Title of Trial
Omega-3 Fatty Acid Therapy in Patients With Ventricular Tachyarrhythmias (OMEGA trial)
Date and Location of Presentation
Presented at the November 2003 American Heart Association Annual Scientific Sessions in Orlando, Florida
Purpose of the Trial
The aim of the OMEGA trial was to assess the effect of treatment with omega-3 polyunsaturated fatty acid therapy (fish oil) compared with placebo on the time to ventricular tachycardia (VT) or ventricular fibrillation (VF) in patients with ventricular tachyarrhythmias and an implantable cardioverer defibrillator (ICD).
Study Category
Sudden Cardiac Death & Syncope
Patient Population
Patients with ICD for sustained VT or VF
Inclusion Criteria
- Patients with a new ICD implanted for sustained VT/VF
- Patients with a previously implanted ICD who had received a shock for VT/VF in the prior 3 months
Exclusion Criteria
- Unable or unwilling to provide written informed consent
Study Design
Double-blinded, placebo-controlled, randomized trial of fish oil (1.8g/d in 2 capsules) versus placebo (olive oil in 2 capsules)
Primary Endpoints
Secondary Endpoints
- Time to recurrent VT/VF
- Time to first VT/VF by subgroup of patients enrolled due to VT or VF
Baseline Characteristics
Patient number: 200 patients
Mean Age: 63 years
Gender: % female; 14%
Other characteristics: Mean baseline left ventricular ejection fraction of 0.35-0.36
Time to Follow-up
2 years
Results
There was no difference in the primary endpoint of time to first VT or VF between the fish oil group and placebo (p=0.19), but contrary to the hypothesis, there was a trend toward an increase in ventricular arrhythmias in the fish oil arm. At 6 months, 47% of patients in the fish oil arm and 36% in the placebo arm had experienced VT or VF; by two years, the rates were 66% and 60%, respectively. In the subgroup of patients enrolled because of VT, the time to first VT/VF occurred earlier in the fish oil arm compared to placebo (p=0.007). In the subgroup of patients enrolled because of VF there was no difference in the time to first VT/VF by treatment group (p=0.38). Recurrent episodes of VT/VF occurred significantly more frequently in the fish oil arm versus placebo (p<0.01). There was a trend towards lower mortality in the fish oil arm (p=0.09), but mortality was not a prespecified endpoint and the study was not powered to detect a difference in clinical events.
Trial Status: Completed
Review written by Samir Saba, MD
