Sudden Cardiac Death in Heart Failure Trial

Congestive heart failure (CHF) is a common and lethal disease. A new diagnosis of CHF is made in over 400,000 North Americans each year. Those with moderate left ventricular dysfunction have a death rate of 25% over 2 1/2 years, with 50% of those deaths thought to be due to arrhythmias. The central hypothesis of this study is that amiodarone or an implantable cardioverter-defibrillator (ICD) will improve survival compared to placebo in patients with NYHA Class II and Class III CHF and reduced left ventricular ejection fraction <35%. This study is sponsored by the NHLBI, Medtronic, Inc., and Wyeth-Ayerst Laboratories.

The study will be a prospective, clinical trial with 2,500 patients randomly allocated in equal proportions to three different treatment arms over 2 1/2 years. The first arm of the study will consist of conventional heart failure therapy and placebo. The second arm of the study will combine conventional therapy with amiodarone. The third arm of the study will employ conventional therapy with a pectoral ICD. Treatment arms will be compared using an intention-to-treat analysis.

The trial will be performed at over 100 North American Institutions. The Clinical Coordinating Center is at the Seattle Institute for Cardiac Research (SICR) in Seattle, Washington. The Data Coordinating Center and the Economics and Quality of Life Coordinating Center are at Duke University in Durham, North Carolina. The ICD Memory Log Core Laboratory, located at SICR, is a subunit of the Clinical Coordinating Center focusing on ICD memory analysis.