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« 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 19972007
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 |
|
|
|
|
|
|
|
Womens 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 |
|
|
|
|
|
|
|
|
|
|
|
Womens 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 |
|
|
|
|
|
|
|
|
Womens 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 |
|
Womens 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
ProgramContinuation 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
| |