Defibrillators in nonischemic cardiomyopathy treatment evaluation

The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation (DEFI NITE) is a multicenter randomized trial, Patients will have nonischemic car diomyopathy (LVEF less than or equal to 35%), a history of symptomatic hear t failure and spontaneous arrhythmia (> 10 PVCs/hour or nonsustained ventri cular tachycardia defined as 3-15 beats at a rate of > 120 beats/min) on Ho lter monitor or telemetry within the past 6 months. Patients will be random ized to an implantable cardioverter defibrillator (ICD) versus no ICD. All patients will receive standard oral medical therapy for heart failure inclu ding angiotensin converting enzyme inhibitors and beta-blockers (if tolerat ed). Patients will be followed for 2-3 years. The primary endpoint will be total mortality. Qualify-of-life and pharmacoeconomics analyses will also b e performed. A registry will track patients who meet basic inclusion criter ia but are not randomized. We estimate an annual total mortality of 15% at 2 years in the treatment arm that does not receive an ICD. The ICD is expec ted to reduce mortality by 50%. Approximately 204 patients will be required in each treatment group. Twenty-five centers will be included in a trial d esigned to last an estimated 4 years.