Heart Diseases Clinical Trial
To determine if the dietary N-3 class of polyunsaturated fatty acids (PUFAs) provided in the diet largely from marine fish oils would prevent fatal ventricular tachycardia (VT) or ventricular fibrillation (VF).
BACKGROUND:
Sudden death is a common manifestation of ischemic heart disease and therefore of great
public health concern. Unfortunately several promising antiarrhythmic drugs proved not to be
effective in preventing sudden deaths. This project would test whether a relatively
inexpensive and presumably innocuous therapy, fish oil supplements, can prevent
life-threatening arrhythmias. There is ample basic evidence that n-3 fatty acids contained
in fish oil supplements may suppress arrhythmias, and a clinical trial seems warranted.
DESIGN NARRATIVE:
Prospective, randomized, placebo-controlled, double-blind. Patients were randomized to 4
grams per day of a PUFA fish oil supplement versus an olive oil placebo. The number of
therapeutic discharges were recorded from the ICDs and then confirmed from the recorded
electrocardiogram strips with the kinds of arrhythmias which had induced the ICD response.
The primary end point, time to first ICD event for ventricular tachycardia or fibrillation
(VT or VF) confirmed by stored electrograms or death from any cause, was analyzed by
intention to treat.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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