Defibrillators in nonischemic cardiomyopathy treatment evaluation

The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation (DEFINITE) is a multicenter randomized trial. Patients will have nonischemic cardiomyopathy (LVEF < or = 35%), a history of symptomatic heart failure and spontaneous arrhythmia (> 10 PVCs/hour or nonsustained ventricular tachycardia defined as 3-15 beats at a rate of > 120 beats/min) on Holter monitor or telemetry within the past 6 months. Patients will be randomized to an implantable cardioverter defibrillator (ICD) versus no ICD. All patients will receive standard oral medical therapy for heart failure including angiotensin converting enzyme inhibitors and beta-blockers (if tolerated). Patients will be followed for 2-3 years. The primary endpoint will be total mortality. Quality-of-life and pharmacoeconomics analyses will also be performed. A registry will track patients who meet basic inclusion criteria 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 expected to reduce mortality by 50%. Approximately 204 patients will be required in each treatment group. Twenty-five centers will be included in a trial designed to last an estimated 4 years.