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 1999–2009

Research Grants and Cooperative Agreements (Dollars in Thousands)

 

FY 1999

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

FY 2008

FY 2009

Heart and Vascular Diseases

 

 

 

 

 

 

 

 

 

 

 

Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest

$ 584

$ 392

$ 75

$ —

$ —

$ —

$ —

$ —

$ —

$ —

$ —

Women's Health Study (WHS)

1,530

1,594

889

868

875

919

Cardiovascular Risk Factors and the Menopause

186

Women's Antioxidant and Cardiovascular Study (WACS)

540

556

572

598

592

599

670

Stress Reduction and Atherosclerotic CVD in Blacks

326

339

360

376

394

Estrogen Replacement and Atherosclerosis (ERA) Trial*

1,017

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)*

1,131

32

Mode Selection Trial in Sinus Node Dysfunction (MOST)*

2,879

1,136

154

Postmenopausal Hormone Therapy in Unstable Angina

276

Estrogen and Graft Atherosclerosis Research Trial (EAGER)*

361

371

REMATCH Trial*

1,333

825

750

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

3,646

1,247

151

387

376

395

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

1,709

1,698

1,798

1,412

1,930

CVD Risk and Health in Post-Menopausal Phytoestrogen Users

574

244

304

152

Treatment of Hypertension With Two Exercise Intensities

473

481

420

Prevention of Recurrent Venous Thromboembolism (PREVENT)

894

521

543

1,272

PREMIER: Lifestyle Interventions for Blood Pressure Control*

3,425

3,595

2,925

1,505

Azithromycin and Coronary Events Study (ACES)*

2,663

2,182

720

1,254

1,137

Antiarrhythmic Effects of N-3 Fatty Acids

514

542

529

647

Fatty Acid Antiarrhythmia Trial (FAAT)

519

605

Occluded Artery Trial (OAT)*

4,892

5,079

2,604

1,724

1,963

963

1,452

1,277

1,270

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

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

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

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

Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)*

1,368

1,478

1,898

1,822

Intervention To Control Obesity in College

677

633

670

686

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

Planned Care for Obesity and Risk Reduction (Planned CORR)

784

770

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

302

312

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

776

742

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

2,112

Collaborative Model To Improve BP Control and Minimize Racial Disparities

1,963

Multi-Scale Model of the Human Heart for Imaging Research

566

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

2,941

Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA)*

3,648

Subtotal, Heart and Vascular Diseases

29,111

26,578

22,996

45,253

50,163

52,377

56,681

58,312

45,091

21,737

25,862

Lung Diseases

 

 

 

 

 

 

 

 

 

 

 

Lung Health Study III* **

1,986

1,616

1,672

927

Asthma Clinical Research Network (ACRN)* **

5,399

5,686

5,705

5,863

Fetal Tracheal Occlusion for Severe Diaphragmatic Hernia*

419

429

181

Scleroderma Lung Study*

1,040

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

Early Insulin Therapy and Development of ARDS

489

454

464

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

2,077

1,966

1,146

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

732

737

Scleroderma Lung Study II

2,281

2,297

Sedation Management in Pediatric Patients With Acute Respiratory Failure*

568

3,885

Study of Asthma and Nasal Steroids (STAN)*

725

Outpatient Treatment of Low-Risk Patients With Pulmonary Embolism

755

Translating COPD Guidelines Into Primary Care Practice

733

Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans

225

Physical Activity Self-Management in Patients With COPD

663

Study of Soy Isoflavones in Asthma (SOYA)*

775

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

1,987

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

2,510

Effects of HIV Antiretroviral Therapy on Pulmonary Function

614

Subtotal, Lung Diseases

8,844

15,484

17,076

18,974

15,639

14,289

10,056

9,294

9,398

7,347

20,017

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

Randomized Trial of Interventions To Improve Warfarin Adherence

801

787

Bridging Anticoagulation on Patients Requiring Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial*

4,632

5,673

Pharmacomechanical Catheter-Directed Thrombolysis for Acute DVT–ATTRACT Trial

2,071

2,108

Transcranial Doppler With Transfusions Changing to Hydroxyurea

4,176

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

Total, NHLBI

$37,955

$46,555

$44,949

$69,144

$71,574

$72,732

$73,005

$73,984

$59,994

$40,416

$61,839

*Paid by U01/U10.
**Previously an Institute-Initiated Clinical Trial.

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NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2009:  Summary by Program

 

Total Obligations
Prior to FY 2009

FY 2009
Obligations

Total Obligations
to Date

Heart and Vascular Diseases

 

 

 

AIM HIGH: Niacin Plus Statin To Prevent Vascular Events*

$14,385,611

$2,324,428

$16,710,039

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

57,767,642

1,129,551

58,897,193

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

2,940,676

2,940,676

Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)*

4,745,409

1,822,084

6,567,493

Collaborative Model To Improve BP Control and Minimize Racial Disparities

1,962,536

1,962,536

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

301,776

311,988

613,764

Efficacy of Smoking Quit Line in the Military

1,458,373

731,359

2,189,732

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

16,330,637

1,658,233

17,988,870

Interventions To Control Obesity in College

1,970,554

686,261

2,656,815

Multi-Scale Model of the Human Heart for Imaging Research

565,856

565,856

Occluded Artery Trial (OAT)

19,953,495

1,269,829

21,223,324

Planned CORR: Planned Care for Obesity and Risk Reduction

784,317

769,846

1,554,163

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

2,111,994

2,111,994

Surgical Treatment for Ischemic Heart Failure (STICH)*

36,516,990

726,648

37,243,638

Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA)*

3,648,449

3,648,449

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

2,746,077

1,391,303

4,137,380

Weight Loss Maintenance (WLM)*

17,463,982

149,857

17,613,839

Women's Health Study (WHS)

18,665,689

918,834

19,584,523

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

775,836

741,640

1,517,476

Subtotal, Heart and Vascular Diseases

193,866,388

25,861,372

219,727,760

Lung Diseases

 

 

 

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

4,043,232

1,145,547

5,188,779

Early Insulin Therapy and Development of ARDS

943,216

464,295

1,407,511

Effects of HIV Antiretroviral Therapy on Pulmonary Function

613,957

613,957

Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans

225,000

225,000

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

732,476

736,708

1,469,184

Outpatient Treatment of Low-Risk Patients With Pulmonary Embolism

755,080

755,080

Physical Activity Self-Management in Patients With COPD

662,744

662,744

Randomized Controlled Study of Adenotonsillectomy for Childhood Sleep Apnea*

5,988,040

2,500,880

8,488,920

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

2,510,267

2,510,267

Scleroderma Lung Study II

2,280,616

2,296,684

4,577,300

Sedation Management in Pediatric Patients With Acute Respiratory Failure*

567,715

3,884,512

4,452,227

Study of Soy Isoflavones in Asthma (SOYA)*

774,607

774,607

Study of Asthma and Nasal Steroids (STAN)*

724,724

724,724

Translating COPD Guidelines Into Primary Care Practice

733,424

733,424

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

1,986,898

1,986,898

Subtotal, Lung Diseases

14,555,295

20,015,327

34,570,622

Blood Diseases and Resources

 

 

 

Bridging Anticoagulation on Patients Requiring Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial

4,632,060

5,673,071

10,305,131

Pharmacomechanical Catheter-Directed Thrombolysis for Acute DVT–ATTRACT Trial*

2,070,898

2,107,633

4,178,531

Randomized Trial of Interventions To Improve Warfarin Adherence

800,516

786,913

1,587,429

Stroke With Transfusions Changing to Hydroxyurea (SWITCH)*

14,636,993

3,215,757

17,852,750

Transcranial Doppler With Transfusions Changing to Hydroxyurea

4,175,979

4,175,979

Subtotal, Blood Diseases and Resources

22,140,467

15,959,353

38,099,820

TOTAL, NHLBI

$230,562,150

$61,836,052

$292,398,202

* Paid by U01/U10.

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Institute-Initiated Clinical Trials:  Fiscal Years 1999–2009

Contracts

Dollars (Thousands)

 

FY 1999

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

FY 2008

FY 2009

Heart and Vascular Diseases

 

 

 

 

 

 

 

 

 

 

 

Antiarrhythmic Versus Implantable Defibrillator (AVID)

$ 548

$ —

$ —

$ —

$ —

$ —

$ —

$ —

$ —

$ —

$ —

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

6,259

7,000

3,980

2,761

3,346

Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD)

3,303

3,487

596

425

70

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

3,785

1,239

2,401

802

Women's Angiographic Vitamin and Estrogen Trial (WAVE)

3,878

886

756

32

Women's Ischemia Syndrome Evaluation (WISE)

856

1,424

10

50

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

2,850

5,988

2,849

558

Magnesium in Coronaries (MAGIC)

2,009

1,243

238

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

1,750

1,820

1,129

311

Action To Control Cardiovascular Risk in Diabetes (ACCORD)

4,130

6,590

1,750

18,521

33,779

26,126

19,484

16,343

15,461

Public Access Defibrillation (PAD) Community Trial

2,923

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

Women's Health Initiative

59,100

57,700

59,200

59,010

63,222

57,483

37,826

12,124

14,873

22,609

30,615

Systolic Blood Pressure Intervention Trial (SPRINT)

7,508

Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy

2,637

3,530

Subtotal, Heart and Vascular Diseases

85,132

89,050

73,021

71,334

85,164

95,445

69,114

17,915

36,575

49,501

61,522

Lung Diseases

 

 

 

 

 

 

 

 

 

 

 

Pediatric Pulmonary and Cardiac Complications of HIV Infection (P2C2)

315

113

Childhood Asthma Management Program (CAMP)

6,551

729

1,330

2,786

2,287

1,475

599

Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)

6,837

5,587

2,667

1,502

4,402

5,517

4,707

7,396

5,037

1,992

6,195

National Emphysema Treatment Trial (NETT)

7,545

4,047

6,989

7,910

1,630

1,648

357

285

Feasibility of Retinoid Treatment in Emphysema (FORTE)

884

7,711

2,429

725

507

185

Long-Term Oxygen Treatment Trial (LOTT)

6,208

10,042

202

Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS)

2,082

Subtotal, Lung Diseases

21,817

18,389

10,986

14,740

9,044

9,147

5,848

7,396

11,245

12,034

8,764

Blood Diseases and Resources

 

 

 

 

 

 

 

 

 

 

 

Clinical Course of Sickle Cell Disease

350

106

T-Cell Depletion in Unrelated Donor Marrow Transplantation

690

1,085

1,144

557

774

164

Viral Activation Transfusion Study (VATS)

339

Cord Blood Stem Cell Transplantation Study (COBLT)

1,456

5,122

1,846

2,166

588

707

822

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

469

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

Subtotal, Blood Diseases and Resources

2,965

8,258

3,395

6,411

3,468

3,971

3,688

2,758

6,767

9,275

2,667

Total, NHLBI Clinical Trials Contracts

$109,914

$115,697

$87,402

$92,485

$97,676

$108,563

$78,650

$28,069

$54,587

$70,810

$72,953

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Cooperative Agreements

Dollars (Thousands)

 

FY 1999

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

FY 2008

FY 2009

Heart and Vascular Diseases

 

 

 

 

 

 

 

 

 

 

 

Bypass Angioplasty Revascularization Investigation (BARI)

$ 1,609

$ 1,634

$ 1,549

$ 1,456

$ —

$ —

$ —

$ —

$ —

$ —

$ —

Child and Adolescent Trial for Cardiovascular Health (CATCH)

210

Obesity Prevention in Young American Indians (PATHWAYS)

4,196

2,459

Girls Health Enrichment Multisite Studies (GEMS)

2,282

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

Clinical Research Consortium To Improve Resuscitation Outcome

6,886

9,339

9,728

8,972

5,279

Dynamic Assessment of Patient-Reported Chronic Disease Outcomes

1,010

Clinical Trials in Organ Transplantation (CTOT)

1,900

1,855

1,801

1,635

Heart Failure Clinical Research Network

5,642

7,801

7,813

7,939

Weight Loss in Obese Adults With Cardiovascular Risk Factors

2,567

3,714

3,656

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

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

1,419

2,314

3,151

1,999

Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine

6,009

8,681

3,210

EDTA Chelation Therapy for Coronary Artery Disease

2,109

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

3,729

Look AHEAD: Action for Health in Diabetes

4,000

Targeted Approaches to Weight Control for Young Adults

4,656

Diabetes Prevention Program Outcomes Study—Phase II

1,100

Subtotal, Heart and Vascular Diseases

8,297

11,732

12,704

14,910

11,209

19,194

20,334

30,104

42,142

50,528

43,106

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

4,175

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

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

Subtotal, Lung Diseases

4,175

5,002

5,314

6,005

20,634

20,564

26,295

29,923

29,124

16,340

18,775

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

Transfusion Medicine/ Hemostasis Clinical Research Network

6,053

6,241

6,093

6,221

6,521

6,407

6,374

6,541

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

Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements

$12,472

$18,926

$25,597

$35,136

$46,354

$54,198

$62,040

$79,836

$94,498

$89,967

$75,431

Total, NHLBI-Initiated Clinical Trials

$122,386

$134,623

$112,999

$127,621

$144,030

$162,761

$140,690

$107,905

$149,085

$158,140

$148,384

* Formerly known as Weight-Loss in Obese Adults With Cardiovascular Risk Factors.
**   Investigator-Initiated from 1998 to 2002.

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Institute-Initiated Clinical Trials, Fiscal Year 2009:  Summary by Program

Contracts

 

Total Obligations
Prior to FY 2009

Total FY 2009
Obligations

Total Obligations
to Date

Heart and Vascular Diseases

     

Action To Control Cardiovascular Risk in Diabetes (ACCORD)

$ 126,723,481

$15,461,000

$ 142,184,481

Systolic Blood Pressure Intervention Trial (SPRINT)

7,508,288

7,508,288

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

21,608,801

4,407,564

26,016,365

Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy

2,637,062

3,530,000

6,167,062

Women's Health Initiative

760,047,045

30,615,041

790,662,086

Subtotal, Heart and Vascular Diseases

911,016,389

61,521,893

972,538,282

Lung Diseases

 

 

 

Acute Respiratory Distress Syndrome Clinical Network (ARDSNET)

65,339,896

6,195,077

71,534,973

Long-Term Oxygen Treatment Trial (LOTT)

16,250,145

202,302

16,452,447

National Emphysema Treatment Trial (NETT)

36,203,000

285,156

36,488,156

Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS)

2,081,851

2,081,851

Subtotal, Lung Diseases

117,793,041

8,764,386

126,557,427

Blood Diseases and Resources

 

 

 

Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)

20,143,615

1,703,918

21,847,533

Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension

8,370,142

962,952

9,333,094

Subtotal, Blood Diseases and Resources

28,513,757

2,666,870

31,180,627

Total, NHLBI-Initiated Clinical Trials, Contracts

$1,057,323,187

$72,953,149

$1,130,276,336

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 2009

Total FY 2009
Obligations

Total Obligations
to Date

Heart and Vascular Diseases

     

Cardiovascular Cell Therapy Research Network

$ 11,992,445

$ 6,226,923

$ 18,219,368

Clinical Research Consortium To Improve Resuscitation Outcomes

40,203,762

40,203,762

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

6,883,288

1,999,367

8,882,655

Diabetes Prevention Program Outcomes Study—Phase II

1,100,000

1,100,000

EDTA Chelation Therapy for Coronary Artery Disease

2,109,044

2,109,044

Heart Failure Clinical Research Network

21,256,277

7,938,673

29,194,950

Look AHEAD: Action for Health in Diabetes

4,000,000

4,000,000

Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine

14,689,861

3,210,240

17,900,101

Pediatric Heart Network

48,440,735

7,637,122

56,077,857

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

1,990,000

500,000

2,490,000

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

9,937,264

3,728,927

13,666,191

Targeted Approaches to Weight Control for Young Adults

4,656,109

4,656,109

Subtotal, Heart and Vascular Diseases

155,393,632

43,106,405

198,500,037

Lung Diseases

 

 

 

Asthma Network (AsthmaNet)

8,300,000

8,300,000

COPD Clinical Research Network

40,030,386

3,150,000

43,180,386

Idiopathic Pulmonary Fibrosis Clinical Research Network

25,205,892

7,324,944

32,530,836

Subtotal, Lung Diseases

65,236,278

18,774,944

84,011,222

Blood Diseases and Resources

 

 

 

Blood and Marrow Transplant Clinical Research Network

50,147,120

6,350,697

56,497,817

Thalassemia (Cooley's Anemia) Clinical Research Network

22,006,021

657,580

22,663,601

Transfusion Medicine/Hemostasis Clinical Research Network

43,909,114

6,541,087

50,450,201

Subtotal, Blood Diseases and Resources

116,062,255

13,549,364

129,611,619

Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements

$336,692,165

$75,430,713

$412,122,878

Total, NHLBI-Initiated Clinical Trials

$1,412,987,091

$148,383,862

$1,565,778,517

* 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 clinical trial is to evaluate the effects of three diabetic treatment strategies (intensive glycemic control, blood pressure control, and fibrate treatment to raise HDL-cholesterol and lower triglycerides) to prevent major cardiovascular events in adults with type 2 diabetes mellitus. The primary outcome measure is 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 NHLBI announced that participants in the intensive glycemia treatment will be transitioned to the ACCORD standard treatment approach due to higher mortality in the intensive treatment group. The blood pressure and lipid trials are continuing as designed.

Obligations

Funding History:
Fiscal Year 2009—$15,461,000
Fiscal Years 1999–2008—$126,723,481
Total Funding to Date—$142,184,481

Current Active Organizations and Contract Numbers

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

Cardiovascular Cell Therapy Research Network, Initiated in Fiscal Year 2007

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

Obligations

Funding History:
Fiscal Year 2009—$6,226,923
Fiscal Years 2007–2008—$11,992,445
Total Funding to Date—$18,219,368

Current Active Organizations and Grant Numbers

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

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

The purpose of this study is to establish a resuscitation research consortium to conduct research in cardiopulmonary arrest and traumatic injury leading to arrest. The consortium will facilitate the rapid translation of promising scientific and clinical advances to improve resuscitation outcomes.

Obligations

Funding History:
Fiscal Year 2009—$0
Fiscal Years 2004–2008—$40,203,762
Total Funding to Date—$40,203,762

Current Active Organizations and Grant Numbers

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

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

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

Obligations

Funding History:
Fiscal Year 2009—$1,999,367
Fiscal Years 2006–2008—$6,883,288
Total Funding to Date—$8,882,655

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 (metforminon 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 2009—$1,100,000
Total Funding to Date—$1,100,000

Current Active Organizations and Grant Numbers

  1. University of California, San Diego
    La Jolla, California —DK-048339
  2. Albert Einstein College of Medicine of
    Yeshiva University
    Bronx, New York —DK-048349
  3. University of Colorado
    Aurora, Colorado —DK-048375
  4. Louisiana State University
    Pennington Biomedical Research Center
    Baton Rouge, Louisiana —DK-048377
  5. Northwestern University
    Chicago, Illinois —DK-048380
  6. University of Chicago
    Chicago, Illinois —DK-048381
  7. MEDSTAR Research Institute
    Hyattsville, Maryland —DK-048387
  8. Massachusetts General Hospital
    Boston, Massachusetts —DK-048397
  9. Washington University
    St. Louis, Missouri —DK-048400
  10. St. Luke's Roosevelt Institute
    for Health Sciences
    New York, New York —DK-048404
  11. Indiana University-Purdue
    University at Indianapolis
    Indianapolis, Indiana —DK-048406
  12. University of New Mexico
    Albuquerque, New Mexico —DK-048407
  13. University of Tennessee Health
    Science Center
    Memphis, Tennessee —DK-048411
  14. University of Pittsburgh
    Pittsburgh, Pennsylvania —DK-048412
  15. Seattle Institute for Biomedical
    and Clinical Research
    Seattle, Washington —DK-048413
  16. University of Miami School of Medicine
    Coral Gables, Florida —DK-048434
  17. Joslin Diabetes Center
    Boston, Massachusetts —DK-048437
  18. University of California, Los Angeles
    Los Angeles, California —DK-048443
  19. Thomas Jefferson University
    Philadelphia, Pennsylvania —DK-048468
  20. George Washington University
    Washington, DC —DK-048489
  21. University of Texas
    Health Science Center
    San Antonio, Texas —DK-048514

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

The purpose of this multisite, 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 2009—$2,109,044
Total Funding to Date—$2,109,044

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 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 2009—$7,938,673
Fiscal Years 2006–2008—$21,256,277
Total Funding to Date—$29,194,950

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 2009—$4,000,000
Total Funding to Date—$4,000,000

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

Obligations

Funding History:
Fiscal Year 2009—$3,210,240
Fiscal Years 2007–2008—$14,689,861
Total Funding to Date—$17,900,101

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 2009—$7,637,122
Fiscal Years 2001–2008—$48,440,735
Total Funding to Date—$56,077,857
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 understand more fully the effect of HIV on sexual maturation, pubertal development, and socialization of perinatally HIV-infected preadolescents and adolescents, and to acquire more definitive information regarding long-term safety of antiretroviral agents when used during pregnancy and in newborns.

Obligations

Funding History:
Fiscal Year 2009—$500,000
Fiscal Years 2006–2008—$1,990,000
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 study is to conduct randomized clinical trials in routine clinical practice settings to test the effectiveness of weight loss interventions in obese patients who have one or more additional cardiovascular risk factors. An important secondary focus of these effectiveness clinical trials is to incorporate the weight loss strategies with approaches to improve application of evidence-based guidelines to reduce the other cardiovascular risk factors commonly present in obese patients, such as elevated lipids, hypertension, metabolic syndrome, diabetes, or cigarette smoking. All of the participants will be from minority populations.

Obligations

Funding History:
Fiscal Year 2009—$3,728,927
Fiscal Years 2006–2008—$9,937,264
Total Funding to Date—$13,666,191

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

Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy, Initiated in Fiscal Year 2008

The purpose of this 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”).

Obligations

Funding History:
Fiscal Year 2009—$3,530,000
Fiscal Year 2008—$2,637,062
Total Funding to Date—$6,167,062

Current Active Organization and Contract Number

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

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

The purpose of this study is to establish a clinical network to test the effects of intensive lowering of systolic blood pressure (SBP) on preventing CVD. Approximately 7,500 participants will be randomized into one of two groups—either the lower SBP goal of less than 120 mmHg or the standard SBP goal of less than 140 mmHg. The primary composite endpoints will be CVD mortality and non-fatal MI, stroke, and heart failure.

Obligations

Funding History:
Fiscal Year 2009—$7,508,288
Total Funding to Date—$7,508,288

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

Targeted Approaches to Weight Control for Young Adults, Initiated in Fiscal Year 2009

The purpose of this study is to conduct two-phase clinical research studies to develop and evaluate innovative behavioral and environmental approaches for weight control in young adults. The first phase will consist of research to refine the proposed intervention, recruitment, retention, and adherence strategies. The second phase will consist of a randomized controlled trial to test the efficacy of the intervention. The study will target ethnically and socioeconomically diverse adults, ages 18–35 years, who are at high risk of gaining weight (e.g., having an overweight parent, postpartum women, becoming a parent).

Obligations

Funding History:
Fiscal Year 2009—$4,656,109
Total Funding to Date—$4,656,109

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

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

The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy to reduce mortality in patients who have heart failure with preserved systolic function.

Obligations

Funding History:
Fiscal Year 2009—$4,407,564
Fiscal Years 2004–2008—$21,608,801
Total Funding to Date—$26,016,365

Current Active Organization and Contract Number

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

Women's Health Initiative, Initiated in Fiscal Year 1992

The purpose of the WHI is to study cardiovascular disease, cancer, and osteoporosis in postmenopausal women. The program consists of three major components: 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 2009—$30,615,041
Fiscal Years 1992–2008**—$760,047,045
Total Funding to Date—$790,662,086

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. The 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 2009—$6,195,077
Fiscal Years 1994–2008—$65,339,896
Total Funding to Date—$71,534,973

Current Active Organizations and Contract Numbers

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

Asthma 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 2009—$8,300,000
Total Funding to Date—$8,300,000

Current Active Organizations and Grant Numbers

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

COPD Clinical Research Network, Initiated in Fiscal Year 2003

The purpose of this network is to investigate disease management approaches 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 2009—$3,150,000
Fiscal Years 2003–2008—$40,030,386
Total Funding to Date—$43,180,386

Current Active Organizations and Grant Numbers

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

Idiopathic Pulmonary Fibrosis Clinical Research Network, Initiated in Fiscal Year 2005

The purpose of this network is to establish six to seven clinical centers to design and perform multiple therapeutic trials for treatment of patients with newly diagnosed idiopathic pulmonary fibrosis and a Data Coordinating Center for the network.

Obligations

Funding History:
Fiscal Year 2009—$7,324,944
Fiscal Years 2005–2008—$25,205,892
Total Funding to Date—$32,530,836

Current Active Organizations and Grant Numbers

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

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

The purpose of this program is to determine the effectiveness and safety of long-term, home-administered oxygen therapy in patients with COPD. Approximately 3,200 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 2009—$202,302
Fiscal Years 2007–2008—$16,250,145
Total Funding to Date—$16,452,447

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. The Ohio State University
    Columbus, Ohio —HR-76189
  8. Temple University
    Philadelphia, Pennsylvania —HR-76190
  9. University of Alabama at Birmingham
    Birmingham, Alabama —HR-76191
  10. University of Michigan
    Ann Arbor, Michigan —HR-76192
  11. University of Pittsburgh
    Pittsburgh, Pennsylvania —HR-76193
  12. University of Utah
    Salt Lake City, Utah —HR-76194
  13. University of Washington
    Seattle, Washington —HR-76195
  14. Washington University
    St. Louis, Missouri —HR-76196
  15. Johns Hopkins University
    Baltimore, Maryland —HR-76197

National Emphysema Treatment Trial (NETT), Initiated in Fiscal Year 1997

The NETT was designed to determine the role, safety, and effectiveness of lung volume reduction surgery in the treatment of severe emphysema. Investigators continue to analyze data from the original NETT Master Data set and to publish their findings.

Obligations

Funding History:
Fiscal Year 2009—$285,156
Fiscal Years 1997–2008—$36,203,000
Total Funding to Date—$36,488,156

Current Active Organization and Contract Number

  1. Johns Hopkins University
    Baltimore, Maryland —HR-76119

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

The purpose of this study is to define pathogenetically homogeneous subgroups of COPD subjects on the basis of biomarkers, genotypes, and computed tomography images and to 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 2009—$2,081,851
Total Funding to Date—$2,081,851

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
    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 promote the efficient comparison of novel treatment methods and management strategies of potential benefit for children and adults undergoing blood or marrow transplantation.

Obligations

Funding History:
Fiscal Year 2009—$6,350,697
Fiscal Years 2001–2008—$50,147,120
Total Funding to Date—$56,497,817

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

Obligations

Funding History:
Fiscal Year 2009—$1,703,918
Fiscal Years 2000–2008—$20,143,615
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. 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 18 weeks of therapy with sildenafil, a nitric oxide potentiator, in adult patients with SCD and pulmonary hypertension; exercise endurance and pulmonary artery pressure will be measured. Pulmonary hypertension occurs in up to 30 percent of SCD cases and is strongly associated with mortality in adults with SCD.

Obligations

Funding History:
Fiscal Year 2009—$962,952
Fiscal Years 2006–2008—$8,370,142
Total Funding to Date—$9,333,094

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

Thalassemia (Cooley's Anemia) Clinical Research Network, Initiated Fiscal Year 2000

The purpose of this network is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers.

Obligations

Funding History:
Fiscal Year 2009—$657,580
Fiscal Years 2000–2008—$22,006,021
Total Funding to Date—$22,663,601

Current Active Organizations and Grant Numbers

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

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

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

Obligations

Funding History:
Fiscal Year 2009—$6,541,087
Fiscal Years 2002–2008—$43,909,114
Total Funding to Date—$50,450,201

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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