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List of Major Studies    
FLuctuATion reduction with inSUlin and Glp-1 Added together (FLAT-SUGAR)
A clinical trial to compare basal insulin plus the addition of the GLP-1 analogue, exenatide, with basal insulin plus the addition of prandial insulin (insulin glulisine) on glycemic variability in 130 diabetic patients in 12 centers;
Sponsored by Sanofi-Aventis;
2011-2013 ($822,527).
 

ALLHAT Phase 3 - Continuation and Outreach
ALLHAT Phase 3 - Continuation and Outreach

To facilitate and encourage use of ALLHAT’s dataset by outside investigators, the National Heart, Lung, and Blood Institute has funded a new phase entitled ALLHAT Continuation and Outreach. Its purposes are to:

  1. develop processes that assure optimal scientific contributions, build on to-date publications and explore new areas, in part through involving appropriate consultants as leaders of relevant scientific areas;
  2. encourage productive interdisciplinary collaboration and mentor early-stage investigators from a diverse set of institutions, especially investigators with no recent history of participating in ALLHAT; and
  3. promote awareness of the ALLHAT resources among research and clinical communities.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI)
2011-
 
Trans-Cranial Doppler (TCD) With Transfusions Changing to Hydroxyurea
Arandomized controlled clinical trial to compare standard therapy (erythrocyte transfusions) with alternative therapy (hydroxyurea) for the maintenance of lowered TCD velocities in 118 pediatric subjects with sickle cell anemia and abnormal pre-treatment TCD velocities in 26 centers.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI);
2010-2014 ($3,377,396).
 
Cardiovascular Cell Therapy Research Network (CCTRN) – Data Coordinatng Center
The CCTRN is a cooperative clinical network consisting of five clinical centers in the United States dedicated to studying autologous stem cell therapy for the treatment of cardiovascular disease. The Network includes expert researchers with experience in cardiovascular care at five stem cell centers in the United States. CCTRN is currently planning and conducting multicenter study phase II clinical trials.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI);
2007-2011 ($17,479,247).
 

Post Trial Followup
POST-TRIAL Follow-up of ALLHAT
Active follow-up of ALLHAT participants ended on March 31, 2002 (February 15, 2000 for doxazosin participants), for an average follow-up of 4.9 years (3.2 years for doxazosin). To answer additional scientific questions, a post-trial follow-up of participants through 2006 is planned to obtain data on post-trial morbidity and mortality. The extended follow-up will be carried out passively using national databases available through the National Death Index (NDI), Social Security Administration (SSA), Centers for Medicare and Medicaid Services (CMS), Department of Veterans Affairs (DVA), and United States Renal Data System (USRDS). When completed, endpoint data will be available for between 9 and 10 years of total follow-up.
The overall research objective of this extended follow-up is to compare long-term effects of antihypertensive treatment with a thiazide-type diuretic, a CCB, an ACE-inhibitor, or an a-receptor blocker when each drug is 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. To meet these objectives, we will evaluate whether new differences emerge for outcomes that were not statistically different, especially CVD and total mortality, and whether the differences observed during the trial continue.
The ALLHAT extension protocol was developed by the CTC and the NHLBI Project Office and approved by the ALLHAT Steering Committee.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI)
2002-2006
 
Specialized Program of Translational Research in Acute Stroke (SPOTRIAS)
A specialized center program of four phase I and II clinical trials and one epidemiological study. The goal of SPOTRIAS is to reduce disability and mortality in acute stroke patients through the development of improved treatment by laboratory investigation into the biology of stroke, clinical investigation of new therapies based on these laboratory studies, and assessment of outcome and improved application of effective therapies. Secure web applications update the SPOTRIAS database.
Sponsored by the National Institute of Neurological Disorders and Stroke (NINDS);
2002-2007 ($640,877).
 
Genetics of Hypertension Associated Treatments (GENHAT)
A prospective study that examines the association between selected hypertensive genes and coronary heart diseases modified by the type of antihypertensive treatment. GENHAT is an ancillary study of ALLHAT(see below).
Sponsored by the National Heart, Lung, and Blood Institute (NHLBI);
1999-2004 ($1,474,101).
 
Early Treatment for Retinopathy of Prematurity (ETROP)
ETROP is a multicenter study in 26 centers with a natural history study that is determining the incidence of retinopathy of prematurity and a randomized clinical trial that is determining the safety and efficacy of early treatment of retinopathy of prematurity in 400 premature infants.
Sponsored by the National Eye Institute (NEI);
1999-2009 ($18,405,455).
 
Light Reduction in Prevention of Retinopathy of Prematurity (LIGHT-ROP)
A randomized, multicenter clinical trial in three centers that determined the efficacy of reduced ambient-light exposure to reduce the incidence of retinopathy of prematurity in 409 premature infants.
Sponsored by the National Eye Institute (NEI);
1995-2000 ($441,535).
 
Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial

A practice-based randomized clinical trial of antihypertensive pharmacological treatment in more than 600 office-based practices and general medical and specialty clinics in the U.S., Puerto Rico, the Virgin Islands, and Canada. It had two components:

  • An antihypertensive component, to determine whether newer antihypertensive agents, such as ACE inhibitors, calcium blockers, and alpha blockers, reduce incidence of coronary heart disease (CHD) in high-risk hypertensives when compared to diuretics.
  • A lipid-lowering component, to determine whether reduction of serum cholesterol with pravastatin, an HMG-CoA reductase inhibitor, reduces total mortality in moderately hypercholesterolemic older hypertensives.
A total of 42,418 patients were enrolled between February 23, 1994 and January 31, 1998. A vanguard phase was conducted in the first half of 1994; the full-scale trial began in the fall of 1994 and continued for eight years, until March 31, 2002. The last participant visit was March 31, 2002. The results of the trial were released December 17, 2002.
ALLHAT continues to analyze data for presentations and publications on secondary outcomes, outcomes in subgroups, and other topics for both the antihypertensive component and the lipid-lowering component of the trial. There is also an ongoing Dissemination effort to reach physicians, patients, and formulary benefits managers with the core messages of ALLHAT and the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7).
National Heart, Lung and Blood Institute (NHLBI)
 1993-2008 ($101,198,107).
 
Nitro-Dur in Post Myocardial Infarction Patients (NITRO-DUR)
A randomized, double-blind, placebo-controlled, multicenter clinical trial in 30 centers that tested the effectiveness of intermittent transdermal nitroglycerin therapy on left ventricular dilatation and function in 300 post-myocardio infarction patients.
Sponsored by Schering-Plough, Inc.;
1992-1994 ($310,778).
 
Cholesterol and Recurrent Events Trial (CARE)
A randomized, placebo-controlled, multicenter clinical trial in 80 centers that tested the effectiveness of pravastatin in reducing cardiovascular events in 4,159 post-mycardial infarction patients.
Sponsored by Bristol-Myers-Squibb, Inc.;
1989-2002 ($4,319,394).
 
Survival and Ventricular Enlargement Study (SAVE)
A randomized, placebo-controlled, multicenter clinical trial in 40 centers that tested the effectiveness of captopril in reducing total mortality and/or ventricular enlargement in 2,231 post-myocardial infarction patients.
Sponsored by Bristol-Myers-Squibb, Inc.;
1986-1993 ($1,959,014).
 
Cryotherapy for Retinopathy of Prematurity Study (CRYO-ROP)
A randomized multicenter study in 23 centers enrolling 4,099 infants in a natural history study with a randomized clinical trial that determined the safety and efficacy of cryotherapy of the retina in the treatment of retinopathy of prematurity in 291 premature infants.
Sponsored by the National Eye Institute (NEI) ;
1985-2003 ($4,534,242).
 
Beta-Blocker Heart Attack Trial (BHAT)
A randomized, double-blind, multicenter clinical trial designed to test the effectiveness of propranolol in reducing mortality in 3,837 post-myocardial infarction patients in 31 centers.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI); 1984-1993 ($4,208,443).
1984-1993 ($4,208,443).
 
Systolic Hypertension in the Elderly Program (SHEP)
A randomized, multicenter clinical trial in 16 centers which tested the effectiveness of antihypertensive treatment in reducing the combined incidence of fatal and nonfatal stroke in 4,736 elderly patients with isolated systolic hypertension.
Sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and National Institute on Aging (NIA);
1984-1993 ($9,003,630).
 
Trial of Antihypertensive Interventions and Management (TAIM)
A three-center study of the effectiveness of dietary and pharmacological measures in treating 878 mild hypertensive patients.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI) ;
1984-1993 ($1,058,316).
 
Dietary Intervention Study in Hypertension (DISH)
A three-center study of the effectiveness of dietary measures in helping 479 previously treated HDFP participants remain off drug therapy.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI);
1980-1984 ($421,871).
 
Impact of Hypertension Information (IHI)
A three-center, cross-sectional study of the impact of information about high blood pressure on detection, awareness, and treatment of hypertension in three communities where HDFPclinical centers were located.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI)
1977-1978 (funded in HDFP).
 
Hypertension Incidence Study (HIS)
A three-center, cross-sectional study of the impact of information about high blood pressure on detection, awareness, and treatment of hypertension in three communities where HDFPclinical centers were located.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI);
1977-1978 (funded in HDFP).
 
Hypertension Detection and Follow-up Program (HDFP)
A clinical trial in 14 centers which investigated the differences in mortality and selected morbidity between 10,940 patients randomly allocated to either an intensive hypertension control program or referral back to the regular medical care system.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI);
1971-1993 ($18,059,234).
 
     
  Coordinating Center for Clinical Trials
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