Skip banner and top navigation
NHLBI Logo and Link
National Heart, Lung, and Blood Institute: People, Science, Health
 TEXT SIZE: 
 HOME  SITE INDEX  CONTACT US
  
About NHLBI
Link to the National Institutes of Health Link to the Department of Health and Human Services

« 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.

Back to Top

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