Defibrillators in nonischemic cardiomyopathy treatment evaluation

Abstract

The Defibrillotars in Nonischemic Cardiomyopathy Treatment Evaluation (DEFINITE) is a multicenter randomized trial. Patients will have nonischemic cardiomyopathy (LVEF ≤ 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 Halter 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 β-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.