In 2003, our Clinical Trials Department provided short-term recruitment support for several trials, large and small, throughout the year including Mirabelle and NAVIGATOR. The ABC continues its extended support on a number of other trials, including the following:
1) African American Heart Failure Trial (A-HeFT)
Anne Taylor, M.D. (Principal Investigator)
A randomized controlled clinical trial to assess the safety and efficacy of a vasodilator combination (BiDil) consisting of hydralizine plus isosobide dinitrate in African American patients with NYHA class III-IV heart failure while on standard therapy including ACE-I, digitalis, diuretic, and beta blockers.
As a co-sponsor of A-HeFT, the ABC is committed to ensuring the success of this trial. ABC members serve on the Steering Committee, End Point Committee, and Data Safety Monitoring Board (DSMB).
2) Home AED Trial (HAT)
Gust Brady, M.D. (Principal Investigator)
An NIH-funded randomized, controlled clinical trial to evaluate the impact of adding the use of a home automatic external defibrillator (AED) to the standard lay response to sudden cardiac arrest (call EMS/CPR) on all cause mortality based on a minimum of two years of follow-up.
As a partner of HAT, the ABC is committed to ensuring the recruitment of African American patients as well as the success of this trial. ABC members serve on the Steering Committee.
3) ARIES
Keith Ferdinand, M.D. (Principal Investigator)
A six-week Randomized Open-label Comparative Study to Evaluate the Safety and Efficacy of Rosuvastation versus Atorvastatin in the Treatment of Hypercholesterolemia in African American Subjects
Patient enrollment concluded in 2003. ABC members represented 41% of the investigator pool and randomized 48% of the patients.
