Patient Populations:

1) 18 years of age or older.
2) Heart failure for at least 3 months and treated with a vasodilator.
3) Symptomatic CHF (NYHA class II and III) due to ischemic or nonischemic dilated cardiomyopathy.
4) LVEF ≤35% within 3 months of enrollment.
5) All patients are requested, but not required, to have had a coronary angiogram to document the nature of their disease. The definition of ischemic cardiomyopathy will be systolic LV dysfunction in the presence of ≤75% luminal coronary artery or insignificant coronary artery disease with definitive evidence of myocardial infarction (MI).
6) Patients with chronic atrial fibrillation must be anticoagulated with warfarin, with documented international normalized ratios of at least 2.0 for ≥21 days prior to randomization.

Exclusions:

1) Symptomatic ventricular arrhythmias.
2) LVEF >35% or asymptomatic LV dysfunction.
3) NYHA class IV CHF.
4) History of cardiac arrest or a spontaneous episode of sustained ventricular tachycardia (VT) (≥30 seconds at rates of >100 bpm) not associated with an acute Q-wave MI. (Sustained VT or an aborted cardiac arrest within 48 hours of an MI is not an exclusion criterion).
5) Any noncardiac disease that may cause death within 12 months.
6) Females who are pregnant or have childbearing potential and are not using reliable methods of contraception.
7) History of restrictive, infiltrative, or hypertrophic cardiomyopathy; constrictive pericarditis; acute myocarditis; congenital heart disease; surgically correctable valvular disease; and/or inoperable obstructive valvular disease.
8) History of mechanical prosthetic cardiac valves.
9) History of a major psychiatric disorder, active alcohol/drug abuse, or noncompliance.
10) Contraindication for taking amiodarone for any reason or currently taking amiodarone.
11) Indication for antiarrhythmic drugs.
12) Atrial fibrillation requiring catheter ablation of the atrioventricular conduction system or amiodarone for rate control.
13) Unexplained syncope within the last five years.
14) Patients unable to accommodate ICD placement in the left infraclavicular region.
15) Expected to undergo cardiac transplantation within 12 months.
16) Permanent pacemaker.
17) Liver function tests (>2.5 times normal or a serum creatinine >2.5 mg/dl).
18) Currently receiving antibiotics.

Primary Endpoints:

All-cause mortality

Secondary Endpoints:

1) Arrhythmic cardiac mortality.
2) Nonarrhythmic cardiac mortality.
3) Composite of all-cause mortality and rehospitalization for CHF.
4) Health-related quality of life.
5) Cost of care and calculate incremental cost-effectiveness ratios.

Drug/Procedures Used:

Patients were randomized in a double-blind manner to either: 1) Conventional CHF therapy and placebo, 2) conventional CHF therapy plus amiodarone, or 3) conventional CHF therapy plus a conservatively programmed single lead ICD. Amiodarone was dosed at 800 mg during the first week, 400 mg during weeks 2-4, and chronically at 200 mg/day if <150 lbs, 300 mg/day if 150-200 lbs, and 400 mg/day if >200 lbs.

ICDs were programmed for ventricular fibrillation (VF) treatment only. Patients underwent a six-minute walk test and Holter monitoring.