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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 1995–2005

  Research Grants and Cooperative Agreements (Dollars in Thousands)
  Fiscal Year
  1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Heart and Vascular Diseases                      
Program on Surgical Control of Hyperlipidemias (POSCH)
$538 $566 $294 $--- $--- $--- $--- $--- $--- $--- $---
Emory Angioplasty Versus Surgery Trial (EAST)
296 296 --- --- --- --- --- --- --- --- ---
Asymptomatic Carotid Artery Plaque Study (ACAPS)
66 70                  
Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest
598 699 685 582 584 392 75 --- --- --- ---
Multicenter Unsustained Tachycardia Trial*
1,958 504 --- --- --- --- --- --- --- --- ---
Women’s Health Study (WHS)
1,426 1,434 1,473 1,536 1,530 1,594 --- --- --- --- 889
Cardiovascular Risk Factors and the Menopause
451 478 494 528 186 --- --- --- --- --- ---
Sodium Sensitivity in African Americans
249 --- --- --- --- --- --- --- --- --- ---
Stress Reduction in Elderly Blacks With Hypertension
321 --- --- --- --- --- --- --- --- --- ---

Trial of Nonpharmacologic Intervention in the Elderly (TONE)

729 --- --- --- --- --- --- --- --- --- ---
CABG Patch Trial*
1,344 988 1,171 --- --- --- --- --- --- --- ---
Women’s Antioxidant and Cardiovascular Study (WACS)
620 643 501 525 540 556 572 598 592 599 670
Oral Calcium in Pregnant Women With Hypertension
306 320 332 --- --- --- --- --- --- --- ---
Stress Reduction and Atherosclerotic CVD in Blacks
330 403 407 40 326 339 360 376 394 --- ---
Enalapril After Anthracycline Cardiotoxicity
647 707 724 789 --- --- --- --- --- --- ---
Stress and Anger Management for Blacks With Hypertension
232 241 250 --- --- --- --- --- --- --- ---
Estrogen Replacement and Atherosclerosis (ERA) Trial*
260 1,213 965 1,668 1,017 --- --- --- --- --- ---
Shock Trial: Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock?
1,022 1,008 826 874 --- 440 362 298 291 296 ---
HDL-Atherosclerosis Treatment Study
480 427 445 340 --- 326 --- --- --- --- ---
Influence of Cardiopulmonary Bypass (CPB) Temperature on CABG Morbidity
107 118 --- --- --- --- --- --- --- --- ---
Women’s Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)*
798 508 1,196 1,269 1,131 --- 32 --- --- --- ---
Mode Selection Trial in Sinus Node Dysfunction (MOST)*
2,163 1,857 2,096 1,700 2,879 1,136 154 --- --- --- ---
Antioxidants and Prevention of Early Atherosclerosis*
793 240 603 --- --- --- --- --- --- --- ---
Postmenopausal Hormone Therapy in Unstable Angina
253 258 264 271 276 --- --- --- --- --- ---
Estrogen and Graft Atherosclerosis Research Trial (EAGER)*
--- 476 488 305 --- 361 371 --- --- --- ---
Soy Estrogen Alternative Study (SEA)
--- 219 217 221 --- --- --- --- --- --- ---
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 --- ---
Bypass Angioplasty Revascularization Investigation in Type 2 Diabetics (BARI 2D)*
--- --- --- --- --- 3,942 6,515 9,342 8,189 8,265 8,304
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
Reduction of Triglycerides in Women on HRT
--- --- --- --- --- --- 708 746 555 544 721
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
Clinical Trial of Dietary Protein on Blood Pressure
--- --- --- --- --- --- --- 655 610 612 504
Home Automatic External Defibrillator Trial (HAT)*
--- --- --- --- --- --- --- 3,567 5,433 4,264 1,801
Perioperative Interventional Neuroprotection Trial (POINT)
--- --- --- --- --- --- --- 553 553 562 572
Stop Atherosclerosis in Native Diabetics Study (SANDS)*
--- --- --- --- --- --- --- 2,410 2,165 2,107 2,324
Surgical Treatment for Ischemic Heart Failure (STICH)*
--- --- --- --- --- --- --- 5,709 4,495 1,613 6,082
Girls Health Enrichment Multisite Studies (GEMS)*
--- --- --- --- --- --- --- --- 2,461 2,400 2,370
Treatment of Depression Following Bypass Surgery
--- --- --- --- --- --- --- --- 964 1,132 1,181
Weight Loss Maintenance (WLM)*
--- --- --- --- --- --- --- --- 3,687 4,368 3,099
Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)*
--- --- --- --- --- --- --- --- --- 4,343 5,610

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

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NHLBI Investigator-Initiated Clinical Trials: Fiscal Years 1995–2005 (continued)
  Research Grants and Cooperative Agreements (Dollars in Thousands)
  Fiscal Year
  1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Heart and Vascular Diseases (continued)                      
FREEDOM Trial: Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optional Management of Multivessel Disease
--- --- --- --- --- --- --- --- --- 3,663 4,669
IMMEDIATE Trial: Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care*
--- --- --- --- --- --- --- --- --- 5,170 9,514
AIM HIGH: Niacin Plus Statin To Prevent Vascular Events*
--- --- --- --- --- --- --- --- --- --- 663
Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)*
--- --- --- --- --- --- --- --- --- --- 1,368
Subtotal, Heart and Vascular Diseases 15,987 13,673 19,483 23,265 29,111 26,578 22,996 45,253 50,163 52,377 56,681
Lung Diseases                      
Cardiopulmonary Effects of Ibuprofen in Human Sepsis*
--- --- --- --- --- --- --- --- --- --- ---
Inhaled Beclomethasone To Prevent Chronic Lung Disease*
738 551 436 --- --- --- --- --- --- --- ---
Lung Health Study II*†
4,434 3,183 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 --- ---
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
Childhood Asthma Management Program–Continuation Study (CAMP–CS)/Phase 2*†
--- --- --- --- --- --- --- --- 1,489 2,043 2,623
Clinical Trial of Acid Reflux Therapy in Asthma*
--- --- --- --- --- --- --- --- 736 783 791
Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)
--- --- --- --- --- --- --- --- 682 612 608
Outcomes of Sleep Disorders in Older Men
--- --- --- --- --- --- --- --- 4,163 4,262 1,390
Supplemental Selenium and Vitamin E and Pulmonary Function
--- --- --- --- --- --- --- --- 698 610 630
Improving Asthma Care in Minority Children in Head Start
--- --- --- --- --- --- --- --- --- 721 826
Subtotal, Lung Diseases 5,172 3,734 3,944 7,911 8,844 15,484 17,076 18,974 15,639 14,289 10,056
Blood Diseases and Resources                      
Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia—Phase II*
1,238 --- --- --- --- --- --- --- --- --- ---
Trial To Reduce Alloimmunization to Platelets (TRAP)—Extension†
1,246 263 --- --- --- --- --- --- --- --- ---
Stroke Prevention in Sickle Cell Anemia (STOP)*
3,257 2,435 2,584 2,036 --- 293 --- --- --- --- ---
Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG)
250 260 270 --- --- --- --- --- --- --- ---
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
Stroke With Transfusions Changing to Hydroxyurea (SWITCH)*
--- --- --- --- --- --- --- --- --- --- 3,345
Subtotal, Blood Diseases and Resources 5,991 2,958 2,854 2,036 --- 4,493 4,877 4,917 5,772 6,066 6,268
Total, NHLBI $27,150 $20,365 $26,281 $33,212 $37,955 $46,555 $44,949 $69,144 $71,574 $82,220 $73,005

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

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NHLBI Investigator-Initiated Clinical Trials: Fiscal Years 1995–2005

NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2005: Summary by Program
  Total Obligations Prior to FY 2005 FY 2005 Obligations Total Obligations to Date
Heart and Vascular Diseases      
AIM HIGH: Niacin Plus Statin To Prevent Vascular Events*
--- 663,376 663,376
Bypass Angioplasty Revascularization Investigation in Type 2 Diabetics (BARI 2D)*
36,253,973 8,304,235 44,558,208
Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)*
4,343,389 5,610,035 9,953,424
Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)
--- 1,368,413 1,368,413
Clinical Trial of Dietary Protein on Blood Pressure
1,877,176 504,047 2,381,223
FREEDOM Trial: Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease
3,663,095 4,669,362 8,332,457
Girls Health Enrichment Multisite Studies*
4,861,435 2,369,517 7,230,952
Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)*
25,025,952 4,483,140 29,509,092
Heart Failure Adherence and Retention Trial (HART)
5,038,583 861,475 5,900,058
Home Automatic External Defibrillator Trial (HAT)*
13,263,642 1,800,742 15,064,384
IMMEDIATE Trial: Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care*
5,170,411 9,513,736 14,684,147
Perioperative Interventional Neuroprotection Trial (POINT)
1,668,047 571,974 2,240,021
Reduction of Triglycerides in Women on HRT
2,554,495 720,614 3,275,109
Stop Atherosclerosis in Native Diabetics Study (SANDS)*
6,681,337 2,323,642 9,004,979
Surgical Treatment for Ischemic Heart Failure (STICH)*
11,817,086 6,082,190 17,899,276
Treatment of Depression Following Bypass Surgery
2,096,012 1,180,897 3,276,909
Weight Loss Maintenance (WLM)*
8,054,488 3,098,894 11,153,382
Women’s Antioxident and Cardiovasular Study (WACS)
6,942,751 669,855 7,612,606
Women’s Health Study (WHS)
16,033,881 888,766 16,922,647
Women’s Ischemia Syndrome Evaluation (WISE)*†
5,617,360 995,753 6,613,113
Subtotal, Heart and Vascular Diseases 160,963,113 56,680,663 217,643,776
Lung Diseases      
Acid Reflux Therapy in Asthma*
1,519,544 791,142 2,310,686
APPLES: Apnea Positive Pressure Long-Term Efficacy Study*
9,354,009 3,188,172 12,542,181
Childhood Asthma Management Program II (CAMP II)*
3,532,802 2,622,721 6,155,523
Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)
1,294,011 608,093 1,902,104
Improving Asthma Care for Minority Children in Head Start
721,025 825,110 1,547,135
Outcomes of Sleep Disorders in Older Men
8,424,494 1,389,672 9,814,166
Supplemental Selenium and Vitamin E and Pulmonary Function
1,308,074 630,237 1,938,311
Subtotal, Lung Diseases 26,153,959 10,056,147 36,210,106
Blood Diseases and Resources      
FOCUS*
3,435,202 2,922,730 6,357,932
Stroke With Transfusions Changing to Hydroxyurea (SWITCH)*
--- 3,345,345 3,345,345
Subtotal, Blood Diseases and Resources 3,435,202 6,268,075 9,703,277
Total, NHLBI $190,552,274 $73,004,885 $263,557,159

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

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Institute-Initiated Clinical Trials: Fiscal Years 1995–2005

Contracts

  Dollars (Thousands)
  Fiscal Year
  1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Heart and Vascular Diseases                      
Lipid Research Clinics
$583 $660 $650 $685 $--- $--- $--- $--- $--- $--- $---
Effects of Digitalis on Survival in Patients With Congestive Heart Failure
2,235 --- --- --- --- --- --- --- --- --- ---
Asymptomatic Cardiac Ischemia Pilot Study (ACIP)
7 --- --- --- --- --- --- --- --- --- ---
Psychophysiological Investigations of Myocardial Ischemia (PIMI)
165 --- --- --- --- --- --- --- --- --- ---
Arterial Disease Multifactorial Intervention
395 --- --- --- --- --- --- --- --- --- ---
Raynaud’s Treatment Study
1,664 221 19 --- --- --- --- --- --- --- ---
Antiarrhythmic vs. Implantable Defibrillator (AVID)
5,348 2,475 --- 871 548 --- --- --- --- --- ---
Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
3,412 9,676 15,943 17,119 --- 6,259 7,000 3,980 2,761 3,346 ---
Activity Counseling Trial (ACT)
5,000 --- 2,167 2,439 --- --- --- --- --- --- ---
Postmenopausal Estrogen/Progestin Interventions (PEPI)
1,305 --- 3 170 --- --- --- --- --- --- ---
Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD)
1,871 6,993 6,837 5,904 3,303 3,487 596 425 70 --- ---
Atrial Fibrillation Follow-up: Investigation in Rhythm Management (AFFIRM)
883 2,510 6,330 --- 3,785 1,239 2,401 802 --- --- ---
Beta-Blocker Evaluation Survival Trial (BEST)
2,500 1,435 2,300 2,448 --- --- --- --- --- --- ---
Women’s Angiographic Vitamin and Estrogen Trial (WAVE)
--- 731 2,891 1,917 3,878 886 756 --- 32 --- ---
Women’s Ischemia Syndrome Evaluation (WISE)
--- 1,577 133 2,932 856 1,424 10 50 --- --- ---
Prevention of Events With Angiotensin Converting Enzyme Inhibitor Therapy (PEACE)
--- 3,632 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 --- --- ---
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
--- --- --- --- 4,130 6,590 --- 1,750 18,521 33,779 26,126
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)
--- --- --- --- --- --- --- --- --- 897 5,126
Subtotal, Heart and Vascular Diseases 25,368 29,910 40,111 38,490 26,032 31,350 13,350 13,821 12,324 21,942 31,288
Lung Diseases                      
Lung Health Study I
650 350 --- --- --- --- --- --- --- --- ---
Pediatric Pulmonary and Cardiac Complications of HIV Infection (P2C2)
2,627 4,033 668 1,979 --- 315 --- 113 --- --- ---
Childhood Asthma Management Program (CAMP)
5,096 7,977 5,695 --- 6,551 729 1,330 2,786 2,287 1,475 599
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)
4,170 4,337 4,510 4,880 6,837 5,587 2,667 1,502 4,402 5,517 4,707
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
Subtotal, Lung Diseases 12,543 16,697 13,583 10,226 21,817 18,389 10,986 14,740 9,044 9,147 5,848
Blood Diseases and Resources                      
Clinical Course of Sickle Cell Disease
4,375 376 205 2,144 350 106 --- --- --- --- ---
Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission
1,819 706 --- --- --- --- --- --- --- --- ---
T-Cell Depletion in Unrelated Donor Marrow Transplantation
1,917 1,461 639 2,228 690 1,085 1,144 557 774 164 ---
Viral Activation Transfusion Study (VATS)
5,000 5,647 2,353 1,668 --- 339 --- --- --- --- ---
Cord Blood Stem Cell Transplantation Study (COBLT)
--- 1,419 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
--- 703 472 475 469 --- --- 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
Subtotal, Blood Diseases and Resources 13,111 10,312 10,242 19,045 2,965 8,258 3,395 6,411 3,468 3,971 3,688
Women’s Health Initiative                      
Subtotal, Women’s Health Initiative --- --- --- --- 59,100 57,700 59,200 59,010 63,222 57,483 37,826
Total, NHLBI Clinical Trials Contracts $51,022 $56,919 $63,936 $67,761 $109,914 $115,697 $87,402 $92,485 $97,676 $108,563 $78,650

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Institute-Initiated Clinical Trials: Fiscal Years 1995–2005 (continued)

Cooperative Agreements

  Dollars (Thousands)
  Fiscal Year
  1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Heart and Vascular Diseases                      
Trials of Hypertension Prevention (TOHP)
$1,240 $649 $--- $--- $--- $--- $--- $--- $--- $--- $---
Dietary Intervention Study in Children (DISC)
1,625 1,625 746 --- --- --- --- --- --- --- ---
Bypass Angioplasty Revascularization Investigation (BARI)
3,882 2,757 2,894 1,360 1,609 1,634 1,549 1,456 --- --- ---
Postmenopausal Estrogen/Progestin Interventions (PEPI)
584 331 --- --- --- --- --- --- --- --- ---
Child and Adolescent Trial for Cardiovascular Health (CATCH)
2,342 2,682 3,956 572 210 --- --- --- --- --- ---
Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA)
2,485 132 290 --- --- --- --- --- --- --- ---
Obesity Prevention in Young American Indians (PATHWAYS)
2,150 3,432 4,119 3,945 4,196 2,459 --- --- --- --- ---
Dietary Approaches To Stop Hypertension (DASH)
2,513 899 --- --- --- --- --- --- --- --- ---
Rapid Early Action for Coronary Treatment (REACT)
5,091 4,992 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
Pediatric Cardiovascular Clinical Research Network
--- --- --- --- --- --- 3,447 4,822 5,381 4,948 3,992
Clinical Research Consortium To Improve Resuscitation Outcome
--- --- --- --- --- --- --- --- --- 6,886 9,339
Dynamic Assessment of Patient-Reported Chronic Disease Outcomes
--- --- --- --- --- --- --- --- --- 1,010 ---
Clinical Trials in Organ Transplantation (CTOT)
--- --- --- --- --- --- --- --- --- --- 1,900
Subtotal, Heart and Vascular Diseases 21,912 17,499 14,871 6,373 8,297 11,732 12,704 14,910 11,209 19,194 20,334
Lung Diseases                      
Asthma Clinical Research Network (ACRN)*
3,640 4,526 4,479 --- --- --- --- --- 8,181 8,424 8,667
Asthma and Pregnancy Studies
991 1,000 913 --- --- --- --- --- --- --- ---
Childhood Asthma Research and Education (CARE) Network
--- --- --- --- 4,175 5,002 5,314 6,005 5,610 5,292 5,704
COPD Clinical Research Network
--- --- --- --- --- --- --- --- 6,843 6,848 8,438
Idiopathic Pulmonary Fibrosis Clinical Research
--- --- --- --- --- --- --- --- --- --- 3,486
Subtotal, Lung Diseases 4,631 5,526 5,392 --- 4,175 5,002 5,314 6,005 20,634 20,564 26,295
Blood Diseases and Resources                      
Thalassemia (Cooley’s Anemia) Clinical Research Network
--- --- --- --- --- 2,192 2,219 2,269 2,320 2,375 2,730
Blood and Marrow Transplant Clinical Research Network
--- --- --- --- --- --- 5,360 5,899 5,950 5,292 6,460
Transfusion Medicine/Hemostasis Clinical Research Network
--- --- --- --- --- --- --- 6,053 6,241 6,093 6,221
Subtotal, Blood Diseases and Resources --- --- --- --- --- 2,192 7,579 14,221 14,511 14,440 15,411
Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements $26,543 $23,025 $20,263 $6,373 $12,472 $18,926 $25,597 $35,136 $46,354 $54,198 $62,040
Total, NHLBI-Initiated Clinical Trials $77,565 $79,944 $84,199 $74,134 $122,386 $134,623 $112,999 $127,621 $144,030 $162,761 $140,690

* Investigator-Initiated from 1998 to 2002.

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Institute-Initiated Clinical Trials, Fiscal Year 2005: Summary by Program

Contracts

  Total Obligations Prior to FY 2005 Total FY 2005 Obligations Total Obligations to Date
Heart and Vascular Diseases      
Action To Control Cardiovascular Risk in Diabetes (ACCORD)
$64,769,478 $26,126,324 $90,895,802
Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT)
83,170,059 --- 83,170,059
Trial of Aldosterone Antagonists Therapy in Adults With Ejection Fraction Congestive Heart Failure (TOPCAT)
837,227 5,161,746 5,998,973
Subtotal, Heart and Vascular Diseases 148,776,764 31,288,070 180,064,834
Lung Diseases      
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)
46,208,966 4,706,675 50,915,641
Childhood Asthma Management Program (CAMP)
56,320,611 599,206 56,919,817
Feasibility of Retinoid Treatment in Emphysema (FORTE)
12,256,041 185,012 12,441,053
National Emphysema Treatment Trial (NETT)
35,846,310 357,270 36,203,580
Subtotal, Lung Diseases 150,631,928 5,848,163 156,480,091
Blood Diseases and Resources      
Cord Blood Stem Cell Transplantation Study (COBLT)
32,406,365 822,243 33,228,608
Multicenter Study of Hydroxyurea (MSH) in Sickle Cell Anemia Adult Follow-up
4,836,836 1,340,090 6,176,926
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
8,187,198 1,526,201 9,713,399
Subtotal, Blood Diseases and Resources 45,430,399 3,688,534 49,118,933
Women’s Health Initiative      
Subtotal, Women’s Health Initiative 672,615,477 37,826,017 710,441,494
Total, NHLBI-Initiated Clinical Trials, Contracts $1,017,454,468 $78,650,784 $1,096,105,352

Cooperative Agreements

  Total Obligations Prior to FY 2005 Total FY 2005 Obligations Total Obligations to Date
Heart and Vascular Diseases      
Clinical Research Consortium To Improve Resuscitation Outcome
$6,886,109 $9,338,606 $16,224,715
Clinical Trials in Organ Transplantation (CTOT)
--- 1,900,000 1,900,000
Dynamic Assessment of Patient-Reported Chronic Disease Outcomes
1,009,694 --- 1,009,694
Pediatric Cardiovascular Clinical Research Network
18,598,211 3,992,212 22,590,423
Trial of Activity for Adolescent Girls (TAAG)
28,202,937 5,102,829 33,305,766
Subtotal, Heart and Vascular Diseases 54,696,951 20,333,647 75,030,598
Lung Diseases      
Asthma Clinical Research Network
16,605,558 8,667,026 25,272,584
Childhood Asthma Research and Education (CARE) Network
31,398,337 5,704,202 37,102,539
COPD Clinical Research Network
13,691,750 8,437,795 22,129,545
Idiopathic Pulmonary Fibrosis Clinical Research Network
--- 3,486,226 3,486,226
Subtotal, Lung Diseases 61,695,645 26,295,249 87,990,894
Blood Diseases and Resources      
Blood and Marrow Transplant Clinical Research Network
23,181,808 6,459,743 29,641,551
Thalassemia (Cooley’s Anemia) Clinical Research Network
11,374,688 2,729,989 14,104,677
Transfusion Medicine/Hemostasis Clinical Research Network
18,386,476 6,221,140 24,607,616
Subtotal, Blood Diseases and Resources 52,942,972 15,410,872 68,353,844
Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements $169,335,568 $62,039,768 $231,375,336
Total, NHLBI-Initiated Clinical Trials $1,169,335,568 $140,690,552 $1,327,480,688

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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 2005—$26,126,324
   Fiscal Years 1999–2004—$64,769,478
Total Funding to Date—$90,895,802

Current Active Organizations and Contract Numbers
  1. Veterans Affairs Medical Center, Albuquerque
    Albuquerque, New Mexico
—HC-10100
  1. Veterans Affairs Medical Center, Memphis
    Memphis, Tennessee
—HC-90350
  1. Wake Forest University
    Winston-Salem, North Carolina
—HC-95178
  1. McMaster University
    Hamilton, Ontario
—HC-95179
  1. University of Washington
    Seattle, Washington
—HC-95180
  1. Case Western Reserve University
    Cleveland, Ohio
—HC-95181
  1. Wake Forest University
    Winston-Salem, North Carolina
—HC-95182
  1. Minneapolis Medical Research Foundation
    Minneapolis, Minnesota
—HC-95183
  1. Trustees of Columbia University of New York
    New York, New York
—HC-95184

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Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT), Initiated in Fiscal Year 1993

The ALLHAT is a practice-based, randomized clinical trial to determine whether combined incidence of fatal CHD and nonfatal MI differs between diuretic-based and newer antihypertensive treatments (ACE inhibitor, calcium channel blocker, alpha blocker) in high-risk hypertensive patients. The objective of the lipid-lowering component of the study is to determine whether lowering serum cholesterol with an HMG CoA reductase inhibitor reduces the total mortality in a subset of hypertensive patients with moderately elevated LDL cholesterol. Because blacks and Hispanics are at high risk for hypertension and CHD, investigators recruited a high percentage of minorities into the study.

In February 2000, the alpha blocker arm of the study was discontinued at the recommendation of the Data Safety Monitoring Committee and an independant expert review committee because the CVD event rate was significantly greater among those patients compared to the control group.

Obligations

Funding History:
   Fiscal Year 2005—$0
   Fiscal Years 1993–2004—$83,170,059
Total Funding to Date—$83,170,059

Current Active Organization and Contract Number
  1. University of Texas Health Science Center
    Houston, Texas
—HC-35130

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 2005—$9,338,606
   Fiscal Year 2004—$6,886,109
Total Funding to Date—$16,224,715

Current Active Organizations and Grant Numbers
  1. University of Washington
    Seattle, Washington
—HL-077863
  1. University of Iowa
    Iowa, City, Iowa
—HL-077865
  1. Medical College of Wisconsin
    Milwaukee, Wisconsin
—HL-077866
  1. University of Washington
    Seattle, Washington
—HL-077867
  1. University of Pittsburgh
    Pittsburgh, Pennsylvania
—HL-077871
  1. St. Michael’s Hospital
    Toronto, Ontario
—HL-077872
  1. Oregon Health and Science University
    Portland, Oregon
—HL-077873
  1. University of Alabama at Birmingham
    Birmingham, Alabama
—HL-077881
  1. Ottawa Health Research Institute
    Ottawa, Ontario
—HL-077885
  1. University of Texas Southwestern Medical Center
    Dallas, Texas
—HL-077887
  1. University of California, San Diego
    La Jolla, California
—HL-077908

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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 2005—$1,900,000
Total Funding to Date—$1,900,000

Current Active Organizations and Contract Numbers
  1. University of Pennsylvania
    Philadelphia, Pennsylvania
—AI-063589
  1. Cleveland Clinic Lerner College of Medicine-Case Western Reserve University
    Cleveland, Ohio
—AI-063594
  1. Brigham and Women's Hospital
    Boston, Massachusetts
—AI-063623

Dynamic Assessment of Patient-Reported Chronic Disease Outcomes, Initiated in Fiscal Year 2004

The purpose of this study, which emanates from a NIH Roadmap Initiative, is to develop a computerized system of patient-reported outcomes that will meet the needs of clinical researchers across a wide variety of chronic disorders and diseases. Investigators will develop and test a large bank of items measuring patient-reported outcomes; create a computerized adaptive testing system that will allow for efficient assessment of patient-reported outcomes in clinical research; and create a publicly available system that can be added to and modified periodically for clinical researchers.

Obligations

Funding History:
   Fiscal Year 2005—$0
   Fiscal Year 2004—$1,009,694
Total Funding to Date—$1,009,694

Current Active Organizations and Grant Numbers
  1. University of Pittsburgh
    Pittsburgh, Pennsylvania
—AR-52155
  1. Stanford University
    Stanford, California
—AR-52158
  1. State University New York, Stony Brook
    Stony Brook, New York
—AR-52170
  1. University of Washington
    Seattle, Washington
—AR-52171
  1. Evanston Northwestern Healthcare
    Evanston, Illinois
—AR-52177
  1. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina
—AR-52181
  1. Duke University
    Durham, North Carolina
—AR-52186

Pediatric Cardiovascular Clinical Research 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 2005—$3,992,212
   Fiscal Years 2001–2004—$18,598,211
Total Funding to Date—$22,590,423

Current Active Organizations and Grant Numbers
  1. Duke University
    Durham, North Carolina
—HL-068269
  1. New England Research Institute, Inc.
    Watertown, Massachusetts
—HL-068270
  1. Children’s Hospital of Philadelphia
    Philadelphia, Pennsylvania
—HL-068279
  1. Medical University of South Carolina
    Charleston, South Carolina
—HL-068281
  1. Children’s Hospital
    Boston, Massachusetts
—HL-068285
  1. Hospital for Sick Children
    Toronto, Ontario
—HL-068288
  1. Columbia University Health Sciences
    New York, New York
—HL-068290
  1. University of Utah
    Salt Lake City, Utah
—HL-068292

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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 2005—$5,102,829
   Fiscal Years 2000–2004—$28,202,937
Total Funding to Date—$33,305,766

Current Active Organizations and Grant Numbers
  1. University of Minnesota, Twin Cities
    Minneapolis, Minnesota
—HL-066845
  1. University of South Carolina
    Columbia, South Carolina
—HL-066852
  1. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina
—HL-066853
  1. Tulane University
    New Orleans, Louisiana
—HL-066855
  1. San Diego State University
    San Diego, California
—HL-066856
  1. Johns Hopkins University
    Baltimore, Maryland
—HL-066857
  1. 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 2005—$5,161,746
   Fiscal Year 2004—$837,227
Total Funding to Date—$5,998,973

Current Active Organizations and Contract Numbers
  1. New England Research Institutes, Inc.
    Watertown, Massachusetts
—HC-45207

Lung Diseases Program

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

The objective of this network is to test new therapeutic agents with a potential for improving the outcome of patients with ARDS and those at risk of developing ARDS.

Obligations

Funding History:
   Fiscal Year 2005—$4,706,675
   Fiscal Years 1994–2004—$46,208,966
Total Funding to Date—$50,915,641

Current Active Organizations and Contract Numbers
  1. Vanderbilt University
    Nashville, Tennessee
—HR-46054
  1. University of Washington
    Seattle, Washington
—HR-46055
  1. University of Michigan at Ann Arbor
    Ann Arbor, Michigan
—HR-46057
  1. University of California, San Francisco
    San Francisco, California
—HR-46059
  1. Cleveland Clinic Foundation
    Cleveland, Ohio
—HR-46060
  1. University of Colorado
    Denver, Colorado
—HR-46061
  1. LDS Hospital
    Salt Lake City, Utah
—HR-46062
  1. University of Maryland
    Baltimore, Maryland
—HR-46063
  1. Coordinating Center Massachusetts General Hospital
    Boston, Massachusetts
—HR-46064
  1. Baylor College of Medicine
    Houston, Texas
—HR-16146
  1. Baystate Medical Center
    Springfield, Massachusetts
—HR-16147
  1. University of Chicago
    Chicago, Illinois
—HR-16149
  1. Louisiana State University
    New Orleans, Louisiana
—HR-16150
  1. University of Pittsburgh
    Pittsburgh, Pennsylvania
—HR-16152
  1. University of Virginia
    Charlottesville, Virginia
—HR-16154
  1. Wake Forest University
    Winston-Salem, North Carolina
—HR-16155
  1. Baystate Medical Center
    Springfield, MA
—HR-56165
  1. University of California, San Francisco
    San Francisco, CA
—HR-56166
  1. University of Colorado Health Sciences Center
    Denver, Colorado
—HR-56167
  1. Cleveland Clinic Lerner College of Medicine-Case Western Reserve University
    Cleveland, Ohio
—HR-56168
  1. Duke University Medical Center
    Durham, North Carolina
—HR-56169
  1. John Hopkins University
    Baltimore, Maryland
—HR-56170
  1. HC Health Services, Inc.
    Salt Lake City, Utah
—HR-56171
  1. Louisiana State University
    New Orleans, Louisiana
—HR-56172
  1. University of Washington
    Seattle, Washington
—HR-56173
  1. Vanderbilt University Medical Center
    Nashville, Tennessee
—HR-56174
  1. Wake Forest University Health Sciences
    Winston-Salem, North Carolina
—HR-56175
  1. Mayo Clinic College of Medicine
    Rochester, Minnesota
—HR-56176
  1. Massachusetts General Hospital
    Boston, Massachusetts
—HR-56179

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Asthma Clinical Research Network (ACRN), 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 2005—$8,667,026
   Fiscal Years 2003–2004—$16,605,558
Total Funding to Date—$25,272,584

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

Childhood Asthma Management Program (CAMP), Initiated in Fiscal Year 1991

The purpose of this study is to evaluate the long-term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyper-responsiveness, and on physical and psychosocial growth and development. Results showed that 4 ½ to 6 years of daily treatment with inhaled corticosteroids was safe and provided superior control of asthma compared to a different anti-inflammatory medication or treatment only when symptoms occurred. The CAMP study will continue to observe the children for 5 years to determine the effect of early treatment on maximum lung growth and on height.

Obligations

Funding History:
   Fiscal Year 2005—$599,206
   Fiscal Years 1991–2004—$56,320,611
Total Funding to Date—$56,919,817

Current Active Organizations and Contract Numbers
  1. Johns Hopkins University
    Baltimore, Maryland
—HR-16044
  1. University of California, San Diego
    La Jolla, California
—HR-16045
  1. University of New Mexico
    Albuquerque, New Mexico
—HR-16046
  1. Hospital for Sick Children
    Toronto, Ontario
—HR-16047
  1. National Jewish Medical and Research Center
    Denver, Colorado
—HR-16048
  1. Brigham and Women’s Hospital
    Boston, Massachusetts
—HR-16049
  1. Asthma, Inc.
    Seattle, Washington
—HR-16050
  1. Washington University
    St. Louis, Missouri
—HR-16051
  1. Johns Hopkins University
    Baltimore, Maryland
—HR-16052

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 2005—$5,704,202
   Fiscal Years 1999–2004—$31,398,337
Total Funding to Date—$37,102,539

Current Active Organizations and Grant Numbers
  1. Washington University
    St. Louis, Missouri
—HL-064287
  1. National Jewish Medical and Research Center
    Denver, Colorado
—HL-064288
  1. University of California, San Diego
    La Jolla, California
—HL-064295
  1. University of Wisconsin
    Madison, Wisconsin
—HL-064305
  1. University of Arizona
    Tucson, Arizona
—HL-064307
  1. Pennsylvania State University
    Hershey, Pennsylvania
—HL-064313

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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 2005—$8,437,795
   Fiscal Years 2003–2004—$13,691,750
Total Funding to Date—$22,129,545

Current Active Organizations and Grant Numbers
  1. Harbor-UCLA Research and Education Institute
    Torrance, California
—HL-074407
  1. Temple University
    Philadelphia, Pennsylvania
—HL-074408
  1. Denver Health and Hospital Authority
    Denver, Colorado
—HL-074409
  1. Minnesota Veterans Research Institute
    Minneapolis, Minnesota
—HL-074416
  1. University of Alabama at Birmingham
    Birmingham, Alabama
—HL-074418
  1. University of Michigan at Ann Arbor
    Ann Arbor, Michigan
—HL-074422
  1. University of Minnesota, Twin Cities
    Minneapolis, Minnesota
—HL-074424
  1. Brigham and Women’s Hospital
    Boston, Massachusetts
—HL-074428
  1. University of California, San Francisco
    San Francisco, California
—HL-074431
  1. University of Pittsburgh
    Pittsburgh, Pennsylvania
—HL-074439
  1. University of Maryland Baltimore Professional School
    Baltimore, Maryland
—HL-074441

Feasibility of Retinoid Treatment in Emphysema (FORTE), Initiated in Fiscal Year 1999

The purpose of this program is to conduct preliminary studies to identify optimal patient populations, drugs and dosing schedules, and outcome measures before conducting a larger clinical trial on retinoid treatment for emphysema.

Obligations

Funding History:
   Fiscal Year 2005—$185,012
   Fiscal Years 1999–2004—$12,256,041
Total Funding to Date—$12,441,053

Current Active Organizations and Contract Numbers
  1. University of Minnesota, Twin Cities
    Minneapolis, Minnesota
—HR-96140
  1. Boston University
    Boston, Massachusetts
—HR-96141
  1. University of Pittsburgh
    Pittsburgh, Pennsylvania
—HR-96142
  1. University of California, Los Angeles
    Los Angeles, California
—HR-96143
  1. University of California, San Diego
    La Jolla, California
—HR-96144
  1. Columbia University
    New York, New York
—HR-96145

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 2005—$3,486,226
Total Funding to Date—$3,486,226

Current Active Organizations and Contract Numbers
  1. Mayo Clinic College of Medicine
    Rochester, Minnesota
—HL-080274
  1. Vanderbilt University
    Nashville, Tennessee
—HL-080370
  1. University of Michigan at Ann Arbor
    Ann Arbor, Michigan
—HL-080371
  1. Weill Medical College of Cornell University
    New York, New York
—HL-080383
  1. University of California, Los Angeles
    Los Angeles, California
—HL-080411
  1. Duke University
    Durham, North Carolina
—HL-080413
  1. University of Washington
    Seattle, Washington
—HL-080509
  1. Tulane University of Louisiana
    New Orleans, Louisiana
—HL-080510
  1. University of Chicago
    Chicago, Illinois
—HL-080513
  1. Emory University
    Atlanta Geogia
—HL-080543
  1. National Jewish Medical and Research Center
    Denver Colorado
—HL-080571
  1. University of California, San Francisco
    San Francisco, California
—HL-080685

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

The NETT is a multicenter trial designed to evaluate the efficacy and role of lung volume reduction surgery (a procedure in which part of the lung is removed in an attempt to improve breathing) in the treatment of severe emphysema. If surgery proves to be effective, a major secondary objective is to determine which patients are most likely to benefit.

Obligations

Funding History:
   Fiscal Year 2005—$357,270
   Fiscal Years 1997–2004—$35,846,310
Total Funding to Date—$36,203,580

Current Active Organizations and Contract Numbers
  1. Baylor College of Medicine
    Houston, Texas
—HR-76101
  1. Brigham and Women’s Hospital
    Boston, Massachusetts
—HR-76102
  1. University of California, San Diego
    La Jolla, California
—HR-76103
  1. Cedars-Sinai Medical Center
    Los Angeles, California
—HR-76104
  1. Cleveland Clinic Foundation
    Cleveland, Ohio
—HR-76105
  1. Columbia University
    New York, New York
—HR-76106
  1. Duke University Medical Center
    Durham, North Carolina
—HR-76107
  1. University of Maryland
    Baltimore, Maryland
—HR-76108
  1. Mayo Foundation
    Rochester, Minnesota
—HR-76109
  1. University of Michigan at Ann Arbor
    Ann Arbor, Michigan
—HR-76110
  1. National Jewish Medical and Research Center
    Denver, Colorado
—HR-76111
  1. The Ohio State University
    Columbus, Ohio
—HR-76112
  1. University of Pennsylvania
    Philadelphia, Pennsylvania
—HR-76113
  1. University of Pittsburgh
    Pittsburgh, Pennsylvania
—HR-76114
  1. Saint Louis University
    St. Louis, Missouri
—HR-76115
  1. Temple University
    Philadelphia, Pennsylvania
—HR-76116
  1. University of Washington
    Seattle, Washington
—HR-76118
  1. Johns Hopkins University
    Baltimore, Maryland
—HR-76119

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 2005—$6,459,743
   Fiscal Years 2001–2004—$23,181,808
Total Funding to Date—$29,641,551

Current Active Organizations and Grant Numbers
  1. University of Nebraska Medical Center
    Omaha, Nebraska
—HL-069233
  1. Fred Hutchinson Cancer Research Center
    Seattle, Washington
—HL-069246
  1. Dana Farber Cancer Institute
    Boston, Massachusetts
—HL-069249
  1. Children’s Mercy Hospital
    Kansas City, Missouri
—HL-069254
  1. University of California, San Diego
    La Jolla, California
—HL-069273
  1. CDuke University
    Durham, North Carolina
—HL-069274
  1. City of Hope Medical Center
    Duarte, California
—HL-069278
  1. University of Pennsylvania
    Philadelphia, Pennsylvania
—HL-069286
  1. University of Minnesota, Twin Cities
    Minneapolis, Minnesota
—HL-069290
  1. Stanford University
    Stanford, California
—HL-069291
  1. Medical College of Wisconsin
    Milwaukee, Wisconsin
—HL-069294
  1. University of Florida
    Gainesville, Florida
—HL-069301
  1. Johns Hopkins University
    Baltimore, Maryland
—HL-069310
  1. Sloan Kettering Institute for Cancer Research
    New York, New York
—HL-069315
  1. University of Michigan at Ann Arbor
    Ann Arbor, Michigan
—HL-069330
  1. Case Western Reserve University
    Cleveland, Ohio
—HL-069348

Cord Blood Stem Cell Transplantation Study (COBLT), Initiated in Fiscal Year 1996

The purpose of this multicenter study is to determine whether umbilical cord blood stem cell transplants from unrelated, newborn donors are a safe and efficient alternative to bone marrow transplantation for children and adults with a variety of cancers, blood diseases, and genetic disorders.

Obligations

Funding History:
   Fiscal Year 2005—$822,243
   Fiscal Years 1996–2004—$32,406,365
Total Funding to Date—$33,228,608

Current Active Organizations and Contract Numbers
  1. The EMMES Corporation
    Potomac, Maryland
—HB-67132
  1. Dana-Farber Cancer Institute
    Boston, Massachusetts
—HB-67133
  1. Fred Hutchinson Cancer Research Center
    Seattle, Washington
—HB-67134
  1. University of California, Los Angeles
    Los Angeles, California
—HB-67135
  1. Indiana University
    Indianapolis, Indiana
—HB-67137
  1. Duke University Medical Center
    Durham, North Carolina
—HB-67138
  1. University of Minnesota, Twin Cities
    Minneapolis, Minnesota
—HB-67139
  1. Duke University Medical Center
    Durham, North Carolina
—HB-67141
  1. University of California, Los Angeles
    Los Angeles, California
—HB-67142

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Multicenter Study of Hydroxyurea (MSH) in Sickle Cell Anemia Adult Follow-up, Initiated in Fiscal Year 1996

The purpose of this trial is to determine the long-term effects of hydroxurea. Patients were examined annually to determine their health status, quality of life, incidence of malignancies, and birth defects in their offspring(s). Mortality rates from this cohort were compared to mortality data from the CSSCD cohort and the normal black population mortality. Results showed that patients who took hydroxyurea over a 9-year period experienced a 40 percent reduction in deaths. Improved survival was related to benefits of drug therapy—an increase in fetal hemoglobin level and reduced episodes of severe pain “crises” and acute chest syndrome.

Obligations

Funding History:
   Fiscal Year 2005—$1,340,090
   Fiscal Years 1996–2004—$4,836,836
Total Funding to Date—$6,176,926

Current Active Organization and Contract Number
  1. Maryland Medical Research Institute
    Baltimore, Maryland
—HB-67129

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 2005—$1,526,201
   Fiscal Years 2000–2004—$8,187,198
Total Funding to Date—$9,713,399

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

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 2005—$2,729,989
   Fiscal Years 2000–2004—$11,374,688
Total Funding to Date—$14,104,677

Current Active Organizations and Grant Numbers
  1. Children’s Hospital of Philadelphia
    Philadelphia, Pennsylvania
—HL-065232
  1. Hospital for Sick Children
    Toronto, Ontario
—HL-065233
  1. New England Research Institute, Inc.
    Watertown, Massachusetts
—HL-065238
  1. Children’s Hospital Oakland
    Oakland, California
—HL-065239
  1. Weill Medical College of Cornell University
    New York, New York
—HL-065244
  1. 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 throm-bocytopenia and thrombotic thrombocytopenic purpura, and to evaluate new and existing blood products and cytokines for treatment of hematologic disorders.

Obligations

Funding History:
   Fiscal Year 2005—$6,221,140
   Fiscal Years 2002–2004—$18,386,476
Total Funding to Date—$24,607,616

Current Active Organizations and Grant Numbers
  1. University of Iowa
    Iowa City, Iowa
—HL-072028
  1. Case Western Reserve University
    Cleveland, Ohio
—HL-072033
  1. University of Minnesota, Twin Cities
    Minneapolis, Minnesota
—HL-072072
  1. Johns Hopkins University
    Baltimore, Maryland
—HL-072191
  1. Weill Medical College of Cornell University
    New York, New York
—HL-072196
  1. Emory University
    Atlanta, Georgia
—HL-072248
  1. New England Research Institutes, Inc.
    Watertown, Massachusetts
—HL-072268
  1. Tulane University of Louisiana
    New Orleans, Louisiana
—HL-072274
  1. University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma
—HL-072283
  1. Duke University
    Durham, North Carolina
—HL-072289
  1. Blood Center of Southeastern Wisconsin
    Milwaukee, Wisconsin
—HL-072290
  1. Children’s Hospital
    Boston, Massachusetts
—HL-072291
  1. Massachusetts General Hospital
    Boston, Massachusetts
—HL-072299
  1. Puget Sound Blood Center
    Seattle, Washington
—HL-072305
  1. University of Pittsburgh
    Pittsburgh, Pennsylvania
—HL-072331
  1. University of Pennsylvania
    Philadelphia, Pennsylvania
—HR-76116
  1. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina
—HL-072355
  1. University of Maryland Baltimore Professional School
    Baltimore, Maryland
—HL-072359

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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.

Obligations

Funding History:
   Fiscal Year 2005—$37,826,017
   Fiscal Years 2000–2004*—$672,615,477
Total Funding to Date—$710,441,494

Current Active Organizations and Contract Numbers
  1. Fred Hutchinson Cancer Research Center
    Seattle, Washington
—WH-22110
  1. University of Medicine and Dentistry of New Jersey
    Newark, New Jersey
—WH-24152
  1. Fred Hutchinson Cancer Research Center
    Seattle, Washington
—WH-32100
  1. University of Minnesota, Twin Cities
    Minneapolis, Minnesota
—WH-32101
  1. University of Iowa College of Medicine
    Iowa City, Iowa
—WH-32102
  1. University of Alabama at Birmingham
    Birmingham, Alabama
—WH-32105
  1. Wake Forest University
    Winston-Salem, North Carolina
—WH-32106
  1. Northwestern University
    Chicago, Illinois
—WH-32108
  1. Brigham and Women’s Hospital
    Boston, Massachusetts
—WH-32109
  1. University of Medicine and Dentistry of New Jersey
    Newark, New Jersey
—WH-32110
  1. Emory University
    Atlanta, Georgia
—WH-32111
  1. University of Pittsburgh
    Pittsburgh, Pennsylvania
—WH-32112
  1. University of California, Davis
    Davis, California
—WH-32113
  1. University of Arizona
    Tucson, Arizona
—WH-32115
  1. University of Tennessee
    Memphis, Tennessee
—WH-32118
  1. Memorial Hospital of Rhode Island
    Pawtucket, Rhode Island
—WH-32119
  1. University of California, San Diego
    La Jolla, California
—WH-32120
  1. State University of New York at Buffalo
    Buffalo, New York
—WH-32122
  1. American College of Obstetriciansand Gynecologists
    Washington, DC
—WH-34205
  1. University of California, Irvine
    Irvine, California
—WH-42107
  1. George Washington University
    Washington, DC
—WH-42108
  1. Stanford University
    Stanford, California
—WH-42109
  1. Baylor College of Medicine
    Houston, Texas
—WH-42110
  1. University of Texas Health Science Center
    San Antonio, Texas
—WH-42111
  1. Ohio State University
    Columbus, Ohio
—WH-42112
  1. University of Nevada School of Medicine
    Reno, Nevada
—WH-42113
  1. Kaiser Foundation Research Institute
    Oakland, California
—WH-42114
  1. State University of New York at Stony Brook
    Stony Brook, New York
—WH-42115
  1. University of Massachusetts Medical School
    Worcester, Massachusetts
—WH-42116
  1. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina
—WH-42117
  1. Wayne State University
    Detroit, Michigan
—WH-42118
  1. Albert Einstein College of Medicine
    New York, New York
—WH-42119
  1. Harbor-UCLA Research and Education Institute
    Torrance, California
—WH-42120
  1. Kaiser Foundation Research Institute
    Oakland, California
—WH-42121
  1. Medical College of Wisconsin
    Milwaukee, Wisconsin
—WH-42122
  1. Medlantic Research Institute
    Washington, DC
—WH-42123
  1. Rush-Presbyterian-St. Luke’s Medical Center
    Chicago, Illinois
—WH-42124
  1. University of California, Los Angeles School of Medicine
    Los Angeles, California
—WH-42125
  1. University of Cincinnati Medical Center
    Cincinnati, Ohio
—WH-42126
  1. University of Florida College of Medicine
    Gainesville, Florida
—WH-42129
  1. University of Hawaii at Manoa
    Honolulu, Hawaii
—WH-42130
  1. University of Miami
    Miami, Florida
—WH-42131
  1. University of Wisconsin
    Madison, Wisconsin
—WH-42132

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