diseases

 

 

 

AIM HIGH: Niacin Plus Statin To Prevent Vascular Events*

$ 16,710,039

$ 6,927,377

$ 23,637,416

Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)*

21,413,274

4,413,950

25,827,224

Catheter Ablation Versus Antiarrythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)*

2,940,676

3,044,967

5,985,643

Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)*

6,567,493

1,079,923

7,647,416

Collaborative Model To Improve BP Control and Minimize Racial Disparities

1,962,536

1,938,361

3,900,897

Effects of Niacin on Lp(a), Oxidized LDL, and Inflammation in the AIM-HIGH Trial

613,764

383,483

997,247

FREEDOM Trial: Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease

17,988,870

3,428,589

21,417,459

Interventions To Control Obesity in College

2,656,815

588,410

3,245,225

Late Sodium Blockade in High-Risk ICD Patients*

                   —

2,279,794

2,279,794

Multiscale Model of the Human Heart for Imaging Research

565,856

502,961

1,068,817

Occluded Artery Trial (OAT)

21,223,324

1,032,987

22,256,311

Planned Care for Obesity and Risk Reduction (Planned CORR)

1,554,163

768,874

2,323,037

Rule-Out Myocardial Infarction Using Computer Assisted Tomography (ROMICAT II)*

2,111,994

2,307,194

4,419,188

Surgical Treatment for Ischemic Heart Failure (STICH)*

37,243,638

1,233,343

38,476,981

Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA)*

3,648,449

2,285,274

5,933,723

Vest Prevention of Early Sudden Death Trial (VEST) and PREDiction of ICd Therapies Studies (PREDICTS)*

4,137,380

1,403,538

5,540,918

Vitamin D and Omega 3 Trial (VITAL)*

1,260,000

1,247,778

2,507,778

Women's Health Study (WHS)

19,584,523

926,561

20,511,084

Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction

1,517,476

745,442

2,262,918

Subtotal, Heart and Vascular Diseases

163,700,270

36,538,806

200,239,076

Lung Diseases

 

 

 

Childhood Asthma Management Program–Phase III (CAMP III)* **

5,188,779

2,065,318

7,254,097

Early Insulin Therapy and Development of ARDS

1,407,511

417,188

1,824,699

Effects of HIV Antiretroviral Therapy on Pulmonary Function

613,957

515,991

1,129,948

Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans

225,000

187,500

412,500

Infant Study of Inhaled Saline in Cystic Fibrosis (ISIS)*

1,469,184

775,690

2,244,874

Mechanisms of Familial Pulmonary Fibrosis

 

2,330,347

2,330,347

Multicomponent Intervention To Decrease COPD-Related Hospitalizations

 

411,777

411,777

Outpatient Treatment of Low-Risk Patients With Pulmonary Embolism

755,080

349,378

1,104,458

Physical Activity Self-Management in Patients With COPD

662,744

660,370

1,323,114

Randomized Controlled Study of Adenotonsillectomy for Childhood Sleep Apnea*

8,488,920

1,674,567

10,163,487

Randomized Trial of Antenatal Late Preterm Steroids (ALPS)*

                    —

2,133,947

2,133,947

Randomized Trial of Maternal Vitamin D Supplementation To Prevent Childhood Asthma*

2,510,267

2,465,649

4,975,916

Role of Beta-Catenin in Epithelial Repair in Acute Lung Injury

 

125,172

125,172

Scleroderma Lung Study II

4,577,300

2,251,504

6,828,804

Sedation Management in Pediatric Patients With Acute Respiratory Failure*

4,452,227

3,326,889

7,779,116

Study of Asthma and Nasal Steroids (STAN)*

724,724

724,812

1,449,536

Study of Soy Isoflavones in Asthma (SOYA)*

774,607

697,247

1,471,854

Translating COPD Guidelines Into Primary Care Practice

733,424

718,575

1,451,999

Trial of Late Surfactant To Prevent Bronchopulmonary Dysplasia (TOLSURF)*

1,986,898

1,778,953

3,765,851

Vitamin D Supplementation in Pregnancy: Impact on Neonatal Immune Phenotype

 

323,300

323,300

Subtotal, Lung Diseases

34,570,622

23,934,174

58,504,796

Blood Diseases and Resources

 

 

 

Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT)*

4,178,531

2,094,006

6,272,537

Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Study

 

386,523

386,523

Randomized Trial of Interventions To Improve Warfarin Adherence

1,587,429

770,987

2,358,416

Stroke With Transfusions Changing to Hydroxyurea (SWiTCH)*

17,852,750

1,778,230

19,630,980

Study of Low Molecular Weight Heparin as a Bridge Before or After Surgery or a Procedure (BRIDGE)*

10,305,131

5,226,772

15,531,903

Transcranial Doppler With Transfusions Changing to Hydroxyurea (TWiTCH)

4,175,979

4,177,447

8,353,426

Subtotal, Blood Diseases and Resources

26,207,260

14,433,965

40,641,225

TOTAL, NHLBI

$224,478,152

$74,906,945

$299,385,097

* 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)

  FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010

Heart and Vascular Diseases

 

 

 

 

 

 

 

 

 

 

 

Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT)

6,259

7,000

3,980

2,761

3,346

1,235

Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD)

3,487

596

425

70

Atrial Fibrillation Follow-Up: Investigation in Rhythm Management (AFFIRM)

1,239

2,401

802

Women's Angiographic Vitamin and Estrogen Trial (WAVE)

886

756

32

Women's Ischemia Syndrome  Evaluation (WISE)

1,424

10

50

Prevention of Events With Angiotensin Converting Enzyme Inhibitor Therapy (PEACE)

5,988

2,849

558

Magnesium in Coronaries (MAGIC)

1,243

238

Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE)

1,820

1,129

311

Action To Control Cardiovascular Risk in Diabetes (ACCORD)

6,590

1,750

18,521

33,779

26,126

19,484

16,343

15,461

403

Public Access Defibrillation (PAD) Community Trial

2,414

3,058

1,101

Trial of Aldosterone Antagonist Therapy in Adults With Preserved Ejection Fraction Congestive Heart Failure (TOPCAT)

837

5,162

5,480

2,218

7,912

4,408

898

Women's Health Initiative

57,700

59,200

59,010

63,222

57,483

37,826

12,124

14,873

22,609

30,615

2,409

Systolic Blood Pressure Intervention Trial (SPRINT)

3,057

29,374

Clarification of Optimal Anticoagulation Through Genetics (COAG)*

2,637

3,530

Subtotal, Heart and Vascular Diseases

89,050

73,021

71,334

85,164

95,445

69,114

17,915

36,575

49,501

57,071

34,319

Lung Diseases

 

 

 

 

 

 

 

 

 

 

 

Pediatric Pulmonary and Cardiac Complications of HIV Infection (P2C2)

315

113

Childhood Asthma Management Program (CAMP)

729

1,330

2,786

2,287

1,475

599

Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)

5,587

2,667

1,502

4,402

5,517

4,707

7,396

5,037

1,992

6,195

7,208

National Emphysema Treatment Trial (NETT)

4,047

6,989

7,910

1,630

1,648

357

285

Feasibility of Retinoid Treatment in Emphysema (FORTE)

7,711

2,429

725

507

185

Long-Term Oxygen Treatment Trial (LOTT)

6,208

10,042

202

4,335

Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS)

2,082

27,960

Subtotal, Lung Diseases

18,389

10,986

14,740

9,044

9,147

5,848

7,396

11,245

12,034

8,764

39,503

Blood Diseases and Resources

 

 

 

 

 

 

 

 

 

 

 

Clinical Course of Sickle Cell Disease

106

T-Cell Depletion in Unrelated Donor Marrow Transplantation

1,085

1,144

557

774

164

Viral Activation Transfusion Study (VATS)

339

Cord Blood Stem Cell Transplantation Study (COBLT)

5,122

1,846

2,166

588

707

822

Multicenter Study of Hydroxyurea (MSH) in Sickle Cell Anemia Adult Follow-Up

588

994

1,136

1,340

Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)

1,606

405

3,100

1,112

1,964

1,526

891

3,966

5,573

1,704

Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension

1,867

2,801

3,702

963

320

Subtotal, Blood Diseases and Resources

8,258

3,395

6,411

3,468

3,971

3,688

2,758

6,767

9,275

2,667

320

Total, NHLBI Clinical Trials Contracts

$115,697

$87,402

$92,485

$97,676

$108,563

$78,650

$28,069

$54,587

$70,810

$68,502

$74,142

* 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)

  FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010

Heart and Vascular Diseases

 

 

 

 

 

 

 

 

 

 

 

Bypass Angioplasty Revascularization
Investigation (BARI)

$ 1,634

$ 1,549

$ 1,456

$      —

$      —

$      —

$      —

$      —

$      —

$     —

$     —

Obesity Prevention in  Young American  Indians (PATHWAYS)

2,459

Girls Health Enrichment  Multisite Studies (GEMS)

2,365

2,877

2,713

Trial of Activity for  Adolescent Girls (TAAG)

5,274

4,831

5,919

5,828

6,350

5,103

905

Pediatric Heart Network

3,447

4,822

5,381

4,948

3,992

6,988

6,607

12,255

7,637

7,471

Clinical Research  Consortium To Improve Resuscitation Outcome

6,886

9,339

9,728

8,972

5,279

6,244

Dynamic Assessment of  Patient-Reported Chronic Disease Outcomes

1,010

Heart Failure Clinical Research Network

5,642

7,801

7,813

7,939

262

Pediatric HIV/AIDS Cohort Study (PHACS)—Data and Operations Center

1,000

500

490

500

Cardiovascular Cell Therapy Research Network

4,424

7,568

6,227

6,200

Community-Responsive Interventions To Reduce Cardiovascular Risk in American Indians and Alaska Natives

1,419

2,314

3,151

1,999

2,071

Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine

6,009

8,681

3,210

8,079

EDTA Chelation Therapy for Coronary Artery Disease

2,109

Practice-Based Opportunity for Weight Reduction (POWER) Trials*

3,729

2,329

Look AHEAD: Action for Health in Diabetes

4,000

Diabetes Prevention Program Outcomes Study—Phase II

1,100

Early Adult Reduction of Weight Through LifestYle Intervention (EARLY) Trials**

4,656

5,864

Childhood Obesity Prevention and Treatment Research (COPTR)

4,058

Effectiveness Research on Smoking Cessation in Hospitalized Patients

3,322

Other Clinical Trials

78,858

Subtotal, Heart and Vascular Diseases

11,732

12,704

14,910

11,209

19,194

18,434

28,249

40,341

48,893

43,106

129,858

Lung Diseases

 

 

 

 

 

 

 

 

 

 

 

Asthma Clinical Research Network (ACRN)

8,181

8,424

8,667

7,839

8,918

872

Childhood Asthma Research and Education (CARE) Network

5,002

5,314

6,005

5,610

5,292

5,704

5,735

5,916

4,887

COPD Clinical Research Network

6,843

6,848

8,438

7,664

6,836

3,400

3,150

3,150

Idiopathic Pulmonary Fibrosis Clinical Research Network

3,486

7,349

7,216

7,154

7,325

NICHD Cooperative Multicenter Neonatal Research Network

1,336

238

27

Asthma Network (AsthmaNet)

8,300

15,500

Novel Therapies for Lung Diseases—Phase II

7,594

Subtotal, Lung Diseases

5,002

5,314

6,005

20,634

20,564

26,295

29,923

29,124

16,340

18,775

26,244

Blood Diseases and Resources

 

 

 

 

 

 

 

 

 

 

 

Thalassemia (Cooley's Anemia) Clinical Research Network

2,192

2,219

2,269

2,320

2,375

2,730

2,682

2,618

2,600

658

Blood and Marrow  Transplant Clinical Research Network

5,360

5,899

5,950

5,972

6,460

6,845

6,709

6,952

6,351

2,507

Transfusion Medicine/ Hemostasis Clinical Research Network

6,053

6,241

6,093

6,221

6,521

6,407

6,374

6,541

6,590

Sickle Cell Disease Clinical Research Network

3,761

7,498

7,173

Subtotal, Blood Diseases and Resources

2,192

7,579

14,221

14,511

14,440

15,411

19,809

23,232

23,099

13,550

9,097

Total, NHLBI-Initiated  Clinical Trials, Cooperative Agreements

$18,926

$25,597

$35,136

$46,354

$54,198

$60,140

$77,981

$92,697

$88,332

$75,431

$165,199

Total, NHLBI-Initiated  Clinical Trials

$134,623

$112,999

$127,621

$144,030

$162,761

$138,790

$106,050

$147,284

$159,142

$143,933

$239,341

* 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

 

Total Obligations
Prior to FY 2010

Total FY 2010
Obligations

Total Obligations
to Date

Heart and Vascular Diseases

     

Action To Control Cardiovascular Risk in Diabetes (ACCORD)

$   142,184,481

$     403,065

$   142,587,546

Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT)

83,170,059

1,235,371

84,405,430

Clarification of Optimal Anticoagulation Through Genetics (COAG)*

6,167,062

                       —

6,167,062

Systolic Blood Pressure Intervention Trial (SPRINT)

7,508,288

29,374,119

36,882,407

Trial of Aldosterone Antagonists Therapy in Adults With Preserved Ejection Fraction Congestive Heart Failure (TOPCAT)

26,016,365

897,950

26,914,315

Women’s Health Initiative (WHI)

790,662,086

2,408,632

793,070,718

Subtotal, Heart and Vascular Diseases 

1,055,708,341

34,319,137

1,090,027,478

Lung Diseases

     

Acute Respiratory Distress Syndrome Clinical Network (ARDSNET)

71,534,973

7,207,532

78,742,505

Long-Term Oxygen Treatment Trial (LOTT)

16,452,447

4,334,914

20,787,361

Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS)

2,081,851

27,960,468

30,042,319

Subtotal, Lung Diseases

90,069,271

39,502,914

129,572,185

Blood Diseases and Resources

     

Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)

21,847,533

                       —

21,847,533

Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension

9,333,094

320,083

9,653,177

Subtotal, Blood Diseases and Resources

31,180,627

320,083

31,500,710

Total, NHLBI-Initiated Clinical Trials, Contracts

$1,176,958,239

$74,142,134

$1,251,100,373

* 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

 

Total Obligations
Prior to FY 2010

Total FY 2010
Obligations

Total Obligations
to Date

Heart and Vascular Diseases

     

Cardiovascular Cell Therapy Research Network

$     18,219,368

$    6,199,959

$     24,419,327

Childhood Obesity Prevention and Treatment Research (COPTR)

                        —

4,058,435

4,058,435

Clinical Research Consortium To Improve Resuscitation Outcome

40,203,762

6,243,690

46,447,452

Community-Responsive Interventions To Reduce Cardiovascular Risk in American Indians and Alaska Natives

8,882,655

2,070,651

10,953,306

Diabetes Prevention Program Outcomes Study—Phase II

1,100,000

1,100,000

2,200,000

Early Adult Reduction of Weight Through LifestYle Intervention (EARLY) Trials*

4,656,109

5,863,594

10,519,703

Effectiveness Research on Smoking Cessation in Hospitalized Patients

                        —

3,321,649

3,321,649

Heart Failure Clinical Research Network

29,194,950

262,170

29,457,120

Look AHEAD:  Action for Health in Diabetes

4,000,000

4,000,000

8,000,000

Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine

17,900,101

8,078,705

25,978,806

Pediatric Heart Network

55,877,857

7,471,016

63,348,873

Pediatric HIV/AIDS Cohort Study:  Data and Operations Center (PHACS)

2,490,000

                        —

2,490,000

Practice-Based Opportunity for Weight Reduction (POWER) Trials**

13,666,191

2,329,121

15,995,312

Other Clinical Trials

 

78,858,002

78,858,802

Subtotal, Heart and Vascular Diseases

196,190,993

129,857,792

326,048,785

Lung Diseases

     

Asthma Network (AsthmaNet)

8,300,000

15,500,000

23,800,000

COPD Clinical Research Network

43,180,386

3,150,000

46,330,386

Novel Therapies for Lung Diseases—Phase II

                        —

7,593,739

7,593,739

Subtotal, Lung Diseases

51,480,386

26,243,739

70,130,386

Blood Diseases and Resources

     

Blood and Marrow Transplant Clinical Research Network

56,563,600

2,507,421

59,071,021

Transfusion Medicine/Hemostasis Clinical Research Network

50,450,201

6,589,859

57,040,060

Subtotal, Blood Diseases and Resources

107,013,801

9,097,280

116,111,081

Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements

$354,685,180

$165,198,811

$512,290,252

Total, NHLBI-Initiated Clinical Trials

$1,531,643,419

$239,340,945

$1,763,390,625

* 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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