Title of Trial
The Sudden Cardiac Death in Heart Failure Trial

Date and Location of Presentation
March 8, 2004, American College of Cardiology Scientific Sessions

Date and Citation of Primary Publication(s) or References
www.sicr.org

Purpose of the Trial
To determine if amiodarone or ICD improves survival in patients with non-ischemic or ischemic NYHA Class II and III heart failure and ejection fraction less than or equal to 35%.

Study Categories
ICD and Sudden Cardiac Death

Patient Population
Patients with heart failure

Inclusion Criteria
NYHA Class II or III, EF < 0.35

Exclusion Criteria
N/A

Study Design
Randomized multicenter trial. Randomization to 1) Placebo, 2) Amiodarone <800 mg/d wk1, <400 mg/d wk 2-4, chronic 200 mg/d <150 lbs, 300 mg/d 150-200 lbs, 400 mg/d >200lbs , 3) VVI-ICD

Primary Endpoint(s)
All-cause mortality

Secondary Endpoint(s)
N/A

Baseline Characteristics
Patient number: 2,521
Mean Age: 60.1 years
Gender: 23% Female

Follow-up: 3.8 years

Results
23% reduction in all-cause mortality in patients receiving ICD compared to placebo. Hazard ratio: 0.77 (p = 0.007); Hazard ratios: 0.54 Class II, 1.16 Class III; ischemic 0.79, non-ischemic 0.73. No difference in survival in patients treated with amiodarone compared to placebo.

Sponsor
National Institutes of Health; Wyeth-Ayerst, Medtronic

Trial Status: Completed

Review written by Paul J. Wang, MD