« Factbook Table of Contents

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 1997–2007

Research Grants and Cooperative Agreements (Dollars in Thousands)

 

FY 1997

FY 1998

FY 1999

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

Heart and Vascular Diseases

                     

Program on Surgical Control of Hyperlipidemias (POSCH)

$   294

$     —

$     —

$     —

$  —

$  —

$  —

$  —

$  —

$  —

$  —

Infant Heart Surgery:  Central Nervous System Sequelae of Circulatory Arrest

685

582

584

392

75

Women’s Health Study (WHS)

1,473

1,536

1,530

1,594

889

735

Cardiovascular Risk Factors and the Menopause

494

528

186

CABG Patch Trial*

1,171

Women’s Antioxidant and Cardiovascular Study (WACS)

501

525

540

556

572

598

592

599

670

Oral Calcium in Pregnant Women With Hypertension

332

Stress Reduction and Atherosclerotic CVD in Blacks

407

40

326

339

360

376

394

Enalapril After Anthracycline Cardiotoxicity

724

789

Stress and Anger Management for Blacks With Hypertension

250

Estrogen Replacement and Atherosclerosis (ERA) Trial*

965

1,668

1,017

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

826

874

440

362

298

291

296

HDL-Atherosclerosis Treatment Study

445

340

326

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

1,196

1,269

1,131

32

Mode Selection Trial in Sinus Node Dysfunction (MOST)*

2,096

1,700

2,879

1,136

154

Antioxidants and Prevention of Early Atherosclerosis*

603

Postmenopausal Hormone Therapy in Unstable Angina

264

271

276

Estrogen and Graft Atherosclerosis Research Trial (EAGER)*

488

305

361

371

Soy Estrogen Alternative Study (SEA)

217

221

REMATCH Trial*

1,258

1,798

1,333

825

750

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

2,233

3,693

3,646

1,247

151

387

376

395

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

1,571

1,667

1,709

1,698

1,798

1,412

1,930

CVD Risk and Health in Post-Menopausal Phytoestrogen Users

631

662

574

244

304

152

Treatment of Hypertension With Two Exercise Intensities

359

474

473

481

420

Prevention of Recurrent Venous Thromboembolism (PREVENT)

1,242

894

521

543

1,272

PREMIER:  Lifestyle Interventions for Blood Pressure Control*

2,234

3,425

3,595

2,925

1,505

Azithromycin and Coronary Events Study (ACES)*

847

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

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

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

861

740

304

Reduction of Triglycerides in Women on HRT

708

746

555

544

721

625

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

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

Surgical Treatment for Ischemic Heart Failure (STICH)*

5,709

4,495

1,613

6,082

5,583

9,396

Girls Health Enrichment Multisite Studies (GEMS)*

2,461

2,400

2,370

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

Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)*

4,343

5,610

4,884

3,307

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

3,663

4,669

5,180

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

Claudication:  Exercise Versus Endoluminal Revascularization (CLEVER)*

1,368

1,478

1,898

Intervention To Control Obesity in College

677

633

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

1,300

4,555

Efficacy of Smoking Quit Line in the Military

739

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

1,390

Subtotal, Heart and Vascular Diseases

19,483

23,265

29,111

26,578

22,996

45,253

50,163

52,377

56,681

58,312

44,958

Lung Diseases

                     

Inhaled Beclomethasone To Prevent Chronic Lung Disease*

436

Lung Health Study II* **

3,508

980

Lung Health Study III* **

1,997

1,986

1,616

1,672

927

Asthma Clinical Research Network (ACRN)* **

4,934

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

Clinical Trial of 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

Adenotonsillectomy for Childhood Sleep Apnea

2,255

2,388

Early Insulin Therapy and Development of ARDS

489

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

2,077

Subtotal, Lung Diseases

3,944

7,911

8,844

15,484

17,076

18,974

15,639

14,289

10,056

9,294

9,398

Blood Diseases and Resources

                     

Stroke Prevention in Sickle Cell Anemia (STOP)*

2,584

2,036

293

Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG)

270

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

Subtotal, Blood Diseases and Resources

2,854

2,036

4,493

4,877

4,917

5,772

6,066

6,268

6,378

5,505

Total, NHLBI

$26,281

$33,212

$37,955

$46,555

$44,949

$69,144

$71,574

$82,220

$73,005

$73,984

$59,861

* Paid by U01/U10.

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

 

Total Obligations
Prior to FY 2007

FY 2007
Obligations

Total Obligations
to Date

Heart and Vascular Diseases

     

AIM HIGH:  Niacin Plus Statin To Prevent Vascular Events*

$    6,987,287

$  6,018,096

$  13,005,383

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

53,150,028

2,646,947

55,796,975

Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)*

14,837,498

3,306,675

18,144,173

Claudication:  Exercise Versus Endoluminal Revascularization (CLEVER)*

2,846,994

1,898,415

4,745,409

Efficacy of Smoking Quit Line in the Military

738,869

738,869

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

8,332,457

5,180,309

13,512,766

Heart Failure:  A Controlled Trial Investigating Outcomes of Exercise Training*

34,099,521

2,846,477

36,945,998

Heart Failure Adherence and Retention Trial (HART)

6,639,821

304,393

6,944,214

Interventions To Control Obesity in College

667,082

633,146

1,300,228

Occluded Artery Trial (OAT)

17,224,514

1,452,378

18,676,892

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

1,300,000

4,554,590

5,854,590

Reduction of Triglycerides in Women on HRT

3,275,109

625,001

3,900,110

Stop Atherosclerosis in Native Diabetics Study (SANDS)*

11,079,036

197,305

11,276,341

Surgical Treatment for Ischemic Heart Failure (STICH)*

23,482,321

9,395,837

32,878,158

Treatment of Depression Following Bypass Surgery

4,469,703

884,570

5,354,273

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

1,389,760

1,389,760

Weight Loss Maintenance (WLM)*

15,168,042

2,150,858

17,318,900

Women's Health Study (WHS)

16,922,647

735,367

17,658,014

Subtotal, Heart and Vascular Diseases

220,482,060

44,958,993

265,441,053

Lung Diseases

     

Acid Reflux Therapy in Asthma*

3,083,552

662,283

3,745,835

Adenotonsillectomy for Childhood Sleep Apnea*

2,254,440

2,387,691

4,642,131

APPLES:  Apnea Positive Pressure Long-Term Efficacy Study*

12,542,181

1,532,037

14,074,218

Childhood Asthma Management Program III (CAMP III)*

2,077,278

2,077,278

Early Insulin Therapy and Development of ARDS

489,176

489,176

Improving Asthma Care for Minority Children in Head Start

2,551,490

779,283

3,330,773

Outcomes of Sleep Disorders in Older Men

10,956,384

910,480

11,866,864

Supplemental Selenium and Vitamin E and Pulmonary Function

2,542,694

560,835

3,103,529

Subtotal, Lung Diseases

33,930,741

9,399,063

43,329,804

Blood Diseases and Resources

     

FOCUS*

8,804,219

1,974,477

10,778,696

Stroke With Transfusions Changing to Hydroxyurea (SWITCH)*

7,277,340

3,531,426

10,808,766

Subtotal,  Blood Diseases and Resources

16,081,559

5,505,903

21,587,462

TOTAL, NHLBI

$270,494,360

$59,863,959

$330,358,319

* Paid by U01/U10.

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Institute-Initiated Clinical Trials:  Fiscal Years 1997–2007

Contracts

Dollars (Thousands)

 

FY 1997

FY 1998

FY 1999

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

Heart and Vascular Diseases

                     

Lipid Research Clinics

$    650

$     685

$       —

$       —

$       —

$       —

$       —

$       —

$      —

$       —

$     —

Raynaud’s Treatment Study

19

Antiarrhythmic vs. Implantable Defibrillator (AVID)

871

548

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

15,943

17,119

6,259

7,000

3,980

2,761

3,346

Activity Counseling Trial (ACT)

2,167

2,439

Postmenopausal Estrogen/Progestin Interventions (PEPI)

3

170

Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD)

6,837

5,904

3,303

3,487

596

425

70

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

6,330

3,785

1,239

2,401

802

Beta-Blocker Evaluation Survival Trial (BEST)

2,300

2,448

Women’s Angiographic Vitamin and Estrogen Trial (WAVE)

2,891

1,917

3,878

886

756

32

Women’s Ischemia Syndrome Evaluation (WISE)

133

2,932

856

1,424

10

50

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

2,838

2,836

2,850

5,988

2,849

558

Magnesium in Coronaries (MAGIC)

1,169

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

Women’s Health Initiative

59,100

57,700

59,200

59,010

63,222

57,483

37,826

12,124

14,873

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

Subtotal, Heart and Vascular Diseases

40,111

38,490

85,132

89,050

73,021

71,334

85,164

95,445

69,114

17,915

36,575

Lung Diseases

                     

Pediatric Pulmonary and Cardiac Complications of HIV Infection (P2C2)

668

1,979

315

113

Childhood Asthma Management Program (CAMP)

5,695

6,551

729

1,330

2,786

2,287

1,475

599

Acute Respiratory Distress Syndrome Clinical Network (ARDSNET)

4,510

4,880

6,837

5,587

2,667

1,502

4,402

5,517

4,707

7,396

5,037

National Emphysema Treatment Trial (NETT)

2,710

3,367

7,545

4,047

6,989

7,910

1,630

1,648

357

Feasibility of Retinoid Treatment in Emphysema (FORTE)

884

7,711

2,429

725

507

185

Long-Term Oxygen Treatment Trial (LOTT)

6,208

Subtotal, Lung Diseases

13,583

10,226

21,817

18,389

10,986

14,740

9,044

9,147

5,848

7,396

11,245

Blood Diseases and Resources

                     

Clinical Course of Sickle Cell Disease

205

2,144

350

106

T-Cell Depletion in Unrelated Donor Marrow Transplantation

639

2,228

690

1,085

1,144

557

774

164

Viral Activation Transfusion Study (VATS)

2,353

1,668

339

Cord Blood Stem Cell Transplantation Study (COBLT)

6,573

12,530

1,456

5,122

1,846

2,166

588

707

822

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

472

475

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

Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension

1,867

2,801

Subtotal, Blood Diseases and Resources

10,242

19,045

2,965

8,258

3,395

6,411

3,468

3,971

3,688

2,758

6,767

Total, NHLBI Clinical Trials Contracts

$63,936

$67,761

$109,914

$115,697

$87,402

$92,485

$97,676

$108,563

$78,650

$28,069

$54,587

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Cooperative Agreements

Dollars (Thousands)

 

FY 1997

FY 1998

FY 1999

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

Heart and Vascular Diseases

                     

Dietary Intervention Study in Children (DISC)

$   746

$     —

$     —

$     —

$     —

$     —

$     —

$     —

$     —

$     —

$     —

Bypass Angioplasty Revascularization Investigation (BARI)

2,894

1,360

1,609

1,634

1,549

1,456

Child and Adolescent Trial for Cardiovascular Health (CATCH)

3,956

572

210

Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA)

290

Obesity Prevention in Young American Indians (PATHWAYS)

4,119

3,945

4,196

2,459

Rapid Early Action for Coronary Treatment (REACT)

2,866

496

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

Clinical Research Consortium To Improve Resuscitation Outcome

6,886

9,339

9,728

8,972

Dynamic Assessment of Patient-Reported Chronic Disease Outcomes

1,010

Clinical Trials in Organ Transplantation (CTOT)

1,900

1,855

1,801

Heart Failure Clinical Research Network

5,642

7,801

Weight Loss in Obese Adults With CVD Risk Factors

2,567

3,714

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

1,419

2,314

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

1,000

500

Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine

6,009

Cardiovascular Cell Therapy Research Network (Stem Cell)

4,424

Subtotal, Heart and Vascular Diseases

14,871

6,373

8,297

11,732

12,704

14,910

11,209

19,194

20,334

30,104

42,142

Lung Diseases

                     

Asthma Clinical Research Network (ACRN)*

4,479

8,181

8,424

8,667

7,839

8,918

Asthma and Pregnancy Studies

913

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

COPD Clinical Research Network

6,843

6,848

8,438

7,664

6,836

Idiopathic Pulmonary Fibrosis Clinical Research Network

3,486

7,349

7,216

NICHD Cooperative Multicenter Neonatal Research Network

1,336

238

Subtotal, Lung Diseases

5,392

4,175

5,002

5,314

6,005

20,634

20,564

26,295

29,923

29,124

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

Blood and Marrow Transplant Clinical Research Network

5,360

5,899

5,950

5,972

6,460

6,845

6,709

Transfusion Medicine/ Hemostasis Clinical Research Network

6,053

6,241

6,093

6,221

6,521

6,407

Sickle Cell Disease Clinical Research Network

3,761

7,498

Subtotal, Blood Diseases and Resources

2,192

7,579

14,221

14,511

14,440

15,411

19,809

23,232

Total, NHLBI-Initiated
Clinical Trials,
Cooperative Agreements

$20,263

$6,373

$12,472

$18,926

$25,597

$35,136

$46,354

$54,198

$62,040

$79,836

$94,498

Total, NHLBI-Initiated
Clinical Trials

$84,199

$74,134

$122,386

$134,623

$112,999

$127,621

$144,030

$162,761

$140,690

$107,905

$149,085

*   Investigator-Initiated from 1998 to 2002.

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

Contracts

 

Total Obligations
Prior to FY 2007

Total FY 2007
Obligations

Total Obligations
to Date

Heart and Vascular Diseases

     

Action to Control Cardiovascular Risk in Diabetes (ACCORD)

$  90,895,802

$19,484,056

$110,379,858

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

11,478,663

2,217,724

13,696,387

Women’s Health Initiative

722,565,555

14,872,780

737,438,335

Subtotal, Heart and Vascular Diseases 

824,940,020

36,574,560

861,514,580

Lung Diseases

     

Acute Respiratory Distress Syndrome Clinical Network (ARDSNET)

58,311,705

5,036,653

63,348,358

Long-Term Oxygen Treatment Trial (LOTT)

6,208,395

6,208,395

Subtotal, Lung Diseases

58,311,705

11,245,048

69,556,753

Blood Diseases and Resources

     

Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)

10,604,399

3,966,000

14,570,399

Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension

1,867,000

2,801,174

4,668,174

Subtotal, Blood Diseases and Resources 

12,471,399

6,767,174

19,238,573

Total, NHLBI-Initiated Clinical Trials, Contracts

$895,723,124

$54,586,782

$950,309,906

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 2007

Total FY 2007
Obligations

Total Obligations
to Date

Heart and Vascular Diseases

     

Cardiovascular Cell Therapy Research Network (Stem Cell)

$                   —

$    4,424,183

$       4,424,183

Clinical Research Consortium To Improve Resuscitation Outcome

25,952,727

8,971,584

34,924,311

Clinical Trials in Organ Transplantation (CTOT)

3,755,350

1,801,545

5,556,895

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

1,418,746

2,314,003

3,732,749

Heart Failure Clinical Research Network

5,642,461

7,800,582

13,443,043

Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine

6,008,848

6,008,848

Pediatric Heart Network

29,578,646

6,607,550

36,186,196

Pediatric HIV/AIDS Cohort Study—Data and Operations Center

1,000,000

500,000

1,500,000

Trial of Activity for Adolescent Girls (TAAG)

34,211,102

34,211,102

Weight Loss in Obese Adults With CVD Risk Factors

2,567,146

3,713,946

6,281,092

Subtotal, Heart and Vascular Diseases

104,126,178

42,142,241

146,268,419

Lung Diseases

     

Asthma Clinical Research Network (ACRN), Phase II

33,110,894

8,917,879

42,028,773

Childhood Asthma Research and Education (CARE) Network

42,837,293

5,915,840

48,753,133

COPD Clinical Research Network

29,793,928

6,836,458

36,630,386

Idiopathic Pulmonary Fibrosis Clinical Research Network

10,835,422

7,216,255

18,051,677

NICHD Cooperative Multicenter Neonatal Research Network

1,336,159

237,647

1,573,806

Subtotal, Lung Diseases

117,913,696

29,124,079

147,037,775

Blood Diseases and Resources

     

Blood and Marrow Transplant Clinical Research Network

36,486,721

6,708,880

43,195,601

Sickle Cell Disease Clinical Research Network

3,761,385

7,497,847

11,259,232

Thalassemia (Cooley’s Anemia) Clinical Research Network

16,787,170

2,618,369

19,405,539

Transfusion Medicine/Hemostasis Clinical Research Network

31,128,254

6,407,000

37,535,254

Subtotal, Blood Diseases and Resources

88,163,530

23,232,096

111,395,626

Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements

$   310,203,404

$  94,498,416

$      404,701,820

Total, NHLBI-Initiated Clinical Trials

$1,205,926,528

$149,085,198

$1,355,011,726

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

Obligations

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

Current Active Organizations and Contract Numbers

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

Cardiovascular Cell Therapy Research Network, Initiated in Fiscal Year 2007

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

Obligations

Funding History:
Fiscal Year 2007—$4,424,183
Total Funding to Date—$4,424,183

Current Active Organizations and Grant Numbers

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

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

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

Obligations

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

Current Active Organizations and Grant Numbers

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

Clinical Trials in Organ Transplantation (CTOT), Initiated in Fiscal Year 2005

The purpose of this program is to support a multisite consortium for interventional or observational clinical studies to enhance our understanding of, and ultimately reduce, the immune-mediated morbidity and mortality of organ transplantation.

Obligations

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

Current Active Organizations and Contract Numbers

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

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

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

Obligations

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

Current Active Organizations and Grant Numbers

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

Heart Failure Clinical Research Network, Initiated in Fiscal Year 2006

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

Obligations

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

Current Active Organizations and Grant Numbers

  1. Minneapolis Medical Research
    Foundation, Inc.
    Minneapolis, Minnesota—HL-084861
  2. Duke University
    Durham, North Carolina—HL-084875
  3. Brigham and Women’s Hospital
    Boston, Massachusetts—HL-084877
  4. University of Utah
    Salt Lake City, Utah—HL-084889
  5. Baylor College of Medicine
    Houston, Texas—HL-084890
  6. Morehouse School of Medicine
    Atlanta, Georgia—HL-084891
  7. University of Vermont and State
    Agriculture College
    Burlington, Vermont—HL-084899
  8. Duke University
    Durham, North Carolina—HL-084904
  9. Mayo Clinic College of Medicine
    Rochester, Minnesota—HL-084907
  10. Montreal Heart Institute
    Montreal, Quebec, Canada—HL-084931

Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine, Initiated in Fiscal Year 2007

The purpose of this program is to establish a network to evaluate newer surgical techniques, technologies, devices, and innovative pharmaceutical and bioengineered products directed at CVD to ensure that the public has access to the best procedures determined by careful assessment. The Network will also serve as a clinical trials training ground for fellows and junior faculty.

Obligations

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

Current Active Organizations and Grant Numbers

  1. University of Virginia, Charlottesville
    Charlottesville, Virginia—HL-088925
  2. Emory University
    Atlanta, Georgia—HL-088928
  3. Yeshiva University
    Bronx, New York—HL-088939
  4. Columbia University Health Sciences
    New York, New York—HL-088942
  5. Columbia University Health Sciences
    New York, New York—HL-088951
  6. Duke University
    Durham, North Carolina—HL-088953
  7. Case Western Reserve University
    Cleveland, Ohio—HL-088955
  8. University of Pennsylvania
    Philadelphia, Pennsylvania—HL-088957
  9. Montreal Heart Institute
    Montreal, Quebec, Canada—HL-088963

Pediatric Heart Network, Initiated in Fiscal Year 2001

The objective of this study is to establish a clinical network to evaluate novel treatment methods and man­age­ment strategies for children with structural congenital heart disease, inflammatory heart disease, heart muscle disease, or arrhythmias.

Obligations

Funding History:
Fiscal Year 2007—$6,607,550
Fiscal Years 2001–2006—$29,578,646
Total Funding to Date—$36,186,196

Current Active Organizations and Grant Numbers

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

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

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

Obligations

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

Current Active Organization and Grant Number

  1. Harvard University
    Boston, Massachusetts—HD-052102

Trial of Activity for Adolescent Girls (TAAG), Initiated in Fiscal Year 2000

The purpose of this community-based study is to test the effects of a school–community-linked intervention to prevent decline in physical activity and cardiorespiratory fitness seen during adolescence in girls. The study is being conducted in 36 schools; 43 percent of the population are minorities.

Obligations

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

Current Active Organizations and Grant Numbers

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

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

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

Obligations

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

Current Active Organization and Contract Number

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

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

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

Obligations

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

Current Active Organizations and Grant Numbers

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

Women’s Health Initiative, Initiated in Fiscal Year 1992

The purpose of the WHI is to study cardiovascular disease, cancer, and osteoporosis in postmenopausal women. The program consists of three major components: a randomized controlled clinical trial of HRT, dietary modification, and calcium/vitamin D supplementation; an observational study to identify predictors of disease; and a study of community approaches to developing healthful behaviors.

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

Obligations

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

*This figure reflects funding for the clinical trials and observational studies only. From 1992 to 1998, major support was provided through the Office of the Director, NIH. The Community Prevention Study receives funding through an inter-Agency agreement with the CDC: $4,000,000 in FY 1999 and $12,000,000 from FY 1996–98.

Current Active Organizations and Contract Numbers

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

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Lung Diseases Program

Acute Respiratory Distress Syndrome Clinical Network (ARDSNet), Initiated in Fiscal Year 1994

The purpose of this network is to develop and conduct randomized controlled clinical trials to prevent, treat, and improve the outcome of patients with acute lung injury, ARDS, and other related critical illnesses.

Obligations

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

Current Active Organizations and Contract Numbers

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

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

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

Obligations

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

Current Active Organizations and Grant Numbers

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

Childhood Asthma Research and Education (CARE) Network, Initiated in Fiscal Year 1999

The purpose of this clinical network is to evaluate current and novel therapies and management strategies for children with asthma. Emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.

Obligations

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

Current Active Organizations and Grant Numbers

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

COPD Clinical Research Network, Initiated in Fiscal Year 2003

The purpose of this network is to investigate disease management approaches in patients with moderate-to-severe COPD and to ensure that the findings are rapidly disseminated to the medical community.

Obligations

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

Current Active Organizations and Grant Numbers

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

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

The purpose of this network is to establish (1) six to seven clinical centers to design and perform multiple therapeutic trials for treatment of patients with newly diagnosed idiopatic pulmonary fibrosis and (2) a Data Coordinating Center for the network.

Obligations

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

Current Active Organizations and Contract Numbers

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

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

The purpose of this program is to determine the effectiveness and safety of long-term, home-administered oxygen therapy in patients with COPD. Approximately 3,500 patients with moderate COPD will be enrolled to determine whether supplemental oxygen can improve their quality of life and extend their lifespan. Research findings will help Medicare decide whether to extend coverage for home oxygen treatment for patients with moderate disease.

Obligations

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

Current Active Organizations and Grant Numbers

  1. Brigham and Women’s Hospital
    Boston, Massachusetts—HR-76183
  2. Cleveland Clinic Foundation
    Cleveland, Ohio—HR-76184
  3. Denver Health and Hospital Authority
    Denver, Colorado—HR-76185
  4. Duke University Medical Center
    Durham, North Carolina—HR-76186
  5. Kaiser Foundation Hospitals
    Portland, Oregon—HR-76187
  6. Los Angeles Biomedical
    Institute/Harbor-UCLA
    Los Angeles, California—HR-76188
  7. The Ohio State University
    Columbus, Ohio—HR-76189
  8. Temple University
    Philadelphia, Pennsylvania—HR-76190
  9. University of Alabama at Birmingham
    Birmingham, Alabama—HR-76191
  10. University of Michigan
    Ann Arbor, Michigan—HR-76192
  11. University of Pittsburgh
    Pittsburgh, Pennsylvania—HR-76193
  12. University of Utah
    Salt Lake City, Utah—HR-76194
  13. University of Washington
    Seattle, Washington—HR-76195
  14. Washington University
    St. Louis, Missouri—HR-76196
  15. Johns Hopkins University
    Baltimore, Maryland—HR-76197

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

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

Obligations

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

Current Active Organizations and Grant Numbers

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

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Blood Diseases and Resources Program

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

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

Obligations

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

Current Active Organizations and Grant Numbers

  1. University of Nebraska Medical Center
    Omaha, Nebraska—HL-069233
  2. Fred Hutchinson Cancer Research Center
    Seattle, Washington—HL-069246
  3. Dana Farber Cancer Institute
    Boston, Massachusetts—HL-069249
  4. National Childhood Cancer Foundation
    Arcadia, California—HL-069254
  5. University of California, San Diego
    La Jolla, California—HL-069273
  6. Duke University
    Durham, North Carolina—HL-069274
  7. City of Hope Medical Center
    Duarte, California—HL-069278
  8. University of Pennsylvania
    Philadelphia, Pennsylvania—HL-069286
  9. University of Minnesota, Twin Cities
    Minneapolis, Minnesota—HL-069290
  10. Stanford University
    Stanford, California—HL-069291
  11. Medical College of Wisconsin
    Milwaukee, Wisconsin—HL-069294
  12. University of Florida
    Gainesville, Florida—HL-069301
  13. Johns Hopkins University
    Baltimore, Maryland—HL-069310
  14. Sloan Kettering Institute for Cancer Research
    New York, New York—HL-069315
  15. University of Michigan at Ann Arbor
    Ann Arbor, Michigan—HL-069330
  16. University of Texas
    M.D. Anderson Cancer Center
    Houston, Texas—HL-069334
  17. Case Western Reserve University
    Cleveland, Ohio—HL-069348

Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG), Initiated in Fiscal Year 2000

The objective of this clinical trial is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.

Obligations

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

Current Active Organizations and Contract Numbers

  1. Children’s Research Institute
    Washington, DC—HB-07150
  2. Duke University Medical Center
    Durham, North Carolina—HB-07151
  3. Howard University
    Washington, DC—HB-07152
  4. Johns Hopkins University
    Baltimore, Maryland—HB-07153
  5. Medical University of South Carolina
    Charleston, South Carolina—HB-07154
  6. St. Jude Children’s Research Hospital
    Memphis, Tennessee—HB-07155
  7. The Research Foundation of SUNY
    New York, New York—HB-07156
  8. University of Miami
    Miami, Florida—HB-07157
  9. University of Mississippi Medical Center
    Jackson, Mississippi—HB-07158
  10. University of Texas
    Southwestern Medical Center
    Dallas, Texas—HB-07159
  11. Clinical Trials and Surveys Corporation
    Baltimore, Maryland—HB-07160

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

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

Obligations

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

Current Active Organizations and Contract Numbers

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

Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension, Initiated in Fiscal Year 2006

The purpose of this clinical trial is to evaluate the safety and efficacy of 18 weeks of therapy with sildenafil, a nitric oxide potentiator, in adult patients with SCD and pulmonary hypertension; exercise endurance and pulmonary artery pressure will be measured. Pulmonary hypertension occurs in up to 30 percent of SCD cases and is strongly associated with mortality in adults with SCD.

Obligations

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

Current Active Organizations and Contract Numbers

  1. Rho Federal Systems Division, Inc.
    Chapel Hill, North Carolina—HB-67182
  2. Imperial College of London
    London, England—HB-67183
  3. Children’s Hospital of Pittsburgh
    Pittsburgh, Pennsylvania—HB-67184
  4. University of Colorado
    Denver, Colorado—HB-67185
  5. Children’s Hospital and Research Center
    at Oakland
    Oakland, California—HB-67186
  6. University of Illinois at Chicago
    Chicago, Illinois—HB-67187
  7. Johns Hopkins University
    Baltimore, Maryland—HB-67188
  8. Howard University
    Washington, DC—HB-67189
  9. Albert Einstein College of Medicine
    New York, New York—HB-67190

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

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

Obligations

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

Current Active Organizations and Grant Numbers

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

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

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

Obligations

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

Current Active Organizations and Grant Numbers

  1. University of Iowa
    Iowa City, Iowa—HL-072028
  2. Case Western Reserve University
    Cleveland, Ohio—HL-072033
  3. University of Minnesota, Twin Cities
    Minneapolis, Minnesota—HL-072072
  4. Johns Hopkins University
    Baltimore, Maryland—HL-072191
  5. Weill Medical College of
    Cornell University
    New York, New York—HL-072196
  6. Emory University
    Atlanta, Georgia—HL-072248
  7. New England Research Institutes, Inc.
    Watertown, Massachusetts—HL-072268
  8. Tulane University of Louisiana
    New Orleans, Louisiana—HL-072274
  9. University of Oklahoma
    Health Sciences Center
    Oklahoma City, Oklahoma—HL-072283
  10. Duke University
    Durham, North Carolina—HL-072289
  11. Blood Center of Southeastern Wisconsin
    Milwaukee, Wisconsin—HL-072290
  12. Children’s Hospital
    Boston, Massachusetts—HL-072291
  13. Massachusetts General Hospital
    Boston, Massachusetts—HL-072299
  14. Puget Sound Blood Center
    Seattle, Washington—HL-072305
  15. University of Pittsburgh
    Pittsburgh, Pennsylvania—HL-072331
  16. University of Pennsylvania
    Philadelphia, Pennsylvania—HL-072346
  17. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina—HL-072355
  18. University of Maryland
    Baltimore Professional School
    Baltimore, Maryland—HL-072359

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