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 2001–2011

Research Grants and Cooperative Agreements (Dollars in Thousands)

 

FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011
Heart and Vascular Diseases

 

 

 

 

 

 

 

 

 

 

 

Infant Heart Surgery:  Central Nervous System Sequelae of Circulatory Arrest $  75 $  — $  — $  — $  — $  —  $  — $  — $  — $  — $  —
Women’s Health Study (WHS) 889 868 875 919 927
Women’s Antioxidant and Cardiovascular Study (WACS) 572 598 592 599 670
Stress Reduction and Atherosclerotic CVD in Blacks 360 376 394
Shock Trial:  Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock? 362 298 291 296
Women’s Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)* 32
Mode Selection Trial in Sinus Node Dysfunction (MOST)* 154
Estrogen and Graft Atherosclerosis Research Trial (EAGER)* 371
REMATCH Trial* 750
Dietary Patterns, Sodium Intake, and Blood Pressure (DASH Sodium)* ** 151 387 376 395
Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)* 1,798 1,412 1,930
CVD Risk and Health in Post-Menopausal Phytoestrogen Users 304 152
Treatment of Hypertension With Two Exercise Intensities 420
Prevention of Recurrent Venous Thromboembolism (PREVENT) 543 1,272
PREMIER:  Lifestyle Interventions for Blood Pressure Control* 2,925 1,505
Azithromycin and Coronary Events Study (ACES)* 720 1,254 1,137
Antiarrhythmic Effects of N-3 Fatty Acids 529 647
Occluded Artery Trial (OAT)* 2,604 1,724 1,963 963 1,452 1,277 1,270 1,033
Bypass Angioplasty Revascularization Investigation in Type 2 Diabetics (BARI 2D)* 6,515 9,342 8,189 8,265 8,304 8,592 2,647 1,971 1,130
Hematocrit Strategy in Infant Heart Surgery* 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 1,174 862 740 304
Reduction of Triglycerides in Women on HRT 708 746 555 544 721 625 501
Women’s Ischemia Syndrome Evaluation (WISE)* ** 1,502 1,506 1,306 1,303 996
ACE Inhibition and Novel Cardiovascular Risk Factors 694 656 602
Heart Failure:  A Controlled Trial Investigating  Outcomes of Exercise (HF-ACTION)* 7,471 9,582 7,973 4,483 4,590 2,846 652
Clinical Trial of Dietary Protein on Blood Pressure 655 610 612 504 500
Home Automatic External Defibrillator Trial (HAT)* 3,567 5,433 4,264 1,801 2,115
Perioperative Interventional Neuroprotection Trial (POINT) 553 553 562 572 378
Stop Atherosclerosis in Native Diabetics Study (SANDS)* 2,410 2,165 2,107 2,324 2,074 197 218
Surgical Treatment for Ischemic Heart Failure (STICH)* 5,709 6,542 1,613 6,082 5,583 9,396 3,639 727 1,233 352
Girls Health Enrichment Multisite Studies (GEMS)* 2,461 2,400 2,369 1,950
Treatment of Depression Following Bypass Surgery 964 1,132 1,181 1,193 885
Weight Loss Maintenance (WLM)* 3,687 4,368 3,099 4,015 2,151 145 150
Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)* 4,343 5,610 4,884 3,307 3,269 4,414 3,029
FREEDOM Trial:  Future Revascularization Evaluation in Patients With Diabetes Mellitus:  Optional Management of Multivessel Disease 3,663 4,669 5,180 2,818 1,658 3,429 2,755
IMMEDIATE Trial:  Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care* 5,170 9,514 10,966
AIM HIGH:  Niacin Plus Statin To Prevent Vascular Events* 663 6,324 6,018 1,380 2,324 6,927 1,089
Claudication:  Exercise Versus Endoluminal Revascularization (CLEVER)* 1,368 1,478 1,898 1,822 1,080 1,371
Interventions To Control Obesity in College 677 633 670 686 588
PACEmaker and Beta-Blocker Therapy Post-Myocardial Infarction (PACE-MI) 1,300 4,555 384
Efficacy of Smoking Quit Line in the Military 739 720 731 723
Vest prevention of Early Sudden Death Trial (VEST) and PREDiction of ICd Therapies Studies (PREDICTS)* 1,390 1,356 1,391 1,404
Randomized Trial of Interventions To Improve Warfarin Adherence 801 787 771 763
Planned Care for Obesity and Risk Reduction (Planned CORR) 784 770 769 768
Effects of Niacin on Lp(a), Oxidized LDL, and Inflammation on the AIM-HIGH Trial 302 312 383
Women’s Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction 776 742 745 761
Rule-Out Myocardial Infarction Using Computer Assisted Tomography (ROMICAT II)* 2,112 2,307 367
Collaborative Model To Improve BP Control and Minimize Racial Disparities 1,963 1,938 1,852
Multiscale Model of the Human Heart for Imaging Research 566 503 498
Catheter Ablation Versus Antiarrythmic Drug Therapy for Atrial Fibrillation (CABANA)* 2,941 3,045 3,033
Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA)* 3,648 2,285 4,402
Vitamin D and Omega 3 Trial (VITAL)* 1,260 1,248 1,210
Late Sodium Blockade in High-Risk ICD Patients* 2,280
Cardiovascular Inflammation Reduction Trial 1,376
Impact of Vitamin D Supplementation on Cardiometabolic Risk in School Children 552
Lifestyle, CVD Risk, and Cognitive Impairment 785
ISCHEMIA Trial (International Study of Comparative Effectiveness with Medical Invasive Approaches) 6,672
Subtotal, Heart and Vascular Diseases 22,996 45,253 52,210 52,377 56,681 58,312 45,091 22,538 27,909 37,309 32,358
Lung Diseases                      
Lung Health Study III* ** 1,672 927
Asthma Clinical Research Network (ACRN)* ** 5,705 5,863
Fetal Tracheal Occlusion for Severe Diaphragmatic Hernia* 181
Scleroderma Lung Study* 1,761 1,501 1,055 71
Inhaled Nitric Oxide for Prevention of Chronic Lung Disease* 1,803 1,764 1,442 1,245
Inhaled Nitric Oxide in Prevention of Chronic Lung Disease* 1,839 1,604 903
Prospective Investigation of Pulmonary Embolism Diagnosis II (PIOPED II)* 3,388 472
Randomized Trial To Reduce ETS in Children With Asthma 468 277
Apnea Positive Pressure Long-Term Efficacy Study (APPLES)* 3,224 3,021 3,110 3,188 1,532
Childhood Asthma Management Program-Continuation Study (CAMP-CS)/Phase II* ** 1,489 2,043 2,623 2,750
Acid Reflux Therapy in Asthma* 736 783 791 773 662
Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP) 682 612 608 694
Outcomes of Sleep Disorders in Older Men 4,163 4,262 1,390 1,142 910
Supplemental Selenium and Vitamin E and Pulmonary Function 698 610 630 605 561
Improving Asthma Care in Minority Children in Head Start 721 826 1,004 779
Randomized Controlled Study of Adenotonsillectomy for Childhood Sleep Apnea 2,255 2,388 1,346 2,501 1,675
Early Insulin Therapy and Development of ARDS 489 454 464 417 386
Childhood Asthma Management Program—Continuation Study (CAMP-CS)/Phase III* ** 2,077 1,966 1,146 2,065
Infant Study of Inhaled Saline in Cystic Fibrosis (ISIS)* 732 737 776 628
Scleroderma Lung Study II 2,281 2,297 2,252 2,268
Sedation Management in Pediatric Patients With Acute Respiratory Failure* 568 3,885 3,327 2,181
Study of Asthma and Nasal Steroids (STAN)* 725 725 725
Outpatient Treatment of Low-Risk Patients With Pulmonary Embolism 755 349
Translating COPD Guidelines Into Primary Care Practice 733 719
Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans 225 187
Physical Activity Self-Management in Patients With COPD 663 660 655
Study of Soy Isoflavones in Asthma (SOYA)* 775 697 689
Trial of Late Surfactant To Prevent Bronchopulmonary Dysplasia (TOLSURF)* 1,987 1,779 1,807
Randomized Trial of Maternal Vitamin D Supplementation To Prevent Childhood Asthma* 2,510 2,466 2,469
Effects of HIV Antiretroviral Therapy on Pulmonary Function 614 516 552
Randomized Trial of Antenatal Late Preterm Steroids (ALPS)* 2,134 2,137
Vitamin D Supplementation in Pregnancy:  Impact on Neonatal Immune Phenotype 323 311
Role of Beta-Catenin in Epithelial Repair in Acute Lung Injury 125 125
Mechanisms of Familial Pulmonary Fibrosis 2,330 2,252
Multicomponent Intervention To Decrease COPD-Related Hospitalizations 412 470
Heart and Lung Failure-Pediatric Insulin Titration (HALF-PINT) 2,685
Subtotal, Lung Diseases 17,076 18,974 15,639 14,289 10,056 9,294 9,398 7,347 20,017 23,934 20,340
Blood Diseases and Resources                      
Stroke Prevention in Sickle Cell Anemia (STOP 2)* 4,200 3,166 3,168 2,366
Induction of Stable Chimerism for Sickle Cell Anemia* 489 525 527 551
Sibling Donor Cord Blood Banking and Transplantation* 1,222 1,224 1,286 1,353
FOCUS* 1,639 1,796 2,923 2,446 1,974
Stroke With Transfusions Changing to Hydroxyurea (SWiTCH)* 3,345 3,932 3,531 3,828 3,216 1,778
Bridging Anticoagulation on Patients Requiring Temporary Interruption of Warfarin Therapy for an Elective Procedure or Surgery (BRIDGE) Trial* 4,632 5,673 5,227
Acute Venous Thrombosis:  Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT)* 2,071 2,108 2,094 244
Transcranial Doppler With Transfusions Changing to Hydroxyurea (TWiTCH) 4,176 4,177 4,391
Impact of Blood Storage Duration on Physiologic Measures:  RECESS Ancillary Study 389
Subtotal, Blood Diseases and Resources 4,877 4,917 5,772 6,066 6,268 6,378 5,505 10,531 15,173 13,663 5,024
Total, NHLBI $44,949 $69,144 $73,621 $72,732 $73,005 $73,984 $59,994 $40,416 $63,099 $74,906 $57,722

*Paid by U01/U10.
**Previously an Institute-Initiated Clinical Trial.
 Formerly known as Pharmacomechanical Catheter-Directed Thrombolysis for Acute DVT–ATTRACT Trial.

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NHLBI Investigator-Initiated Clinical Trials, Fiscal Year 2011: Summary by Program

 

Total Obligations
Prior to FY 2011
FY 2011
Obligations
Total Obligations
to Date
Heart and Vascular Diseases

 

 

 

AIM HIGH: Niacin Plus Statin To Prevent Vascular Events* $23,637,416 $1,088,603 $24,726,019
Cardiovascular Inflammation Reduction Trial* 1,375,726 1,375,726
Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)* 25,827,224 3,029,201 28,856,425
Catheter Ablation Versus Antiarrythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)* 5,985,643 3,032,875 9,018,518
Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)* 7,647,416 1,371,307 9,018,723
Collaborative Model To Improve BP Control and Minimize Racial Disparities 3,900,897 1,852,389 5,753,286
Efficacy of Smoking Quit Line in the Military 2,189,732 723,167 2,912,899
FREEDOM Trial:  Future Revascularization Evaluation in Patients With Diabetes Mellitus:  Optimal Management of Multivessel Disease 21,417,459 2,754,827 24,172,286
Impact of Vitamin D Supplementation on Cardiometabolic Risk in School Children 552,019 552,019
Interventions To Improve Warfarin Adherence 2,358,416 763,252 3,121,668
ISCHEMIA Trial (International Study of Comparative Effectiveness with Medical Invasive Approaches) 6,671,629 6,671,629
Lifestyle, CVD Risk, and Cognitive Impairment 784,998 784,998
Multiscale Model of the Human Heart for Imaging Research 1,068,817 498,049 1,566,866
Planned Care for Obesity and Risk Reduction (Planned CORR) 2,323,037 767,849 3,090,886
Rule-Out Myocardial Infarction Using Computer Assisted Tomography (ROMICAT II)* 4,419,188 366,525 4,785,713
Surgical Treatment for Ischemic Heart Failure (STICH)* 40,041,062 352,198 40,393,260
Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA)* 5,933,723 4,401,772 10,335,495
Vitamin D and Omega 3 Trial (VITAL)* 2,507,778 1,210,345 3,718,123
Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction 2,262,918 760,707 3,023,625
Subtotal, Heart and Vascular Diseases 151,520,726 32,357,438 183,878,164
Lung Diseases      
Early Insulin Therapy and Development of ARDS 1,824,699 386,117 2,210,816
Effects of HIV Antiretroviral Therapy on Pulmonary Function 1,129,948 552,353 1,682,301
Heart and Lung Failure-Pediatric Insulin Trial (HALF-PINT) 2,685,460 2,685,460
Infant Study of Inhaled Saline in Cystic Fibrosis (ISIS)* 2,244,874 628,241 2,873,115
Mechanisms of Familial Pulmonary Fibrosis 2,330,347 2,251,871 4,582,218
Multicomponent Intervention To Decrease COPD-Related Hospitalizations 411,777 469,910 881,687
Physical Activity Self-Management in Patients With COPD 1,323,114 654,594 1,977,708
Randomized Trial of Antenatal Late Preterm Steroids (ALPS)* 2,133,947 2,137,414 4,271,361
Randomized Trial of Maternal Vitamin D Supplementation To Prevent Childhood Asthma* 4,975,916 2,469,339 7,445,255
Role of Beta-Catenin in Epithelial Repair in Acute Lung Injury 125,172 125,172 250,344
Scleroderma Lung Study II 6,828,804 2,267,789 9,096,593
Sedation Management in Pediatric Patients With Acute Respiratory Failure* 7,779,116 2,181,199 9,960,315
Study of Asthma and Nasal Steroids (STAN)* 1,449,536 724,884 2,174,420
Study of Soy Isoflavones in Asthma (SOYA)* 1,471,854 688,673 2,160,527
Trial of Late Surfactant To Prevent Bronchopulmonary Dysplasia (TOLSURF)* 3,765,851 1,807,148 5,572,999
Vitamin D Supplementation in Pregnancy:  Impact on Neonatal Immune Phenotype 323,300 311,250 634,550
Subtotal, Lung Diseases 38,118,255 20,341,414 58,459,669
Blood Diseases and Resources      
Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT)* 6,272,537 243,775 6,516,312
Impact of Blood Storage Duration on Physiologic Measures:  RECESS Ancillary Study 386,523 389,405 775,928
Transcranial Doppler With Transfusions Changing to Hydroxyurea (TWiTCH) 8,353,426 4,390,891 12,744,317
Subtotal, Blood Diseases and Resources 15,012,486 5,024,071 20,036,557
TOTAL, NHLBI $204,651,467 $57,722,923 $262,374,390

* Paid by U01/U10.
** Previously an Institute-Initiated Clinical Trial.
Formerly known as Pharmacomechanical Catheter-Directed Thrombolysis for Acute DVT–ATTRACT Trial.

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Institute-Initiated Clinical Trials: Fiscal Years 2001–2011

Contracts

Dollars (Thousands)

  FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011
Heart and Vascular Diseases                      
Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT) 7,000 3,980 2,761 3,346 1,235 971
Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) 596 425 70
Atrial Fibrillation Follow-Up:Investigation in Rhythm Management (AFFIRM) 2,401 802
Women’s Angiographic Vitamin and Estrogen Trial (WAVE) 756 32
Women’s Ischemia Syndrome Evaluation (WISE) 10 50
Prevention of Events With Angiotensin Converting Enzyme Inhibitor Therapy (PEACE) 2,849 558
Magnesium in Coronaries (MAGIC) 238
Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) 1,129 311
Action To Control Cardiovascular Risk in Diabetes (ACCORD) 1,750 18,521 33,779 26,126 19,484 16,343 15,461 403
Public Access Defibrillation (PAD) Community Trial 3,058 1,101
Trial of Aldosterone Antagonist Therapy in Adults With Preserved Ejection Fraction Congestive Heart Failure (TOPCAT) 837 5,162 5,480 2,218 7,912 4,408 898
Women’s Health Initiative 59,200 59,010 63,222 57,483 37,826 12,124 14,873 22,609 30,615 2,409 22,766
Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) 4,953
Systolic Blood Pressure Intervention Trial (SPRINT) 3,057 29,374
Clarification of Optimal Anticoagulation Through Genetics (COAG)* 2,637 3,530 6,760
Subtotal, Heart and Vascular Diseases 73,021 71,334 85,164 95,445 69,114 17,915 36,575 49,501 57,071 34,319 35,450
Lung Diseases                      
Pediatric Pulmonary and Cardiac Complications of HIV Infection (P2C2) 113
Childhood Asthma Management Program (CAMP) 1,330 2,786 2,287 1,475 599
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) 2,667 1,502 4,402 5,517 4,707 7,396 5,037 1,992 6,195 7,208 5,096
Lung Diseases (continued)                      
National Emphysema Treatment Trial (NETT) 6,989 7,910 1,630 1,648 357 285
Feasibility of Retinoid Treatment in Emphysema (FORTE) 2,429 725 507 185
Long-Term Oxygen Treatment Trial (LOTT) 6,208 10,042 202 4,335 4,378
Subtotal, Lung Diseases 10,986 14,740 9,044 9,147 5,848 7,396 11,245 12,034 6,682 11,543 9,474
Blood Diseases and Resources                      
T-Cell Depletion in Unrelated Donor Marrow Transplantation 1,144 557 774 164
Cord Blood Stem Cell Transplantation Study (COBLT) 1,846 2,166 588 707 822
Multicenter Study of Hydroxyurea (MSH) in Sickle Cell Anemia Adult Follow-Up 588 994 1,136 1,340
Pediatric Hydroxyurea
Phase III Clinical Trial (BABY HUG)
405 3,100 1,112 1,964 1,526 891 3,966 5,573 1,704 853
Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension  (walk PHaSST) 1,867 2,801 3,702 963 320 212
Subtotal, Blood Diseases and Resources 3,395 6,411 3,468 3,971 3,688 2,758 6,767 9,275 2,667 320 1,065
Total, NHLBI Clinical Trials Contracts $87,402 $92,485 $97,676 $108,563 $78,650 $28,069 $54,587 $70,810 $66,420 $46,182 $45,989

* Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial.

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Cooperative Agreements

Dollars (Thousands)

  FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011
Heart and Vascular Diseases

 

 

 

 

 

 

 

 

 

 

 

Bypass Angioplasty Revascularization Investigation (BARI) $ 1,549 $ 1,456 $  — $  — $  — $  — $  — $  — $ — $ — $ —
Girls Health Enrichment Multisite Studies (GEMS) 2,877 2,713
Trial of Activity for Adolescent Girls (TAAG) 4,831 5,919 5,828 6,350 5,103 905
Pediatric Heart Network 3,447 4,822 5,381 4,948 3,992 6,988 6,607 12,255 7,637 7,471 12,827
Clinical Research Consortium To Improve Resuscitation Outcome 6,886 9,339 9,728 8,972 5,279 6,244 9,455
Dynamic Assessment of Patient-Reported Chronic Disease Outcomes 1,010
Heart Failure Clinical Research Network 5,642 7,801 7,813 7,939 7,914* 7,652
Pediatric HIV/AIDS Cohort Study (PHACS)—Data and Operations Center 1,000 500 490 500 769* 600
Cardiovascular Cell Therapy Research Network 4,424 7,568 6,227 6,200 3,800
Community-Responsive Interventions To Reduce Cardiovascular Risk in American Indians and Alaska Natives 1,419 2,314 3,151 1,999 2,071
Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine 6,009 8,681 3,210 8,079 5,460
EDTA Chelation Therapy for Coronary Artery Disease 2,109
Practice-Based Opportunity for Weight Reduction (POWER) Trials* 2,567 3,714 3,656 3,729 2,329
Look AHEAD: Action for Health in Diabetes 4,000 4,000
Diabetes Prevention Program Outcomes Study—Phase II 1,100 1,100
Early Adult Reduction of Weight Through LifestYle Intervention (EARLY) Trials** 4,656 5,864 6,124
Childhood Obesity Prevention and Treatment Research (COPTR) 4,058 3,986
Consortium of Hospitals Advancing Research on Tobacco (CHART)* 3,322 3,505
Subtotal, Heart and Vascular Diseases 12,704 14,910 11,209 19,194 18,434 28,249 40,341 48,893 43,106 59,421** 58,509
Lung Diseases                      
Asthma Clinical Research Network (ACRN) 8,181 8,424 8,667 7,839 8,918 872
Childhood Asthma Research and Education (CARE) Network 5,314 6,005 5,610 5,292 5,704 5,735 5,916 4,887
COPD Clinical Research Network 6,843 6,848 8,438 7,664 6,836 3,400 3,150 3,150 2,600
Idiopathic Pulmonary Fibrosis Clinical Research Network 3,486 7,349 7,216 7,154 7,325
NICHD Cooperative Multicenter Neonatal Research Network 1,336 238 27
Asthma Network (AsthmaNet) 8,300 15,500 15,500
Novel Therapies for Lung Diseases—Phase II 7,594 12,843
Subtotal, Lung Diseases 5,314 6,005 20,634 20,564 26,295 29,923 29,124 16,340 18,775 26,244 30,943
Blood Diseases and Resources                      
Thalassemia (Cooley’s Anemia) Clinical Research Network 2,219 2,269 2,320 2,375 2,730 2,682 2,618 2,600 658
Blood and Marrow Transplant Clinical Research Network 5,360 5,899 5,950 5,972 6,460 6,845 6,709 6,952 6,351 2,507 5,319
Transfusion Medicine/ Hemostasis Clinical Research Network 6,053 6,241 6,093 6,221 6,521 6,407 6,374 6,541 6,590 6,314
Sickle Cell Disease Clinical Research Network 3,761 7,498 7,173
Subtotal, Blood Diseases and Resources 7,579 14,221 14,511 14,440 15,411 19,809 23,232 23,099 13,550 9,097 11,453
Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements $25,597 $35,136 $46,354 $54,198 $60,140 $77,981 $92,697 $88,332 $75,431 $94,762** $100,905
Total, NHLBI-Initiated Clinical Trials $112,999 $127,621 $144,030 $162,761 $138,790 $106,050 $147,284 $159,142 $141,851 $140,944** $146,594

* Formerly known as Weight-Loss in Obese Adults With Cardiovascular Risk Factors.
**  Formerly known as Targeted Approaches to Weight Control for Young Adults.
Investigator-Initiated from 1998 to 2002.
Note: The line labeled "Other Clinical Trials" ($78.8 million) that appeared in the FY 2010 Fact Book has been removed.

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Institute-Initiated Clinical Trials, Fiscal Year 2011: Summary by Program

Contracts

 

Total Obligations
Prior to FY 2011
Total FY 2011
Obligations
Total Obligations
to Date
Heart and Vascular Diseases

 

 

 

Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT) $ 84,405,430 $ 971,242 $ 85,376,672
Clarification of Optimal Anticoagulation Through Genetics (COAG)* 6,167,062 6,760,320 12,927,382
Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) 4,952,781 4,952,781
Systolic Blood Pressure Intervention Trial (SPRINT) 36,882,407 36,882,407
Trial of Aldosterone Antagonists Therapy in Adults With Preserved Ejection Fraction Congestive Heart Failure (TOPCAT) 26,914,315 26,914,315
Women’s Health Initiative (WHI)** 793,070,018 22,766,227 815,836,245
Subtotal, Heart and Vascular Diseases  947,439,232 35,450,570 982,889,802
Lung Diseases      
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) 78,742,505 5,096,234 83,838,739
Long-Term Oxygen Treatment Trial (LOTT) 20,787,361 4,377,865 25,165,226
Subtotal, Lung Diseases 99,529,866 9,474,099 109,003,965
Blood Diseases and Resources      
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) 21,847,533 852,640 22,700,173
Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension (walk PHaSST) 9,653,177 212,144 9,865,321
Subtotal, Blood Diseases and Resources 31,500,710 1,064,784 32,565,494
Total, NHLBI-Initiated Clinical Trials, Contracts $1,078,469,808 $45,989,453 $1,124,459,261

* Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy.
** From 1999 to 2006, the WHI was reported separately under its own major heading.  In this table, it is included in the Heart and Vascular Diseases section.  

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Cooperative Agreements

 

Total Obligations
Prior to FY 2011
Total FY 2011
Obligations
Total Obligations
to Date
Heart and Vascular Diseases

 

 

 

Cardiovascular Cell Therapy Research Network $ 24,419,327 $  3,800,000 $ 28,219,327
Childhood Obesity Prevention and Treatment Research (COPTR) 4,058,435 3,986,427 8,044,862
Clinical Research Consortium To Improve Resuscitation Outcome 46,447,452 9,455,378 55,902,830
Consortium of Hospitals Advancing Research (CHART)* 3,321,649 3,505,096 6,826,745
Diabetes Prevention Program Outcomes Study—Phase II 2,200,000 1,100,000 3,300,000
Early Adult Reduction of Weight Through LifestYle Intervention (EARLY) Trials** 10,519,703 6,123,513 16,643,216
Heart Failure Clinical Research Network 37,108,888 7,651,786 44,760,674
Look AHEAD:  Action for Health in Diabetes 8,000,000 4,000,000 12,000,000
Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine 25,978,806 5,459,597 31,438,403
Pediatric Heart Network 63,348,873 12,827,177 76,176,050
Pediatric HIV/AIDS Cohort Study (PHACS):  Data and Operations Center 3,259,021 600,000 3,859,021
Subtotal, Heart and Vascular Diseases 228,662,154 58,508,974 287,171,128
Lung Diseases      
Asthma Network (AsthmaNet) 23,800,000 15,500,000 39,300,000
COPD Clinical Research Network 46,330,386 2,600,000 48,930,386
Novel Therapies for Lung Diseases—Phase II 7,593,739 12,843,238 20,436,977
Subtotal, Lung Diseases 77,724,125 30,943,238 108,667,363
Blood Diseases and Resources      
Blood and Marrow Transplant Clinical Research Network 59,071,021 5,319,784 64,390,805
Transfusion Medicine/Hemostasis Clinical Research Network 57,040,060 6,133,712 63,173,772
Subtotal, Blood Diseases and Resources 116,111,081 11,453,496 127,564,577
Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements $422,497,360 $100,905,708 $523,403,068
Total, NHLBI-Initiated Clinical Trials $1,500,967,868 $146,595,161 $1,647,863,029

*  Formerly known as Effectiveness Research on Smoking Cessation in Hospitalized Patients.
** Formerly known as Targeted Approaches to Weight Control for Young Adults.

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Heart and Vascular Diseases

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

The purpose of this study was to compare the ability of a diuretic versus newer antihypertensive treatments (ACE inhibitor, calcium channel blocker, alpha blocker) to lower the combined incidence of fatal CHD and nonfatal MI in high-risk hypertensive patients and to determine whether lowering serum cholesterol with an HMG CoA reductase inhibitor reduced the total mortality in a subset of hypertensive patients with moderately elevated LDL cholesterol.

In February 2000, the alpha blocker arm of the study was discontinued because the CVD event rate was significantly greater among those patients compared with those in the control group. In 2002, results showed that diuretics work best to both lower blood pressure and prevent stroke and some forms of heart disease, including heart attack and heart failure.

Researchers are analyzing a post-trial follow-up (9–10 years) of participants to compare long-term effects of antihypertensive treatment with a thiazide-type diuretic, a calcium channel blocker, an ACE inhibitor, and an alpha receptor blocker when each drug was used as initial treatment, with step-up drugs added as needed, and for the lipid component, to assess long-term effects of pravastatin compared with usual care. Fifty-five percent of the participants are black.

Obligations

Funding History:
Fiscal Year 2011—$971,242
Fiscal Years 1993–2010—$84,405,430
Total Funding to Date—$85,376,672

Current Active Organization and Contract Number

  1. University of Texas
    Health Science Center
    Houston, Texas —26820110036C

Cardiovascular Cell Therapy Research Network, Initiated in Fiscal Year 2007

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

Obligations

Funding History:
Fiscal Year 2011—$3,800,000
Fiscal Years 2007–2010—$24,419,327
Total Funding to Date—$28,219,327

Current Active Organizations and Grant Numbers

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

Childhood Obesity Prevention and Treatment Research (COPTR), Initiated in Fiscal Year 2010

The purpose of this research consortium is to test interventions to prevent excess weight gain in children and to reduce weight in obese children. Two obesity prevention trials are developing and testing approaches that target home, community, and primary care settings for preschool children living in low-income and ethnically diverse neighborhoods. Two obesity treatment trials are examining the therapies on overweight and obese children, 7- to 15-year olds, in school and home settings in collaboration with local youth organizations. More than 50 percent of the participants are expected to be from racial and ethnic minority populations.

Obligations

Funding History:
Fiscal Year 2011—$3,986,427
Fiscal Year 2010—$4,058,435
Total Funding to Date—$8,044,862

Current Active Organizations and Grant Numbers

  1. University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina   —HL-103561
  2. Vanderbilt University School of Medicine
    Nashville, Tennessee —HL-103620
  3. Case Western Reserve University
    Cleveland, Ohio  —HL-103622
  4. Stanford University
    Palo Alto, California  —HL-103629

Clarification of Optimal Anticoagulation Through Genetics (COAG),* Initiated in Fiscal Year 2008

The purpose of this randomized, multicenter clinical trial is to compare two approaches to the initiation of warfarin therapy for optimal anticoagulation. One approach uses clinical information and an individual’s genotype based on the genes known to influence warfarin response (“genotype-guided dosing”), and the other uses only clinical information (“clinical-guided dosing”). Approximately 1,200 participants are being randomized over a 3-year period at 18 medical centers throughout the United States. The primary endpoint is anticoagulation control during the first month of therapy. The trial is assessing anticoagulation control, bleeding problems and other complications, quality of life, and cost of therapy up to 6 months after initiation of therapy.

Obligations

Funding History:
Fiscal Year 2011—$6,760,320
Fiscal Years 2008–2010—$6,167,062
Total Funding to Date—$12,927,382

Current Active Organization and Contract Number

  1. University of Pennsylvania
    Philadelphia, Pennsylvania —26800800003C

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

The purpose of this program is to conduct research in cardiopulmonary arrest and severe traumatic injury to facilitate the rapid translation of promising scientific and clinical advances to improve resuscitation outcomes. The Consortium conducts multiple, collaborative clinical trials and studies that target primarily out-of-hospital clinical life compromising events, such as cardiac arrest and life threatening trauma.

Obligations

Funding History:
Fiscal Year 2011—$9,455,378
Fiscal Years 2004–2010—$46,447,452
Total Funding to Date—$55,902,830

Current Active Organizations and Grant Numbers

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

Consortium of Hospitals Advancing Research on Tobacco (CHART),** Initiated in Fiscal Year 2010

The purpose of this study is to evaluate the effectiveness of smoking cessation interventions in hospitalized patients. A network of six projects are assessing the effectiveness and cost effectiveness of smoking cessation interventions that are initiated during hospitalization and continued post-discharge in more than 10,000 hospitalized smokers across a geographically diverse group of nearly 20 private, public, academic, and community hospitals. Participation from minority populations is strong in some of the projects.

Obligations

Funding History:
Fiscal Year 2011—$3,505,096
Fiscal Year 2010—$3,321,649
Total Funding to Date—$6,826,745

*  Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy.
** Formerly known as Effective Research on Smoking Cessation in Hospitalized Patients.

Current Active Organizations and Grant Numbers

  1. University of Michigan at Ann Arbor
    Ann Arbor, Michigan —HL-105218
  2. New York University School of Medicine
    New York, New York —HL-105229
  3. Kaiser Foundation Research Institute
    Oakland, California   —HL-105231
  4. University of Kansas Medical Center
    Kansas City, Kansas —HL-105232
  5. Kaiser Foundation Research Institute
    Oakland, California   —HL-105233
  6. University of California, San Diego
    San Diego, California   —CA-159533
  7. University of Alabama at Birmingham
    Birmingham, Alabama —DA-031515

Diabetes Prevention Program Outcomes Study—Phase II, Initiated in Fiscal Year 2009

The purpose of this multicenter clinical trial is to determine the efficacy of treatments to prevent or delay the development of type 2 diabetes in a population at high risk due to the presence of impaired glucose tolerance. The Phase II trial will continue to follow the original cohort to determine the long-term effects of the interventions (metformin versus lifestyle) on further diabetes development, microvascular outcomes, and CVD and CVD risk factors. Forty-five percent of participants are from diverse minority populations.

Obligations

Funding History:
Fiscal Year 2011—$1,100,000
Fiscal Years 2009–2010—$2,200,000
Total Funding to Date—$3,300,000

Current Active Organizations and Grant Numbers

  1. University of Colorado
    Aurora, Colorado —DK-048375
  2. Louisiana State University
    Pennington Biomedical Research Center
    Baton Rouge, Louisiana   —DK-048377
  3. Northwestern University
    Chicago, Illinois —DK-048380
  4. University of Chicago
    Chicago, Illinois —DK-048381
  5. MEDSTAR Research Institute
    Hyattsville, Maryland —DK-048387
  6. St. Luke’s Roosevelt Institute for Health Sciences
    New York, New York —DK-048404
  7. Indiana University-Purdue
    University at Indianapolis
    Indianapolis, Indiana —DK-048406
  8. University of New Mexico
    Albuquerque, New Mexico —DK-048407
  9. University of Tennessee Health  Science Center
    Memphis, Tennessee —DK-048411
  10. Seattle Institute for Biomedical and Clinical Research
    Seattle, Washington   —DK-048413
  11. University of California, Los Angeles
    Los Angeles, California   —DK-048443
  12. Thomas Jefferson University
    Philadelphia, Pennsylvania —DK-048468
  13. Johns Hopkins University
    Baltimore, Maryland —DK-048485
  14. George Washington University
    Washington, DC —DK-048489
  15. University of Texas
    Health Science Center
    San Antonio, Texas   —DK-048514

Early Adult Reduction of Weight Through Lifestyle Intervention (EARLY) Trials,* Initiated in Fiscal Year 2009

*  Formerly known as Targeted Approaches to Weight Control for Young Adults.

The purpose of this program is to conduct two-phase clinical research to refine and test innovative behavioral approaches for weight control—using mobile phones, social networks, and Web-based curricula—in young adults, ages 18–35 years, who are at high risk for weight gain. Phase I involves refining proposed intervention, recruitment, retention, and adherence strategies. Phase II deals with testing the efficacy of the interventions that address weight loss, prevention of weight gain, or prevention of excessive weight gain during pregnancy. Targeted populations include pregnant and postpartum women, community college and university students, and young adults who are trying to quit smoking.

Obligations

Funding History:
Fiscal Year 2011—$6,123,513
Fiscal Years 2009–2010—$10,519,703
Total Funding to Date—$16,643,216

Current Active Organizations and Grant Numbers

  1. University of Tennessee Health Science Center
    Memphis, Tennessee —HL-096628
  2. University of California, San Diego
    La Jolla, California —HL-096715
  3. 3. Duke University
    Durham, North Carolina   —HL-096720
  4. Cornell University
    Ithaca, New York —HL-096760
  5. University of Minnesota, Twin Cities
    Minneapolis, Minnesota   —HL-096767
  6. University of Pittsburgh
    Pittsburgh, Pennsylvania —HL-096770

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 to improve outcomes through optimal application of existing therapies and evaluation of innovative therapies. The network provides 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 2011—$7,651,786
Fiscal Years 2006–2010—$37,108,888
Total Funding to Date—$44,760,674

Current Active Organizations and Grant Numbers

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

Look AHEAD: Action for Health in Diabetes, Initiated in Fiscal Year 2009

The purpose of this multicenter randomized clinical trial is to determine the effect of a lifestyle intervention—designed to achieve and maintain weight loss over the long term through decreased caloric intake and exercise—in obese individuals with type 2 diabetes. More than 5,000 participants have been randomly assigned to one of two interventions—either Lifestyle Intervention or Diabetes Support and Education—and will be followed for up to 11.5 years. The trial is monitoring major cardiovascular events, such as heart attack, stroke, and cardiovascular-related death. Investigators are also examining the impact of the interventions on other cardiovascular disease-related outcomes, cardiovascular risk factors, all-cause mortality, diabetes control and complications, fitness, general health, and health-related quality of life and psychological outcomes. One of the 16 clinical centers is targeting American Indians.

Obligations

Funding History:
Fiscal Year 2011—$4,000,000
Fiscal Years 2009–2010—$8,000,000
Total Funding to Date—$12,000,000

Current Active Organizations and Grant Numbers

  1. University of Alabama at Birmingham
    Birmingham, Alabama   —DK-057008
  2. University of Tennessee Health Science Center
    Memphis, Tennessee   —DK-057078
  3. University of Pennsylvania
    Philadelphia, Pennsylvania —DK-057135
  4. University of Colorado
    Denver, Colorado —DK-057151

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

The purpose of this program is to establish a network to evaluate newer surgical techniques, technologies, devices, and innovative pharmaceutical and bioengineered products directed at CVD. The Network conducts randomized clinical trials and clinical studies that provide a strong evidence base to inform surgical practice and disseminates its findings to the broader scientific community. The Network also serves as a clinical trials training ground for fellows and junior faculty.

Obligations

Funding History:
Fiscal Year 2011—$5,459,597
Fiscal Years 2007–2010—$25,978,806
Total Funding to Date—$31,438,403

Current Active Organizations and Grant Numbers

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

Pediatric Heart Network, Initiated in Fiscal Year 2001

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

Obligations

Funding History:
Fiscal Year 2011—$12,827,177
Fiscal Years 2001–2009—$63,348,873
Total Funding to Date—$76,176,050

Current Active Organizations and Grant Numbers

  1. New England Research Institute, Inc.
    Watertown, Massachusetts —HL-068270
  2. Children’s Hospital Medical Center
    Cincinnati, Ohio —HL-109673
  3. University of Michigan at Ann Arbor
    Ann Arbor, Michigan —HL-109737
  4. Baylor College of Medicine
    Houston, Texas  —HL-109741
  5. University of Utah
    Salt Lake City, Utah —HL-109743
  6. Hospital for Sick Children
    Toronto, Ontario   —HL-109777
  7. Medical University of South Carolina
    Charleston, South Carolina —HL-109778
  8. Emory University
    Atlanta, Georgia —HL-109781
  9. Children’s Hospital
    Boston, Massachusetts   —HL-109816
  10. Children’s Hospital of Philadelphia
    Philadelphia, Pennsylvania —HL-109818

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

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

Obligations

Funding History:
Fiscal Year 2011—$600,000
Fiscal Years 2006–2010—$3,259,021
Total Funding to Date—$3,859,021

Current Active Organization and Contract Number

  1. Harvard University
    Boston, Massachusetts —HD-052102

Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT), Initiated in Fiscal Year 2011

The purpose of this clinical feasibility study is to explore the potential benefit of mechanical circulatory support therapy using ventricular assist devices (VADs) in functionally-impaired advanced heart failure patients who have not yet developed serious consequences from their disease. The study will serve to inform a pivotal trial directed at a large and growing patient population for whom VADs could offer substantial benefit beyond current medical therapies.

Obligations

Funding History:
Fiscal Year 2011—$4,952,781
Total Funding to Date—$4,952,781

Current Active Organization and Contract Number:

  1. University of Michigan at Ann Arbor
    Ann Arbor, Michigan  —268201100026C

Systolic Blood Pressure Intervention Trial (SPRINT), Initiated in Fiscal Year 2009

The purpose of this study is to determine whether intensive lowering of systolic blood pressure below the currently recommended standard reduces the risk of cardiovascular and kidney diseases or age-related cognitive decline. About 7,500 participants with systolic blood pressure ≥130 mm Hg are being recruited at more than 80 clinics in 5 clinical center networks during a 2-year period and will be followed for 4–6 years. Among the participants, approximately 4,300 will have chronic kidney disease and 3,250 will be aged 75 years and older. The primary endpoints are nonfatal MI, acute coronary syndrome, stroke, heart failure, or CVD mortality.  Secondary endpoints include decline in renal function or development of end stage renal disease. The MIND substudy is focusing on the effectiveness of lowering systolic blood pressure on reducing the decline in cognitive function.

Obligations

Funding History:
Fiscal Year 2011—$0
Fiscal Years 2009–2010—$36,882,407
Total Funding to Date—$36,882,407

Current Active Organizations and Contract Numbers

  1. Wake Forest University Health Science Center
    Winston-Salem, North Carolina     —HC-95240
  2. University of Utah
    Salt Lake City, Utah    —HC-95255
  3. University of Birmingham
    Birmingham, Alabama  —HC-95256
  4. Wake Forest University Health Science Center
    Winston-Salem, North Carolina    —HC-95257
  5. Case Western Reserve University
    Cleveland, Ohio  —HC-95258
  6. Department of Veterans Affairs, Memphis
    Memphis, Tennessee  —HV-0514

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

The purpose of this international randomized trial is to evaluate the effectiveness of spironolactone, a generic and inexpensive drug, to reduce cardiovascular mortality and heart failure hospitalization in patients who have heart failure with preserved systolic function (left ventricular ejection fraction ≥45 percent). The trial is recruiting up to 3,500 patients in Argentina, Brazil, Canada, Republic of Georgia, Russia, and the United States.

Obligations

Funding History:
Fiscal Year 2011—$0
Fiscal Years 2004–2010—$26,914,315
Total Funding to Date—$26,914,315

Current Active Organizations and Contract Numbers

  1. HHS Program Support Center, Supply Service Center
    Perry Point, Maryland   —HC-4071
  2. New England Research Institutes, Inc.
    Watertown, Massachusetts   —HC-45207

Women’s Health Initiative (WHI), Initiated in Fiscal Year 1992

The WHI was established to elucidate the etiology and prevention of CVD, cancers, and osteoporosis in women aged 50–79 years. The program consists of three primary components:  randomized controlled clinical trials of hormone therapy, 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. Total participation includes 161,808 women, for whom 17 percent are from minority populations.

Currently, investigators are determining the long-term effects of prior hormone therapy on the cohort that participated in the clinical trials of hormone therapy. Minority participants are being followed to improve statistical power for genetic association. Self-reported outcome data are being collected and will be available for ancillary studies and a new generation of clinical trials. The rich resources of data and specimens are available to the scientific community and for training young investigators.

Obligations

Funding History:
Fiscal Year 2011—$22,766,227
Fiscal Years 1992–2010*—$793,070,018
Total Funding to Date—$815,836,245

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

Current Active Organizations and Contract Numbers

  1. State University of New York, Buffalo
    Buffalo, New York —268201100001
  2. Ohio State University Research Foundation
    Columbus, Ohio   —268201100002
  3. Stanford University
    Stanford, California —268201100003
  4. Wake Forest University Health Sciences
    Winston-Salem, North Carolina —268201100004
  5. Fred Hutchinson Cancer Research Center
    Seattle, Washington  —268201100046
  6. Wake Forest University Health Sciences
    Winston-Salem, North Carolina —268200464221

Lung Diseases

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 and treat acute lung injury, ARDS, and other related critical illnesses and improve the outcome of patients with them.

Obligations

Funding History:
Fiscal Year 2011—$5,096,234
Fiscal Years 1994–2010—$78,742,505
Total Funding to Date—$83,838,739

Current Active Organizations and Contract Numbers

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

Asthma Network (AsthmaNet), Initiated in Fiscal Year 2009

The purpose of this network is to develop and conduct multiple clinical trials of asthma management in pediatric and adult populations.  Investigators are seeking to identify optimal therapies for a variety of asthma phenotypes, genotypes, and racial and ethnic backgrounds. They are also conducting a limited number of proof-of-concept studies to advance the development of innovative therapies and perform studies to investigate the mechanistic bases for the interventions. Approximately 30 percent of the participants will be from diverse minority populations.

Obligations

Funding History:
Fiscal Year 2011—$15,500,000
Fiscal Years 2009–2010—$23,800,000
Total Funding to Date—$39,300,000

Current Active Organizations and Grant Numbers

  1. National Jewish Health
    Denver, Colorado —HL-098075
  2. University of Wisconsin, Madison
    Madison, Wisconsin —HL-098090
  3. Northwestern University
    Chicago, Illinois —HL-098096
  4. Washington University
    St. Louis, Missouri —HL-098098
  5. Brigham and Women’s Hospital
    Boston, Massachusetts —HL-098102
  6. Wake Forest University Health Science Center
    Winston-Salem, North Carolina   —HL-098103
  7. University of California, San Francisco
    San Francisco, California —HL-098107
  8. University of Arizona
    Tucson, Arizona —HL-098112
  9. Pennsylvania State University
    Hershey, Pennsylvania —HL-098115
  10. University of Pittsburgh
    Pittsburgh, Pennsylvania  —HL-098177

COPD Clinical Research Network, Initiated in Fiscal Year 2003

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

Obligations

Funding History:
Fiscal Year 2011—$2,600,000
Fiscal Years 2003–2010—$46,330,386
Total Funding to Date—$48,930,386

Current Active Organizations and Grant Numbers

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

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

The purpose of this program is to determine the effectiveness and safety of long-term oxygen therapy in patients with COPD. Approximately 1,100 patients with moderate COPD are being enrolled to determine whether supplemental oxygen can improve their quality of life and extend their lifespan. Research findings will help the Centers for Medicare and Medicaid Services decide whether to extend Medicare coverage for home oxygen treatment for patients with moderately severe disease.

Obligations

Funding History:
Fiscal Year 2011—$4,377,865
Fiscal Years 2007–2010—$20,787,361
Total Funding to Date—$25,165,226

Current Active Organizations and Contract Numbers

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

Novel Therapies for Lung Diseases—Phase II, Initiated in Fiscal Year 2010

The purpose of this study is to conduct proof-of-concept Phase II clinical trials of innovative interventions for a sleep-associated lung disease or a cardiopulmonary disorder. Investigators are seeking to identify interventions that will have the potential to improve clinical management.

Obligations

Funding History:
Fiscal Year 2011—$12,843,238
Fiscal Year 2010—$7,593,739
Total Funding to Date—$20,436,977

Current Active Organizations and Grant Numbers

  1. Brigham and Women’s Hospital
    Boston, Massachusetts —HL-102225
  2. University of Colorado Denver
    Aurora, Colorado  —HL-102235
  3. University of Iowa
    Iowa City, Iowa —HL-102288
  4. Fred Hutchinson Cancer Research Center
    Seattle, Washington —HL-102547
  5. University of Wisconsin
    Madison, Wisconsin  —HL-105365
  6. Brigham and Women’s Hospital
    Boston, Massachusetts —HL-105371
  7. Johns Hopkins University
    Baltimore, Maryland —HL-105569
  8. Mayo Clinic
    Rochester, Minnesota  —HL-108712
  9. University of California, San Francisco
    San Francisco, California —HL-108713
  10. Johns Hopkins University
    Baltimore, Maryland —HL-108730

Blood Diseases and Resources

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

The purpose of this network is to compare innovative treatment methods and management strategies of potential benefit for patients undergoing blood or marrow transplantation.

Obligations

Funding History:
Fiscal Year 2011—$5,319,784
Fiscal Years 2001–2010—$59,071,021
Total Funding to Date—$64,390,805

Current Active Organizations and Grant Numbers

  1. University of Nebraska Medical Center
    Omaha, Nebraska —HL-069233
  2. Fred Hutchinson Cancer Research Center
    Seattle, Washington —HL-069246
  3. Dana Farber Cancer Institute
    Boston, Massachusetts —HL-069249
  4. National Childhood Cancer Foundation
    Arcadia, California  —HL-069254
  5. Duke University
    Durham, North Carolina —HL-069274
  6. City of Hope Medical Center
    Duarte, California —HL-069278
  7. University of Pennsylvania
    Philadelphia, Pennsylvania —HL-069286
  8. University of Minnesota, Twin Cities
    Minneapolis, Minnesota —HL-069290
  9. Stanford University
    Stanford, California  —HL-069291
  10. Medical College of Wisconsin
    Milwaukee, Wisconsin —HL-069294
  11. University of Florida
    Gainesville, Florida  —HL-069301
  12. Johns Hopkins University
    Baltimore, Maryland —HL-069310
  13. Sloan Kettering Institute for Cancer Research
    New York, New York —HL-069315
  14. University of Michigan at Ann Arbor
    Ann Arbor, Michigan —HL-069330
  15. University of Texas  MD Anderson Cancer Center
    Houston, Texas  —HL-069334
  16. Case Western Reserve University
    Cleveland, Ohio  —HL-069348
  17. Baylor College of Medicine
    Houston, Texas  —HL-108945
  18. H. Lee Moffitt Cancer Center
    Tampa, Florida —HL-108987
  19. Washington University
    St. Louis, Missouri —HL-109137
  20. Ohio State University
    Columbus, Ohio —HL-109322
  21. Northside Hospital Atlanta
    Atlanta, Georgia —HL-109526

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 preventing chronic end organ damage in pediatric patients with SCD.

Obligations

Funding History:
Fiscal Year 2011—$852,640
Fiscal Years 2000–2010—$21,847,533
Total Funding to Date—$22,700,173

Current Active Organizations and Contract Numbers

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

Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension (walk PHaSST), Initiated in Fiscal Year 2006

The purpose of this clinical trial is to evaluate the safety and efficacy of 16 weeks of therapy with sildenafil, a nitric oxide potentiator, in adult patients with SCD and pulmonary hypertension. Exercise endurance and pulmonary artery pressure were measured. Pulmonary hypertension occurs in up to 30 percent of SCD cases and is strongly associated with mortality in adults with SCD. All of the participants are black.

The trial was stopped nearly 1 year early because the treatment group experienced either increased hospitalizations for sickle cell crises or severe pain compared with the control group. The follow-up study is using datasets and biorepository specimens from the closed trial to assess the effect of genetic factors on hematologic, cardiopulmonary, and pain phenotypes in individuals with hemoglobin SS disease and to explore phenotypic variations in individuals with hemoglobin SC disease.

Obligations

Funding History:
Fiscal Year 2011—$212,144
Fiscal Years 2006–2010—$9,653,177
Total Funding to Date—$9,865,321

Current Active Organizations and Contract Numbers

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

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

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

Obligations

Funding History:
Fiscal Year 2011—$6,133,712
Fiscal Years 2002–2010—$57,040,060
Total Funding to Date—$63,173,772

Current Active Organizations and Grant Numbers

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

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