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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 1996–2006

  Research Grants and Cooperative Agreements (Dollars in Thousands)
  Fiscal Year
  1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Heart and Vascular Diseases                      
Program on Surgical Control of Hyperlipidemias (POSCH)
$566 $294 $— $— $— $— $— $— $— $— $—
Emory Angioplasty Versus Surgery Trial (EAST)
296
Asymptomatic Carotid Artery Plaque Study (ACAPS)
70
Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest
699 685 582 584 392 75
Multicenter Unsustained Tachycardia Trial*
504
Women’s Health Study (WHS)
1,434 1,473 1,536 1,530 1,594 889
Cardiovascular Risk Factors and the Menopause
478 494 528 186
CABG Patch Trial*
988 1,171
Women’s Antioxidant and Cardiovascular Study (WACS)
643 501 525 540 556 572 598 592 599 670
Oral Calcium in Pregnant Women With Hypertension
320 332
Stress Reduction and Atherosclerotic CVD in Blacks
403 407 40 326 339 360 376 394
Enalapril After Anthracycline Cardiotoxicity
707 724 789
Stress and Anger Management for Blacks With Hypertension
241 250
Estrogen Replacement and Atherosclerosis (ERA) Trial*
1,213 965 1,668 1,017
Shock Trial: Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock?
1,008 826 874 440 362 298 291 296
HDL-Atherosclerosis Treatment Study
427 445 340 326
Influence of Cardiopulmonary Bypass (CPB) Temperature on CABG Morbidity
118
Women’s Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)*
508 1,196 1,269 1,131 32
Mode Selection Trial in Sinus Node Dysfunction (MOST)*
1,857 2,096 1,700 2,879 1,136 154
Antioxidants and Prevention of Early Atherosclerosis*
240 603
Postmenopausal Hormone Therapy in Unstable Angina
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 1,963 963
Bypass Angioplasty Revascularization Investigation in Type 2 Diabetics (BARI 2D)*
3,942 6,515 9,342 8,189 8,265 8,304 8,592
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
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 4,590
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
Surgical Treatment for Ischemic Heart Failure (STICH)*
5,709 4,495 1,613 6,082 5,583
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
Weight Loss Maintenance (WLM)*
3,687 4,368 3,099 4,015
Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)*
4,343 5,610 4,884
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 10,966
AIM HIGH: Niacin Plus Statin To Prevent Vascular Events*
663 6,324
Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)*
1,368 1,478
Intervention To Control Obesity in College
677
PACEmaker and Beta-Blocker Therapy Post-Myocardial Infarction (PACE-MI)
1,300
Subtotal, Heart and Vascular Diseases 13,673 19,483 23,265 29,111 26,578 22,996 45,253 50,163 52,377 56,681 58,312
Lung Diseases                      
Inhaled Beclomethasone To Prevent Chronic Lung Disease*
551 436
Lung Health Study II*
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 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 Asthm
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 2,750
Clinical Trial of Acid Reflux Therapy in Asthma*
736 783 791 773
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 4,390 1,004
Supplemental Selenium and Vitamin E and Pulmonary Function
698 610 630 605
Improving Asthma Care in Minority Children in Head Start
721 826 1,004
Adenotonsillectomy for Childhood Sleep Apnea
2,255
Subtotal, Lung Diseases 3,734 3,944 7,911 8,844 15,484 17,076 18,974 15,639 14,289 10,056 9,294
Blood Diseases and Resources                      
Trial To Reduce Alloimmunization to Platelets (TRAP)—Extension
263
Stroke Prevention in Sickle Cell Anemia (STOP)*
2,435 2,584 2,036 293
Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG)
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 2,446
Stroke With Transfusions Changing to Hydroxyurea (SWITCH)*
3,345 3,932
Subtotal, Blood Diseases and Resources 2,958 2,854 2,036 4,493 4,877 4,917 5,772 6,066 6,268 6,378
Total, NHLBI $20,365 $26,281 $33,212 $37,955 $46,555 $44,949 $69,144 $71,574 $82,220 $73,005 $73,984

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

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NHLBI Investigator-Initiated Phase III Clinical Trials, Fiscal Year 2006: Summary by Program

  Total Obligations Prior to FY 2006 FY 2006 Obligations Total Obligations to Date
Heart and Vascular Diseases      
AIM HIGH: Niacin Plus Statin To Prevent Vascular Events*
$663,376 $6,323,911 $6,987,287
Bypass Angioplasty Revascularization Investigation in Type 2 Diabetics (BARI 2D)*
44,558,208 8,591,820 53,150,028
Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)*
9,953,424 4,884,074 14,837,498
Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)
1,368,413 1,478,581 2,846,994
Clinical Trial of Dietary Protein on Blood Pressure
2,381,223 500,047 2,881,270
FREEDOM Trial: Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease
8,332,457 8,332,457
Girls Health Enrichment Multisite Studies*
7,230,952 1,950,186 9,181,138
Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training*
29,509,092 4,590,429 34,099,521
Heart Failure Adherence and Retention Trial (HART)
5,900,058 739,763 6,639,821
Home Automatic External Defibrillator Trial (HAT)*
15,064,384 2,114,588 17,178,972
IMMEDIATE Trial: Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care*
14,684,147 10,966,492 25,650,639
Interventions to Control Obesity in College
667,082 667,082
Occluded Artery Trial (OAT)
16,261,456 963,058 17,224,514
PACEmaker and Beta-Blocker Therapy Post-Myocardial Infarction (PACE-MI)
1,300,000 1,300,000
Perioperative Interventional Neuroprotection Trial (POINT)
2,240,021 377,720 2,617,741
Reduction of Triglycerides in Women on HRT
3,275,109 3,275,109
Stop Atherosclerosis in Native Diabetics Study (SANDS)*
9,004,979 2,074,057 11,079,036
Surgical Treatment for Ischemic Heart Failure (STICH)*
17,899,276 5,583,045 23,482,321
Treatment of Depression Following Bypass Surgery
3,276,909 1,192,794 4,469,703
Weight Loss Maintenance (WLM)*
11,153,382 4,014,660 15,168,042
Women’s Health Study (WHS)
16,922,647 16,922,647
Women’s Ischemia Syndrome Evaluation (WISE)*
6,613,113 6,613,113
Subtotal, Heart and Vascular Diseases 226,292,626 58,312,307 284,604,933
Lung Diseases      
Acid Reflux Therapy in Asthma*
2,310,686 772,866 3,083,552
Adentonsillectomy for Childhood Sleep Apnea*
2,254,440 2,254,440
APPLES: Apnea Positive Pressure Long-Term Efficacy Study*
12,542,181 12,542,181
Childhood Asthma Management Program II (CAMP II)*
6,155,523 2,750,045 8,905,568
Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)
1,902,104 694,178 2,596,282
Improving Asthma Care for Minority Children in Head Start
1,547,135 1,004,355 2,551,490
Outcomes of Sleep Disorders in Older Men
9,814,166 1,142,218 10,956,384
Scleroderma Lung Study
6,857,221 71,079 6,928,300
Supplemental Selenium and Vitamin E and Pulmonary Function
1,938,311 604,383 2,542,694
Subtotal, Lung Diseases 43,067,327 9,293,564 52,360,891
Blood Diseases and Resources      
FOCUS*
6,357,932 2,446,287 8,804,219
Stroke With Transfusions Changing to Hydroxyurea (SWITCH)*
3,345,345 3,931,995 7,277,340
Subtotal, Blood Diseases and Resources 9,703,277 6,378,282 16,081,559
Total, NHLBI $255,944,553 $73,984,153 $329,928,706

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

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Institute-Initiated Clinical Trials: Fiscal Years 1996–2006

Contracts

  Dollars (Thousands)
  Fiscal Year
  1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Heart and Vascular Diseases                      
Lipid Research Clinics
$660 $650 $685 $— $— $— $— $— $— $— $—
Raynaud’s Treatment Study
221 19
Antiarrhythmic vs. Implantable Defibrillator (AVID)
2,475 871 548
Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT)
9,676 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)
6,993 6,837 5,904 3,303 3,487 596 425 70
Atrial Fibrillation Follow-Up: Investigation in Rhythm Management (AFFIRM)
2,510 6,330 3,785 1,239 2,401 802
Beta-Blocker Evaluation Survival Trial (BEST)
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 1,129 311
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)
837 5,162 5,480
Subtotal, Heart and Vascular Diseases 29,910 40,111 38,490 26,032 31,350 13,821 12,324 21,942 37,962 31,288 5,791
Lung Diseases                      
Lung Health Study I
350
Pediatric Pulmonary and Cardiac Complications of HIV Infection (P2C2)
4,033 668 1,979 315 113
Childhood Asthma Management Program (CAMP)
7,977 5,695 6,551 729 1,330 2,786 2,287 1,475 599
Acute Respiratory Distress Syndrome Clinical Network (ARDSNET)
4,337 4,510 4,880 6,837 5,587 2,667 1,502 4,402 5,517 4,707 7,396
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 16,697 13,583 10,226 21,817 18,389 10,986 14,740 9,044 9,147 5,848 7,396
Blood Diseases and Resources                      
Clinical Course of Sickle Cell Disease
376 205 2,144 350 106
Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission
706
T-Cell Depletion in Unrelated Donor Marrow Transplantation
1,461 639 2,228 690 1,085 1,144 557 774 164
Viral Activation Transfusion Study (VATS)
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 1,526 891
Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension
1,867
Subtotal, Blood Diseases and Resources 10,312 10,242 19,045 2,965 8,258 3,395 6,411 3,468 3,971 3,688 2,758
Women’s Health Initiative                      
Subtotal, Women’s Health Initiative 59,100 57,700 59,200 59,010 63,222 57,483 37,826 12,124
Total, NHLBI Clinical Trials Contracts $56,919 $63,936 $67,761 $109,914 $115,697 $87,402 $92,485 $97,676 $108,563 $78,650 $28,069


Cooperative Agreements

                     
Heart and Vascular Diseases                      
Trials of Hypertension Prevention (TOHP)
$649 $— $— $— $— $— $— $— $— $— $—
Dietary Intervention Study in Children (DISC)
1,625 746
Bypass Angioplasty Revascularization Investigation (BARI)
2,757 2,894 1,360 1,609 1,634 1,549 1,456
Postmenopausal Estrogen/Progestin Interventions (PEPI)
331
Child and Adolescent Trial for Cardiovascular Health (CATCH)
2,682 3,956 572 210
Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA)
132 290
Obesity Prevention in Young American Indians (PATHWAYS)
3,432 4,119 3,945 4,196 2,459
Dietary Approaches To Stop Hypertension (DASH)
899
Rapid Early Action for Coronary Treatment (REACT)
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 5,103 905
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 9,728
Dynamic Assessment of Patient-Reported Chronic Disease Outcomes
1,010
Clinical Trials in Organ Transplantation (CTOT)
1,900 1,855
Pediatric Heart Network
  6,988
Heart Failure Clinical Research Network
5,642
Weight Loss in Obese Adults With CVD Risk Factors
2,567
NICHD Cooperative Multicenter Neonatal Research Network
1,336
Pediatric HIV/AIDS Cohort Study (PHACS)—Data and Operations Center
1,000
Subtotal, Heart and Vascular Diseases 17,499 14,871 6,373 8,297 11,732 12,704 14,910 11,209 19,194 20,334 30,021
Lung Diseases                      
Asthma Clinical Research Network (ACRN)*
4,526 4,479 8,181 8,424 8,667 7,839
Asthma and Pregnancy Studies
1,000 913
Childhood Asthma Research and Education (CARE) Network
4,175 5,002 5,314 6,005 5,610 5,292 5,704 5,735
COPD Clinical Research Network
6,843 6,848 8,438 7,664
Idiopathic Pulmonary Fibrosis Clinical Research Network
3,486 7,349
Subtotal, Lung Diseases 5,526 5,392 4,175 5,002 5,314 6,005 20,634 20,564 26,295 28,587
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
Blood and Marrow Transplant Clinical Research Network
5,360 5,899 5,950 5,292 6,460 6,845
Transfusion Medicine/ Hemostasis Clinical Research Network
6,053 6,241 6,093 6,221 6,521
Sickle Cell Disease Clinical Research Network
3,761
Subtotal, Blood Diseases and Resources 2,192 7,579 14,221 14,511 14,440 15,411 19,809
Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements $23,025 $20,263 $6,373 $12,472 $18,926 $25,597 $35,136 $46,354 $54,198 $62,040 $78,417
Total, NHLBI-Initiated Clinical Trials $79,944 $84,199 $74,134 $122,386 $134,623 $112,999 $127,621 $144,030 $162,761 $140,690 $106,486

* Investigator-Initiated From 1998 to 2002.

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Institute-Initiated Clinical Trials, Fiscal Year 2006: Summary by Program

Contracts

  Total Obligations Prior to FY 2006 Total FY 2006 Obligations Total Obligations to Date
Heart and Vascular Diseases      
Action To Control Cardiovascular Risk in Diabetes (ACCORD)
$90,895,802 $— $90,895,802
Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE)
4,699,537 311,000 5,010,537
Trial of Aldosterone Antagonists Therapy in Adults With Ejection Fraction Congestive Heart Failure (TOPCAT)
5,998,973 5,479,690 11,478,663
Subtotal, Heart and Vascular Diseases 101,594,312 5,790,690 107,385,002
Lung Diseases      
Acute Respiratory Distress Syndrome Clinical Network (ARDSNET)
50,915,641 7,396,064 58,311,705
Subtotal, Lung Diseases 50,915,641 7,396,064 58,311,705
Blood Diseases and Resources      
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
9,713,399 891,000 10,604,399
Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension
1,867,000 1,867,000
Subtotal, Blood Diseases and Resources 9,713,399 2,758,000 12,471,399
Women’s Health Initiative      
Subtotal, Women’s Health Initiative 710,441,494 12,124,061 722,565,555
Total, NHLBI-Initiated Clinical Trials, Contracts $872,664,846 $28,068,815 $900,733,661

Cooperative Agreements

  Total Obligations Prior to FY 2006 Total FY 2006 Obligations Total Obligations to Date
Heart and Vascular Diseases      
Clinical Research Consortium To Improve Resuscitation Outcome
$16,224,715 $9,728,012 $25,952,727
Clinical Trials in Organ Transplantation (CTOT)
1,900,000 1,855,350 3,755,350
Dynamic Assessment of Patient-Reported Chronic Disease Outcomes
1,009,694 1,009,694
Heart Failure Clinical Research Network
5,642,461 5,642,461
NICHD Cooperative Multicenter Neonatal Research Network
1,336,159 1,336,159
Pediatric Heart Network
6,988,223 6,988,223
PHACS—Data and Operations Center
1,000,000 1,000,000
Trial of Activity for Adolescent Girls (TAAG)
33,305,766 905,336 34,211,102
Weight Loss in Obese Adults With CVD Risk Factors
2,567,146 2,567,146
Subtotal, Heart and Vascular Diseases 52,440,175 30,022,687 82,462,862
Lung Diseases      
Asthma Clinical Research Network (ACRN), Phase II
25,272,584 7,838,310 33,110,894
Childhood Asthma Research and Education (CARE) Network
37,102,539 5,734,754 42,837,293
COPD Clinical Research Network
22,129,545 7,664,383 29,793,928
Idiopathic Pulmonary Fibrosis Clinical Research Network
3,486,226 7,349,196 10,835,422
Subtotal, Lung Diseases 87,990,894 28,586,643 116,577,537
Blood Diseases and Resources      
Blood and Marrow Transplant Clinical Research Network
29,641,551 6,845,170 36,486,721
Sickle Cell Disease Clinical Research Network
3,761,385 3,761,385
Thalassemia (Cooley’s Anemia) Clinical Research Network
14,104,677 2,682,493 16,787,170
Transfusion Medicine/Hemostasis Clinical Research Network
24,607,616 6,520,638 31,128,254
Subtotal, Blood Diseases and Resources 68,353,844 19,809,686 88,163,530
Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements $208,784,913 $78,419,016 $287,203,929
Total, NHLBI-Initiated Clinical Trials $1,087,626,685 $106,487,831 $1,194,114,516

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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 2006—$0
   Fiscal Years 1999–2005—$90,895,802
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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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 cardiopul-monary 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 2006—$9,728,012
   Fiscal Year 2004–2005—$16,224,715
Total Funding to Date—$25,952,727

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 2006—$1,855,350
   Fiscal Year 2005—$1,900,000
Total Funding to Date—$3,755,350

Current Active Organizations and Contract Numbers
  1. University of Pennsylvania
    Philadelphia, Pennsylvania
—AI-063589
  1. Mount Sinai School of Medicine
    New York, New York
—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 2006—$0
   Fiscal Year 2004–2005—$1,009,694
Total Funding to Date—$1,009,694

Current Active Organizations and Grant Numbers
  1. University of Pittsburgh
    Pittsburgh, Pennsylvania
—AR-052155
  1. Stanford University
    Stanford, California
—AR-052158
  1. State University New York, Stony Brook
    Stony Brook, New York
—AR-052170
  1. University of Washington
    Seattle, Washington
—AR-052171
  1. Evanston Northwestern Healthcare
    Evanston, Illinois
—AR-052177
  1. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina
—AR-052181
  1. Duke University
    Durham, North Carolina
—AR-52186

Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), Initiated in Fiscal Year 1999

The purpose of this study is to compare the efficacy of pulmonary artery catheterization-directed (PAC) treatment strategy to a noninvasive treatment strategy on morbidity and mortality in patients with severe congestive heart failure. Forty-two percent of the participants are black. Results of the trial presented in November 2004 showed that PAC did not increase or decrease death or the number of days hospitalized in patients with severe heart failure. Follow-up studies are comparing the quality of life, ability to exercise, and changes in the heart’s structure and function as measured by echocardiograms between the groups.

Obligations

Funding History:
   Fiscal Year 2006—$311,000
   Fiscal Year 1999–2005—$4,699,537
Total Funding to Date—$5,010,537

Current Active Organizations and Grant Numbers
  1. Duke University
    Durham, North Carolina
—HV-98177

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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 2006—$5,642,461
Total Funding to Date—$5,642,461

Current Active Organizations and Grant Numbers
  1. Minneapolis Medical Research Foundation, Inc.
    Minneapolis, Minnesota
—HL-084861
  1. Duke University
    Durham, North Carolina
—HL-084875
  1. Brigham and Women’s Hospital
    Boston, Massachusetts
—HL-084877
  1. University of Utah
    Salt Lake City, Utah
—HL-084889
  1. Baylor College of Medicine
    Houston, Texas
—HL-084890
  1. University of Vermont and State Agriculture College
    Burlington, Vermont
—HL-084899
  1. Duke University
    Durham, North Carolina
—HL-084904
  1. Mayo Clinic College of Medicine
    Rochester, Minnesota
—HL-084907
  1. Montreal Heart Institute
    Montreal Quebec, Canada
—HL-084931

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 2006—$1,336,159
Total Funding to Date—$1,336,159

Current Active Organizations and Grant Numbers
  1. Case Western Reserve University
    Cleveland, Ohio
—HD-021364
  1. University of Texas Health Science Center
    Houston, Texas
—HD-021373
  1. Wayne State University
    Detroit, Michigan
—HD-021385
  1. Emory University
    Atlanta, Georgia
—HD-027851
  1. Children’s Hospital Medical Center
    Cincinnati, Ohio
—HD-027853
  1. Indiana University-Purdue University at Indianapolis
    Indianapolis, Indiana
—HD-027856
  1. Yale University
    New Haven, Connecticut
—HD-027871
  1. Stanford University
    Stanford, California
—HD-027880
  1. Women and Infants Hospital
    Providence, Rhode Island
—HD-027904
  1. University of Alabama at Birmingham
    Birmingham, Alabama
—HD-034216
  1. Duke University
    Durham, North Carolina
—HD-040492
  1. University of Texas Southwestern Medical Center
    Dallas, Texas
—HD-040689
  1. University of New Mexico
    Albuquerque, New Mexico
—HD-053089
  1. University of Iowa
    Iowa City, Iowa
—HD-053109
  1. New England Medical Center Hospitals
    Boston, Massachusetts
—HD-053119
  1. University of Utah
    Salt Lake City, Utah
—HD-053124

Pediatric Heart Network, Initiated in Fiscal Year 2006

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 2006—$6,988,223
Total Funding to Date—$6,988,223

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
  1. Children’s Hospital Medical Center
    Cincinnati, Ohio
—HL-085057

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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 preg-nancy and in newborns.

Obligations

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

Current Active Organizations and Grant Numbers
  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 2006—$905,336
   Fiscal Years 2000–2005—$33,305,766
Total Funding to Date—$34,211,102

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 2006—$5,479,690
   Fiscal Year 2004–2005—$5,998,973
Total Funding to Date—$11,478,663

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

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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.

Obligations

Funding History:
   Fiscal Year 2006—$2,567,146
Total Funding to Date—$2,567,146

Current Active Organizations and Grant Numbers
  1. Brigham and Women’s Hospital
    Boston, Massachusetts
—HL-087071
  1. University of Pennsylvania
    Philadelphia, Pennsylvania
—HL-087072
  1. Johns Hopkins University
    Baltimore, Maryland
—HL-087085

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 2006—$7,396,064
   Fiscal Years 1994–2005—$50,915,641
Total Funding to Date—$58,311,705

Current Active Organizations and Contract Numbers
  1. Baystate Medical Center
    Springfield, Massachusetts
—HR-56165
  1. University of California, San Francisco
    San Francisco, California
—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

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 2006—$7,838,310
   Fiscal Years 2003–2005—$25,272,584
Total Funding to Date—$33,110,894

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
    University of Texas Medical Branch
—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

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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 2006—$5,734,754
   Fiscal Years 1999–2005—$37,102,539
Total Funding to Date—$42,837,293

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

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 2006—$7,664,383
   Fiscal Years 2003–2005—$22,129,545
Total Funding to Date—$29,793,928

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

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 2006—$7,349,196
   Fiscal Year 2005—$3,486,226
Total Funding to Date—$10,835,422

Current Active Organizations and Grant 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

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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 2006—$6,845,170
   Fiscal Years 2001–2005—$29,641,551
Total Funding to Date—$36,486,721

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. Duke 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, Floridas
—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

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 2006—$891,000
   Fiscal Years 2000–2005—$9,713,399
Total Funding to Date—$10,604,399

Current Active Organizations and Contract 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

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 2006—$3,761,385
Total Funding to Date—$3,761,385

Current Active Organizations and Contract Numbers
  1. Duke University
    Durham, North Carolina
—HL-083698
  1. Emory University
    Atlanta, Georgia
—HL-083699
  1. Children’s Hospital and Research Center
    Oakland, California
—HL-083704
  1. Drexel University
    Philadelphia, Pennsylvania
—HL-083705
  1. New England Research Institutes, Inc.
    Watertown, Massachusetts
—HL-083721
  1. University of Illinois at Chicago
    Chicago, Illinois
—HL-083730
  1. Virginia Commonwealth University
    Richmond, Virginia
—HL-083732
  1. Children’s Hospital of Philadelphia
    Philadelphia, Pennsylvania
—HL-083746
  1. Howard University
    Washington, DC
—HL-083748
  1. Boston Medical Center
    Boston, Massachusetts
—HL-083771

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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 2006—$1,867,000
Total Funding to Date—$1,867,000

Current Active Organizations and Contract Numbers
  1. Rho Federal Systems Division, Inc.
    Chapel Hill, North Carolina
—HB-67182
  1. Imperial College of London
    London, England
—HB-67183
  1. Children’s Hospital of Pittsburgh
    Pittsburgh, Pennsylvania
—HB-67184
  1. University of Colorado
    Denver, Colorado
—HB-67185
  1. Children’s Hospital and Research Center at Oakland
    Oakland, California
—HB-67186
  1. University of Illinois at Chicago
    Chicago, Illinois
—HB-67187
  1. Johns Hopkins University
    Baltimore, Maryland
—HB-67188
  1. Howard University
    Washington, DC
—HB-67189
  1. 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 2006—$2,682,493
   Fiscal Years 2000–2005—$14,104,677
Total Funding to Date—$16,787,170

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 and Research Center at 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 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 2006—$6,520,638
   Fiscal Years 2002–2005—$24,607,616
Total Funding to Date—$31,128,254

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
—HL-072346
  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 2006—$12,124,061
   Fiscal Years 2000–2005*—$710,441,494
Total Funding to Date—$722,565,555

* 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 interagency 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
  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 Obstetricians and 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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