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.