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 2002–2012

Research Grants and Cooperative Agreements (Dollars in Thousands)

  FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 FY 2012
Heart and Vascular Diseases                      
Women’s Health Study (WHS) $    — $    — $    — $    889 $    — $    868 $    875 $    919 $    927 $    — $    —
Women’s Antioxidant and Cardiovascular Study (WACS) 598 592 599 670
Stress Reduction and Atherosclerotic CVD in Blacks 376 394
Shock Trial:  Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock? 298 291 296
Dietary Patterns, Sodium Intake, and Blood Pressure (DASH Sodium)* ** 387 376 395
Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)* 1,412 1,930
CVD Risk and Health in Post-Menopausal Phytoestrogen Users 304 152
Prevention of Recurrent Venous Thromboembolism (PREVENT) 1,272
PREMIER:  Lifestyle Interventions for Blood Pressure Control* 1,505
Azithromycin and Coronary Events Study (ACES)* 1,254 1,137
Antiarrhythmic Effects of N-3 Fatty Acids 647
Occluded Artery Trial (OAT)* 1,724 1,963 963 1,452 1,277 1,270 1,033
Bypass Angioplasty Revascularization Investigation in Type 2 Diabetics (BARI 2D)* 9,342 8,189 8,265 8,304 8,592 2,647 1,971 1,130
Hematocrit Strategy in Infant Heart Surgery* 596 590 492
Angiotensin-II Blockade in Mitral Regurgitation 610 629 500
Heart Failure Adherence and Retention Trial (HART) 1,617 1,453 1,174 862 740 304
Reduction of Triglycerides in Women on HRT 746 555 544 721 625 501
Women’s Ischemia Syndrome Evaluation (WISE)* ** 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 2,882
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 1,384
Claudication:  Exercise Versus Endoluminal Revascularization (CLEVER)* 1,368 1,478 1,898 1,822 1,080 1,371 542
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 739 720 731 723 737
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) 784 770 769 768 642
Effects of Niacin on Lp(a), Oxidized LDL, and Inflammation on the AIM-HIGH Trial 302 312 383 428
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 1,105
Collaborative Model To Improve BP Control and Minimize Racial Disparities 1,963 1,938 1,852 1,689
Multiscale Model of the Human Heart for Imaging Research 566 503 498 498
Catheter Ablation Versus Antiarrythmic Drug Therapy for Atrial Fibrillation (CABANA)* 2,941 3,045 3,033 3,015
Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA)* 3,648 2,285 4,402 4,371
Vitamin D and Omega 3 Trial (VITAL)* 1,260 1,248 1,210 1,210
Late Sodium Blockade in High-Risk ICD Patients* 2,280 2,288
Cardiovascular Inflammation Reduction Trial (CIRT)* 1,376 9,607
Impact of Vitamin D Supplementation on Cardiometabolic Risk in School Children 552 650
Lifestyle, CVD Risk, and Cognitive Impairment 785 753
ISCHEMIA Trial (International Study of Comparative Effectiveness with Medical Invasive Approaches) 6,672 17,445
Guiding Evidence-Based Therapy Using Biomarker Intensified Treatment 3,893
Heart Camp:  Promoting Adherence to Exercise in Patients With Heart Failure 749
Impact of Vitamin D Supplementation on Cardiac Structure and Function 307
PDE5 Inhibition With Tadalafil Changes Outcome in Heart Failure (PITCH-HF)* 1,423
Subtotal, Heart and Vascular Diseases 45,253 52,210 52,377 56,681 58,312 45,091 22,538 27,909 37,309 32,358 55,618
Lung Diseases                      
Lung Health Study III* ** 927
Asthma Clinical Research Network (ACRN)* ** 5,863
Scleroderma Lung Study* 1,501 1,055 71
Inhaled Nitric Oxide for Prevention of Chronic Lung Disease* 1,764 1,442 1,245
Inhaled Nitric Oxide in Prevention of Chronic Lung Disease* 1,604 903
Prospective Investigation of Pulmonary Embolism Diagnosis II (PIOPED II)* 472
Randomized Trial To Reduce ETS in Children With Asthma 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 1,950
Sedation Management in Pediatric Patients With Acute Respiratory Failure* 568 3,885 3,327 2,181 385
Study of Asthma and Nasal Steroids (STAN)* 725 725 725 725
Outpatient Treatment of Low-Risk Patients With Pulmonary Embolism 755 349
Translating COPD Guidelines Into Primary Care Practice 733 719 663 680
Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans 225 187
Physical Activity Self-Management in Patients With COPD 663 660 655 622
Study of Soy Isoflavones in Asthma (SOYA)* 775 697 689 687
Trial of Late Surfactant To Prevent Bronchopulmonary Dysplasia (TOLSURF)* 1,987 1,779 1,807 1,653
Randomized Trial of Maternal Vitamin D Supplementation To Prevent Childhood Asthma* 2,510 2,466 2,469 2,506
Effects of HIV Antiretroviral Therapy on Pulmonary Function 614 516 552
Randomized Trial of Antenatal Late Preterm Steroids (ALPS)* 2,134 2,137 557
Vitamin D Supplementation in Pregnancy:  Impact on Neonatal Immune Phenotype 323 311 309
Role of Beta-Catenin in Epithelial Repair in Acute Lung Injury 125 125 125
Mechanisms of Familial Pulmonary Fibrosis 2,330 2,252 2,207
Multicomponent Intervention To Decrease COPD-Related Hospitalizations 412 470 490
Heart and Lung Failure-Pediatric Insulin Titration (HALF-PINT) 2,685 2,548
Subtotal, Lung Diseases 18,974 15,639 14,289 10,056 9,294 9,398 7,347 20,017 23,934 21,003 15,444
Blood Diseases and Resources                      
Stroke Prevention in Sickle Cell Anemia (STOP 2)* 3,166 3,168 2,366
Induction of Stable Chimerism for Sickle Cell Anemia* 525 527 551
Sibling Donor Cord Blood Banking and Transplantation* 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 2,459
Transcranial Doppler With Transfusions Changing to Hydroxyurea (TWiTCH) 4,176 4,177 4,391 4,746
Impact of Blood Storage Duration on Physiologic Measures:  RECESS Ancillary Study 389 416
Transfusion-Associated Brain Improvement (TABI)* 1,729
Subtotal, Blood Diseases and Resources 4,917 5,772 6,066 6,268 6,378 5,505 10,531 15,173 13,663 5,024 9,350
Total, NHLBI $69,144 $73,621 $72,732 $73,005 $73,984 $59,994 $40,416 $63,099 $74,906 $58,385 $80,412

*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 2012: Summary by Program

 

Total Obligations
Prior to 2012
FY 2012 Obligations Total Obligation
to Date
Heart and Vascular Diseases      
AIM HIGH: Niacin Plus Statin To Prevent Vascular Events* $24,726,019 $1,383,800 $26,109,819
Cardiovascular Inflammation Reduction Trial (CIRT)* 1,375,726 9,607,234 10,982,960
Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)* 28,856,425 2,881,799 31,738,224
Catheter Ablation Versus Antiarrythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)* 9,018,518 3,015,483 12,034,001
Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)* 9,018,723 542,213 9,560,936
Collaborative Model To Improve BP Control and Minimize Racial Disparities 5,753,286 1,689,074 7,442,360
Effects of Niacin on Lp(a), Oxidized LDL, and Inflammation on the AIM-HIGH Trial 997,247 428,498 1,425,745
Efficacy of Smoking Quit Line in the Military 2,912,899 737,487 3,650,386
Guiding Evidence-Based Therapy Using Biomarker Intensified Treatment 3,892,783 3,892,783
Heart Camp:  Promoting Adherence to Exercise in Patients With Heart Failure 749,122 749,122
Impact of Vitamin D Supplementation on Cardiac Structure and Function 307,048 307,048
Impact of Vitamin D Supplementation on Cardiometabolic Risk in School Children 552,019 649,893 1,201,912
ISCHEMIA Trial (International Study of Comparative Effectiveness With Medical Invasive Approaches)* 6,671,629 17,444,758 24,116,387
Late Sodium Blockade in High-Risk ICD Patients* 2,279,794 2,287,927 4,567,721
Lifestyle, CVD Risk, and Cognitive Impairment 784,998 753,104 1,538,102
Multiscale Model of the Human Heart for Imaging Research 1,566,866 498,049 2,064,915
PDE5 Inhibition with Tadalafil Changes Outcomes in Heart Failure (PITCH-HF) 1,422,791 1,422,791
Planned Care for Obesity and Risk Reduction (Planned CORR) 3,090,886 642,148 3,733,034
Rule-Out Myocardial Infarction Using Computer Assisted Tomography (ROMICAT II)* 4,785,713 1,105,318 5,891,031
Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA)* 10,335,495 4,370,676 14,706,171
Vitamin D and Omega 3 Trial (VITAL)* 3,718,123 1,210,345 4,928,468
Subtotal, Heart and Vascular Diseases 116,444,366 55,619,550 172,063,916
Lung Diseases      
Heart and Lung Failure-Pediatric Insulin Trial (HALF-PINT)* 2,685,460 2,548,137 5,233,597
Mechanisms of Familial Pulmonary Fibrosis 4,582,218 2,206,692 6,788,910
Multicomponent Intervention To Decrease COPD-Related Hospitalizations 881,687 489,881 1,371,568
Physical Activity Self-Management in Patients With COPD 1,977,708 622,213 2,599,921
Randomized Trial of Antenatal Late Preterm Steroids (ALPS)* 4,271,361 556,659 4,828,020
Randomized Trial of Maternal Vitamin D Supplementation to Prevent Childhood Asthma* 7,445,255 2,505,636 9,950,891
Role of Beta-Catenin in Epithelial Repair in Acute Lung Injury 250,344 125,172 375,516
Scleroderma Lung Study II 9,096,593 1,950,312 11,046,905
Sedation Management in Pediatric Patients With Acute Respiratory Failure* 9,960,315 384,556 10,344,871
Study of Asthma and Nasal Steroids (STAN)* 2,174,420 724,801 2,899,221
Study of Soy Isoflavones in Asthma (SOYA)* 2,160,527 687,123 2,847,650
Translating COPD Guidelines Into Primary Care Practice 2,114,902 680,329 2,795,231
Trial of Late Surfactant To Prevent Bronchopulmonary Dysplasia (TOLSURF)* 5,572,999 1,653,180 7,226,179
Vitamin D Supplementation in Pregnancy: Impact on Neonatal Immune Phenotype 634,550 308,582 943,132
Subtotal, Lung Diseases 53,808,339 15,443,273 69,251,612
Blood Diseases and Resources      
Acute Venous Thrombosis:  Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT)* ** 6,516,312 2,459,244 8,975,556
Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Study 775,928 416,355 1,192,283
Transcranial Doppler With Transfusions Changing to Hydroxyurea (TWiTCH) 12,744,317 4,746,356 17,490,673
Transfusion-Associated Brain Improvement (TABI)* 1,729,189 1,729,189
Subtotal, Blood Diseases and Resources 20,036,557 9,351,144 29,387,701
TOTAL, NHLBI $190,289,262 $80,413,967 $270,703,229

* 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 2002–2012

Contracts

Dollars (Thousands)

  FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 FY 2012
Heart and Vascular Diseases                      
Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT) 3,980 2,761 3,346 1,235 971 974
Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) 425 70
Atrial Fibrillation Follow-Up:Investigation in Rhythm Management (AFFIRM) 802
Women’s Angiographic Vitamin and Estrogen Trial (WAVE) 32
Women’s Ischemia Syndrome Evaluation (WISE) 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 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 2,825
Women’s Health Initiative 59,010 63,222 57,483 37,826 12,124 14,873 22,609 30,615 2,409 22,766 21,910
Systolic Blood Pressure Intervention Trial (SPRINT) 3,057 29,374
Clarification of Optimal Anticoagulation Through Genetics (COAG)* 2,637 3,530 6,760
Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) 4,953
Pumps for Kids, Infants, and Neonates (PumpKIN)** 1,808
Subtotal, Heart and Vascular Diseases 71,334 85,164 95,445 69,114 17,915 36,575 49,501 57,071 34,319 35,450 27,517
Lung Diseases                      
Pediatric Pulmonary and Cardiac Complications of HIV Infection (P2C2) 113
Childhood Asthma Management Program (CAMP) 2,786 2,287 1,475 599
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) 1,502 4,402 5,517 4,707 7,396 5,037 1,992 6,195 7,208 5,096 4,886
National Emphysema Treatment Trial (NETT) 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 7,562
Subtotal, Lung Diseases 14,740 9,044 9,147 5,848 7,396 11,245 12,034 6,682 11,543 9,474 12,448
Blood Diseases and Resources                      
T-Cell Depletion in Unrelated Donor Marrow Transplantation 557 774 164
Cord Blood Stem Cell Transplantation Study (COBLT) 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)
3,100 1,112 1,964 1,526 891 3,966 5,573 1,704 853 8,501
Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension  (walk PHaSST) 1,867 2,801 3,702 963 320 212
Subtotal, Blood Diseases and Resources 6,411 3,468 3,971 3,688 2,758 6,767 9,275 2,667 320 1,065 8,501
Total, NHLBI Clinical Trials Contracts $92,485 $97,676 $108,563 $78,650 $28,069 $54,587 $70,810 $66,420 $46,182 $45,989 $48,466

* Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial.
**  See Chapter 10 for preclinical PumpKIN R&D.

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Cooperative Agreements

Dollars (Thousands)

  FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 FY 2012
Heart and Vascular Diseases            

 

       
Bypass Angioplasty Revascularization Investigation (BARI) $ 1,456 $  — $  — $  — $  — $  — $  — $ — $ — $ — $ —
Girls Health Enrichment Multisite Studies (GEMS) 2,713
Trial of Activity for Adolescent Girls (TAAG) 5,919 5,828 6,350 5,103 905
Pediatric Heart Network 4,822 5,381 4,948 3,992 6,988 6,607 12,255 7,637 7,471 12,827 12,020
Resuscitation Outcomes Consortium (ROC)* 6,886 9,339 9,728 8,972 5,279 6,244 9,455 9,374
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 6,460
Pediatric HIV/AIDS Cohort Study (PHACS)—Data and Operations Center 1,000 500 490 500 769* 600 1,716
Cardiovascular Cell Therapy Research Network 4,424 7,568 6,227 6,200 3,800 5,783
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 7,097
EDTA Chelation Therapy for Coronary Artery Disease 2,109 908
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 4,000 4,000
Diabetes Prevention Program Outcomes Study—Phase II 1,100 1,100 1,100 2,426
Early Adult Reduction of Weight Through LifestYle Intervention (EARLY) Trials 4,656 5,864 6,124 4,858
Childhood Obesity Prevention and Treatment Research (COPTR) 4,058 3,986 7,528
Consortium of Hospitals Advancing Research on Tobacco (CHART)* 3,322 3,505 4,933
Subtotal, Heart and Vascular Diseases 14,910 11,209 19,194 18,434 28,249 40,341 48,893 43,106 59,421** 58,509 67,103
Lung Diseases                      
Asthma Clinical Research Network (ACRN)** 8,181 8,424 8,667 7,839 8,918 872 114
Childhood Asthma Research and Education (CARE) Network 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 16,465
Novel Therapies for Lung Diseases—Phase II 7,594 12,843 15,478
Subtotal, Lung Diseases 6,005 20,634 20,564 26,295 29,923 29,124 16,340 18,775 26,244 30,943 32,057
Blood Diseases and Resources                      
Thalassemia (Cooley’s Anemia) Clinical Research Network 2,269 2,320 2,375 2,730 2,682 2,618 2,600 658
Blood and Marrow Transplant Clinical Research Network 5,899 5,950 5,972 6,460 6,845 6,709 6,952 6,351 2,507 5,319 4,052
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 5,903
Sickle Cell Disease Clinical Research Network 3,761 7,498 7,173
Subtotal, Blood Diseases and Resources 14,221 14,511 14,440 15,411 19,809 23,232 23,099 13,550 9,097 11,453 9,955
Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements $35,136 $46,354 $54,198 $60,140 $77,981 $92,697 $88,332 $75,431 $94,762** $100,905 $109,114
Total, NHLBI-Initiated Clinical Trials $127,621 $144,030 $162,761 $138,790 $106,050 $147,284 $159,142 $146,302 $140,944** $146,594 $157,580

*    Formerly known as Clinical Research Consortium To Improve Resuscitation Outcome.
**   Correction to figure that was reported in the FY 2010 Fact Book.
     Formerly known as Weight Loss in Obese Adults With Cardiovascular Risk Factors.
     Formerly known as Targeted Approaches to Weight Control for Young Adults.
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 2012: Summary by Program

Contracts

 

Total Obligations
Prior to FY 2012
Total FY 2012
Obligations
Total Obligations
to Date
Heart and Vascular Diseases      
Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT) $85,376,672 $973,725 $86,350,397
Clarification of Optimal Anticoagulation Through Genetics (COAG)* 12,927,382 12,927,382
Pumps for Kids, Infants, and Neonates (PumpKIN)** 1,808,165 1,808,165
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 2,824,999 29,739,314
Women’s Health Initiative (WHI) 815,836,245 21,909,919 837,746,164
Subtotal, Heart and Vascular Diseases  982,889,802 27,516,808 1,010,406,610
Lung Diseases      
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) 83,838,739 4,886,159 88,724,898
Long-Term Oxygen Treatment Trial (LOTT) 25,165,226 7,562,054 32,727,280
Subtotal, Lung Diseases 109,003,965 12,448,213 121,452,178
Blood Diseases and Resources      
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) 22,700,173 8,501,196 31,201,369
Subtotal, Blood Diseases and Resources  22,700,173 8,501,196 31,201,369
Total, NHLBI-Initiated Clinical Trials, Contracts $1,114,593,940 $48,466,217 $1,163,060,157

* Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy.
** See Chapter 10 for preclinical PumpKIN R&D. 

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Cooperative Agreements

 

Total Obligations
Prior to FY 2012
Total FY 2012
Obligations
Total Obligations
to Date
Heart and Vascular Diseases

 

 

 

Cardiovascular Cell Therapy Research Network $28,219,327 $5,783,413 $34,002,740
Childhood Obesity Prevention and Treatment Research (COPTR) 8,044,862 7,527,535  15,572,397
Consortium of Hospitals Advancing Research (CHART)* 6,826,745 4,933,114  11,759,859
Diabetes Prevention Program Outcomes Study—Phase II 3,300,000 2,425,500  5,725,500
Early Adult Reduction of Weight Through LifestYle Intervention (EARLY) Trials** 16,643,216 4,857,967  21,501,183
EDTA Chelation Therapy for Coronary Artery Disease  2,109,044  908,302  3,017,346
Heart Failure Clinical Research Network 44,760,674 6,460,152  51,220,826
Look AHEAD:  Action for Health in Diabetes 12,000,000 4,000,000  16,000,000
Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine 31,438,403 7,097,239  38,535,642
Pediatric Heart Network 76,176,050 12,020,076  88,196,126
Pediatric HIV/AIDS Cohort Study (PHACS):  Data and Operations Center 3,859,021 1,716,153  5,575,174
Resuscitation Outcomes Consortium (ROC) 55,902,830 9,373,746  65,276,576
Subtotal, Heart and Vascular Diseases 233,377,342 57,729,451 291,106,793
Lung Diseases      
Asthma Clinical Research Network (ACRN) 42,901,101 113,804  43,014,905
Asthma Network (AsthmaNet) 39,300,000 16,464,537  55,764,537
Novel Therapies for Lung Diseases—Phase II 20,436,977 15,477,541  35,914,518
Subtotal, Lung Diseases 59,736,977 31,942,078  91,679,055
Blood Diseases and Resources      
Blood and Marrow Transplant Clinical Research Network 64,390,805 4,051,982  68,442,787
Transfusion Medicine/Hemostasis Clinical Research Network 63,173,772 5,902,779  69,076,551
Subtotal, Blood Diseases and Resources 127,564,577 9,954,761 137,519,338
Total, NHLBI-Initiated Clinical Trials, Cooperative Agreements $420,678,896 $99,626,290 $520,305,186
Total, NHLBI-Initiated Clinical Trials $1,535,272,836 $148,092,507 $1,683,365,343

*    Formerly known as Effectiveness Research on Smoking Cessation in Hospitalized Patients. 
**  Formerly known as Targeted Approaches to Weight Control for Young Adults.
     Formerly known as Clinical Research Consortium To Improve Resuscitation Outcomes.

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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 2012—$973,725
Fiscal Years 1993–2011—$85,376,672
Total Funding to Date—$86,350,397

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 2012—$5,783,413
Fiscal Years 2007–2011—$28,219,327
Total Funding to Date—$34,002,740

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
  7. Stanford University
    Menlo Park, California                                    —HL-113456
  8. Indiana University
    Indianapolis, Indiana                                       —HL-113457
  9. University of Miami
    Miami, Florida                                                   —HL-113460
  10. University of Louisville
    Louisville, Kentucky                                         —HL-113530

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 2012—$7,527,535
Fiscal Years 2010–2011—$8,044,862
Total Funding to Date—$15,572,397

Current Active Organizations and Grant Numbers

  1. University of North Carolina, 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

*  Formerly known as Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy. 

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"). 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 2012—$0
Fiscal Years 2008–2011—$12,927,382
Total Funding to Date—$12,927,382

Current Active Organization and Contract Number

  1. University of Pennsylvania
    Philadelphia, Pennsylvania—268200800003C

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

**  Formerly known as Effective Research on Smoking Cessation in Hospitalized Patients. 

The purpose of this study is to evaluate the effectiveness of smoking cessation interventions in hospitalized patients. A network of six projects is assessing the effectiveness and cost effectiveness of smoking cessation interventions that are initiated during hospitalization and continued post-discharge. Participation from minority populations is strong in some of the projects. 

Obligations

Funding History:
Fiscal Year 2012—$4,933,114
Fiscal Years 2010–2011—$6,826,745
Total Funding to Date—$11,759,859

Current Active Organizations and Grant Numbers

  1. University of Michigan
    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 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 is following 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 2012—$2,425,500
Fiscal Years 2009–2011—$3,300,000
Total Funding to Date—$5,725,500

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 Health 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
  16. University of California, San Diego
    La Jolla, California                                           —DK-048339
  17. Albert Einstein College of Medicine
    Bronx, New York                                              —DK-048349
  18. Massachusetts General Hospital
    Boston, Massachusetts                                    —DK-048397
  19. Washington University
    St. Louis, Missouri                                             —DK-048400
  20. University of Pittsburgh
    Pittsburgh, Pennsylvania                                 —DK-048412
  21. University of Miami
    Coral Gables, Florida                                        —DK-048434
  22. Joslin Diabetes Center
    Boston, Massachusetts                                    —DK-048437

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 2012—$4,857,967
Fiscal Years 2009–2011—$16,643,216
Total Funding to Date—$21,501,183

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. 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

EDTA Chelation Therapy for Coronary Artery Disease, Initiated in Fiscal Year 2009

The purpose of this multi-site, randomized trial is to determine the efficacy and safety of EDTA (ethylene diamine tetra-acetic acid) chelation therapy in individuals suffering from coronary artery disease. 

Obligations

Funding History
Fiscal Year 2012—$908,30
Fiscal Years 2009–2011—$2,109,044
Total Funding to Date—$3,017,346

Current Active Organization and Grant Number

  1. Mount Sinai Medical Center
    Miami Beach, Florida—HL-092607

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. The network is developing, coordinating, and conducting multiple collaborative clinical protocols to facilitate application of emerging basic science discoveries into clinical investigations. 

Obligations

Funding History:
Fiscal Year 2012—$6,460,152
Fiscal Years 2006–2011—$44,760,674
Total Funding to Date—$51,220,826

Current Active Organizations and Grant Numbers

  1. Duke University
    Durham, North Carolina—HL-084904
  2. Mayo Clinic College of Medicine
    Rochester, Minnesota                                      —HL-110262
  3. Thomas Jefferson University
    Philadelphia, Pennsylvania                             —HL-110297
  4. Emory University
    Atlanta, Georgia                                                —HL-110302
  5. Washington University
    St. Louis, Missouri                                             —HL-110309
  6. Duke University
    Durham, North Carolina—HL-110312
  7. Cleveland Clinic
    Cleveland, Ohio                                                 —HL-110336
  8. Massachusetts General Hospital
    Boston, Massachusetts                                    —HL-110337
  9. University of Pennsylvania
    Philadelphia, Pennsylvania                             —HL-110338
  10. University of Vermont
    Burlington, Vermont                                         —HL-110342

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

The purpose of this multicenter randomized clinical trial is to determine the long-term effects 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. The lifestyle intervention group is being compared to a control group that is receiving diabetes support and education. One of the 16 clinical centers is targeting American Indians. 

Obligations

Funding History:
Fiscal Year 2012—$4,000,000
Fiscal Years 2009–2011—$12,000,000
Total Funding to Date—$16,000,000

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 2012—$7,097,239
Fiscal Years 2007–2011—$31,438,403
Total Funding to Date—$38,535,642

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 2012—$12,020,076
Fiscal Years 2001–2011—$76,176,050
Total Funding to Date—$88,196,126

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
    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 2012—$1,716,153
Fiscal Years 2006–2011—$3,859,021
Total Funding to Date—$5,575,174

Current Active Organization and Grant Number

  1. Harvard University
    Boston, Massachusetts                                    —HD-052102

Pumps for Kids, Infants, and Neonates (PumpKIN), Initiated in Fiscal Year 2012

The purpose of this program is to explore the potential benefit of therapy offered by four novel pediatric circulatory support devices in infants, neonates, and young children (<25 kg) with congenital and acquired CVD who experience cardiopulmonary failure and circulatory collapse. The trials are intended to provide clinical evidence to be used in Humanitarian Device Exemption applications to the FDA for regulatory approval of the devices. 

Obligations

Funding History:
Fiscal Year 2012—$1,808,165
Total Funding to Date—$1,808,165

Current Active Organization and Contract Number

  1. University of Pittsburgh
    Pittsburgh, PA                                           —268201000013C

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 2012—$0
Fiscal Year 2011—$4,952,781
Total Funding to Date—$4,952,781

Current Active Organization and Contract Number

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

Resuscitation Outcomes Consortium (ROC),* 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 severe trauma. 

Obligations

Funding History:
Fiscal Year 2012—$9,373,746
Fiscal Years 2004–2011—$55,902,830
Total Funding to Date—$65,276,576

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

*  Formerly known as Clinical Research Consortium To Improve Resuscitation Outcomes. 

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 dementia. 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 2012—$0
Fiscal Years 2009–2011—$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           —268200900040C
  2. Case Western Reserve University
    Cleveland, Ohio                                       —268200900046C
  3. University of Alabama at Birmingham
    Birmingham, Alabama                          —268200900047C
  4. Wake Forest University Health
    Science Center
    Winston-Salem, North Carolina           —268200900048C
  5. University of Utah
    Salt Lake City, Utah                               —268200900049C
  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). Recruitment ended in 2012, with 3,445 patients from Argentina, Brazil, Canada, Republic of Georgia, Russia, and the United States. 

Obligations

Funding History:
Fiscal Year 2012—$2,824,999
Fiscal Years 2004–2011—$26,914,315
Total Funding to Date—$29,739,314

Current Active Organizations and Contract Numbers

  1. HHS Program Support Center, Supply
    Service Center
    Perry Point, Maryland—HL-12025
  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 consisted 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 included 161,808 women, 17 percent of whom were 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 2012—$21,909,919
Fiscal Years 1992–2011*—$815,836,945
Total Funding to Date—$837,746,164

*  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

Asthma Clinical Research Network (ACRN), Phase II, Initiated in Fiscal Year 2003

The purpose of this network was to evaluate current and novel therapies and management strategies for adult asthma and to ensure that findings are rapidly disseminated to the medical community. The study has ended. 

Obligations

Funding History:
Fiscal Year 2012—$113,804
Fiscal Years 2003–2011—$42,901,101
Total Funding to Date—$43,014,905

Current Active Organization and Grant Number

  1. University of California, San Diego
    La Jolla, California                                           —HL-074218

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 2012—$4,886,159
Fiscal Years 1994–2011—$83,838,739
Total Funding to Date—$88,724,898

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 to identify optimal therapies for a variety of asthma phenotypes, genotypes, and racial and ethnic backgrounds. Investigators 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 2012—$16,464,537
Fiscal Years 2009–2011—$39,300,000
Total Funding to Date—$55,764,537

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

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. 

Obligations

Funding History:
Fiscal Year 2012—$7,562,054
Fiscal Years 2007–2011—$25,165,226
Total Funding to Date—$32,727,280

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. Los Angeles Biomedical
    Institute/Harbor-UCLA
    Los Angeles, California                                      —HR-76188
  6. Ohio State University
    Columbus, Ohio                                                  —HR-76189
  7. Temple University
    Philadelphia, Pennsylvania                               —HR-76190
  8. University of Alabama at Birmingham
    Birmingham, Alabama                                      —HR-76191
  9. University of Michigan
    Ann Arbor, Michigan                                          —HR-76192
  10. University of Pittsburgh
    Pittsburgh, Pennsylvania                                   —HR-76193
  11. University of Utah
    Salt Lake City, Utah                                           —HR-76194
  12. University of Washington
    Seattle, Washington                                            —HR-76195
  13. Washington University
    St. Louis, Missouri                                               —HR-76196
  14. 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 2012—$15,477,541
Fiscal Years 2010–2011—$20,436,977
Total Funding to Date—$35,914,518

Current Active Organizations and Grant Numbers

  1. Brigham and Women's Hospital
    Boston, Massachusetts                                    —HL-102225
  2. University of Iowa
    Iowa City, Iowa                                                —HL-102288
  3. Fred Hutchinson Cancer Research Center
    Seattle, Washington                                          —HL-102547
  4. University of Wisconsin
    Madison, Wisconsin                                         —HL-105365
  5. Brigham and Women's Hospital
    Boston, Massachusetts                                    —HL-105371
  6. Johns Hopkins University
    Baltimore, Maryland                                        —HL-105569
  7. Mayo Clinic
    Rochester, Minnesota                                      —HL-108712
  8. 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 2012—$4,051,982
Fiscal Years 2001–2011—$64,390,805
Total Funding to Date—$68,442,787

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
    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 2012—$8,501,196
Fiscal Years 2000–2011—$22,700,173
Total Funding to Date—$31,201,369

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

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 2012—$5,902,779
Fiscal Years 2002–2011—$63,173,772
Total Funding to Date—$69,076,551

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. Massachusetts General Hospital
    Boston, Massachusetts                                    —HL-072299
  13. Puget Sound Blood Center
    Seattle, Washington                                          —HL-072305
  14. University of Pittsburgh
    Pittsburgh, Pennsylvania                                 —HL-072331
  15. University of Pennsylvania
    Philadelphia, Pennsylvania                             —HL-072346
  16. University of North Carolina, Chapel Hill
    Chapel Hill, North Carolina                            —HL-072355
  17. University of Maryland
    Baltimore Professional School
    Baltimore, Maryland                                        —HL-072359

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