SOFA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia

Phase 3

Completed

• Conditions: Arrhythmia

• Registration Number: NCT00110838
• Lead Sponsor: Wageningen Centre for Food Sciences

Brief Summary

The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).

Detailed Description

Previous human observational studies and clinical trials provide strong indications that n-3 PUFA from fish can prevent cardiovascular disease. Striking is that these studies show a strong relation between n-3 PUFA and sudden death, but not between n-3 PUFA and non-fatal heart disease. Sudden death is one of the most common and often the first manifestation of coronary heart disease. The majority of sudden deaths are directly caused by acute ventricular arrhythmia. Our hypothesis is that n-3 PUFA prevents sudden death by suppressing life-threatening cardiac arrhythmia. Therefore, we investigate in a randomized controlled clinical trial whether supplemental intake of n-3 PUFA from fish can reduce the incidence of life-threatening cardiac arrhythmias. Our population consists of patients with an implantable cardioverter defibrillator (ICD), because this device records all arrhythmic events in a memory chip. As the ICD enables continuous monitoring of events in nonhospitalised patients, this population is very suitable for testing a possible antiarrhythmic effect of n-3 PUFA. The objective of the SOFA trial is to investigate the effect of fish oil on the incidence of recurrent ventricular arrhythmia in patients with an ICD. The SOFA is a randomised, parallel, placebo-controlled, double-blind intervention study which is currently being carried out in 26 cardiology centers in Europe. Five hundred forty six patients with an ICD are randomised to receive either 2g/d of fish oil or placebo oil for a period up to 12 months. The primary outcome is spontaneous ventricular tachyarrhythmias as detected by the ICD or all-cause mortality within 12 months.

Study Timeline

• Study Start: 2001-10
• Study Completion: 2005-01
• Status Verified: 2005-05
• Study First Submitted: 2005-05-13
• Study First Submitted QC: 2005-05-13
• Study First Posted: 2005-05-16
• Last Update Submitted: 2006-07-20
• Last Update Posted: 2006-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 546

Inclusion Criteria

• ICD is capable of recording ECG strips for at least 10 of its (attempted) therapeutic interventions
• 18 years or older
• written informed consent

Exclusion Criteria

• Primary prophylactic indication
• ICD implantation as a 'bridge' to heart transplantation
• Refractory supraventricular arrhythmias with rapid ventricular rates despite antiarrhythmic therapy
• a projected lifespan of less than 1 year
• participation in another trial (during or within 30 days before SOFA)
• use of any supplemental n-3 fatty acid during the last 3 months
• intake of more than 8g of n-3 fatty acids from fish per month as judged by a fish frequency questionnaire
• pregnant women and women of childbearing potential who do not use adequate contraception
• patients known to have a history of recent drug or alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality

Secondary Outcome Measures

Name	Time	Method
All cause mortality (separately from ventricular tachyarrhythmia)
Cardiac mortality
Myocardial infarction
All arrhythmic events as documented by the ICD Core laboratory
Change in the prescription of antiarrhythmic drugs

Trial Locations

Locations (27)

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Germany

Wageningen Centre for Food Sciences; 🇳🇱 Wageningen, Netherlands

Klinikum Benjamin Franklin Berlin; 🇩🇪 Berlin, Germany

Klinikum der Friedrich-Schiller-Universitat; 🇩🇪 Jena, Germany

Stiftsklinik Augustinum; 🇩🇪 Munich, Germany

University Medical Center Rotterdam Erasmus; 🇳🇱 Rotterdam, Netherlands

Isala Klinieken (Locatie Wezenlanden); 🇳🇱 Zwolle, Netherlands

Medical University of Gdansk; 🇵🇱 Gdansk, Poland

I Klinika Kardiologii; 🇵🇱 Katowice, Poland

Pomeranian Academy of Medicine; 🇵🇱 Szczecin, Poland

Instytut Kardiologii; 🇵🇱 Warsaw, Poland

Grochowski Hospital; 🇵🇱 Warsaw, Poland

Centre Hospitalier Universitaire Voudois; 🇨🇭 Lausanne, Switzerland

Wilhelminenspital; 🇦🇹 Vienna, Austria

Herz- und Diabeteszentrum Nordrhein-Westfalen; 🇩🇪 Bad Oeynhausen, Germany

University Medical Centre Utrecht; 🇳🇱 Utrecht, Netherlands

St George Hospital Medical School; 🇬🇧 London, United Kingdom

Interni Kardiologicka Klinika; 🇨🇿 Brno, Czech Republic

Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom

St. Antoniusziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Institute of Clinical and Experimental Medicine; 🇨🇿 Prague, Czech Republic

Academic Medical Centre Amsterdam; 🇳🇱 Amsterdam, Netherlands

Universitatsklinikum Muenster; 🇩🇪 Muenster, Germany

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany