Innovation requires both an expectation of frequent failure (trial and error) and a longer view.
In March 2001, the Food and Drug Administration allowed the testing of a drug called BiDil in about 600 black subjects who will participate in the African-American Heart Failure Trial, the largest clinical trial ever to focus exclusively on African-Americans.
The rationale and design of the Surgical Treatment for Ischemic Heart Failure trial is described.
The REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial entailed the scientific confirmation of that benefit and other later studies support it.
Methods and Results: The African-American Heart Failure Trial (A-HeFT) is double-blind, placebo-controlled, and includes African American patients with stable New York Heart Association Class III-IV HF on standard therapy.
The Valsartan Heart Failure Trial was designed to determine whether addition of valsartan improved the outcomes of patients receiving standard therapy for heart failure, which in most cases included an ACE inhibitor.
Before the Surgical Treatment for Ischemic Heart Failure trial, less than 1000 patients with ischemic cardiomyopathy had been studied in randomized comparisons of medical therapy versus coronary artery bypass grafting.
This observation led to the design of the African American Heart Failure Trial (A-HeFT), which confirmed the benefit of these drugs in combination in African American patients with CHF.
In patients with heart failure and atrial fibrillation, the AF-CHF (Atrial Fibrillation and Congestive Heart Failure) trial did not demonstrate the superiority of rhythm control (RhyC) over a rate control (RaC) strategy on cardiovascular mortality.
It was internally validated with bootstrapping (c-index = 0.75, chi-square = 1,220.8) and externally validated in patients with ischemic cardiomyopathy from the Sudden Cardiac Death Heart Failure Trial (SCD-HeFT) database (c-index = 0.64, chi-square = 14.1).
The randomized MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial established that DDDRP + MVP pacing modality reduced permanent AF in bradycardia patients as compared with standard dual-chamber pacing (DDDR).
