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The Study on Omega-3 Fatty Acids and Ventricular Arrhythmia (SOFA) Randomized Trial

Ingeborg A. Brouwer, PhD; Peter L. Zock, PhD; A. John Camm, MD, PhD; Dirk Böcker, MD, PhD; Richard N. W. Hauer, MD, PhD; Eric F. D. Wever, MD, PhD; Carla Dullemeijer, MSc; Jacintha E. Ronden, PhD; Martijn B. Katan, PhD; Andrzej Lubinski, MD; Helga Buschler, MD; Evert G. Schouten, MD, PhD; for the SOFA Study Group

JAMA. 2006;295:2613-2619.

Context  Very-long-chain n-3 polyunsaturated fatty acids (omega-3 PUFAs) from fish are thought to reduce risk of sudden death, possibly by reducing susceptibility to cardiac arrhythmia.

Objective  To study the effect of supplemental fish oil vs placebo on ventricular tachyarrhythmia or death.

Design, Setting, and Patients  The Study on Omega-3 Fatty acids and ventricular Arrhythmia (SOFA) was a randomized, parallel, placebo-controlled, double-blind trial conducted at 26 cardiology clinics across Europe. A total of 546 patients with implantable cardioverter-defibrillators (ICDs) and prior documented malignant ventricular tachycardia (VT) or ventricular fibrillation (VF) were enrolled between October 2001 and August 2004. Patients were randomly assigned to receive 2 g/d of fish oil (n = 273) or placebo (n = 273) for a median period of 356 days (range, 14-379 days).

Main Outcome Measure  Appropriate ICD intervention for VT or VF, or all-cause death.

Results  The primary end point occurred in 81 (30%) patients taking fish oil vs 90 (33%) patients taking placebo (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.64-1.16; P = .33). In prespecified subgroup analyses, the HR was 0.91 (95% CI, 0.66-1.26) for fish oil vs placebo in the 411 patients who had experienced VT in the year before the study, and 0.76 (95% CI, 0.52-1.11) for 332 patients with prior myocardial infarctions.

Conclusion  Our findings do not indicate evidence of a strong protective effect of intake of omega-3 PUFAs from fish oil against ventricular arrhythmia in patients with ICDs.

Trial Registration  clinicaltrials.gov Identifier: NCT00110838

Author Affiliations: Wageningen Centre for Food Sciences (Drs Brouwer, Zock, Katan, and Schouten, and Ms Dullemeijer); Division of Human Nutrition, Wageningen University, Wageningen, the Netherlands (Drs Brouwer, Zock, Katan, and Schouten and Ms Dullemeijer); Department of Cardiological Sciences, St George's Hospital and Medical School, London, England (Dr Camm); Department of Cardiology, Universitätsklinikum Münster, Germany (Dr Böcker); Department of Cardiology, Heart Lung Centre Utrecht, the Netherlands (Drs Hauer and Wever); Cardialysis BV, Rotterdam, the Netherlands (Dr Ronden); Department of Cardiovascular Diseases, Medical University of Gdansk, Gdansk, Poland (Dr Lubinski); and Department of Cardiology, Herz-und Diabeteszentrum Bad Oeynhausen, Germany (Dr Buschler).

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