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

Arrhythmia Clinical Trial

Official title:

Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110838
• Other study ID #: TME/C-01.07
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2005
• Last updated: July 20, 2006
• Start date: October 2001
• Est. completion date: January 2005

Study information

• Verified date: May 2005
• Source: Wageningen Centre for Food Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Procedure:
• Supplementation with fish oil versus placebo

Locations

Country	Name	City	State
Austria	Wilhelminenspital	Vienna
Belgium	Universitair Ziekenhuis Gent	Gent
Czech Republic	Interni Kardiologicka Klinika	Brno
Czech Republic	Institute of Clinical and Experimental Medicine	Prague
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Herz- und Diabeteszentrum Nordrhein-Westfalen	Bad Oeynhausen
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Klinikum Benjamin Franklin Berlin	Berlin
Germany	Klinikum der Friedrich-Schiller-Universitat	Jena
Germany	Universitatsklinikum Muenster	Muenster
Germany	Stiftsklinik Augustinum	Munich
Netherlands	Academic Medical Centre Amsterdam	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	St. Antoniusziekenhuis	Nieuwegein
Netherlands	University Medical Center Rotterdam Erasmus	Rotterdam
Netherlands	University Medical Centre Utrecht	Utrecht
Netherlands	Wageningen Centre for Food Sciences	Wageningen
Netherlands	Isala Klinieken (Locatie Wezenlanden)	Zwolle
Poland	Medical University of Gdansk	Gdansk
Poland	I Klinika Kardiologii	Katowice
Poland	Pomeranian Academy of Medicine	Szczecin
Poland	Grochowski Hospital	Warsaw
Poland	Instytut Kardiologii	Warsaw
Switzerland	Centre Hospitalier Universitaire Voudois	Lausanne
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	St George Hospital Medical School	London
United Kingdom	Southampton General Hospital	Southampton

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen Centre for Food Sciences	SEAFOODplus

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Germany,  Netherlands,  Poland,  Switzerland,  United Kingdom, 

References & Publications (2)

Brouwer IA, Zock PL, Camm AJ, Böcker D, Hauer RN, Wever EF, Dullemeijer C, Ronden JE, Katan MB, Lubinski A, Buschler H, Schouten EG; SOFA Study Group. Effect of fish oil on ventricular tachyarrhythmia and death in patients with implantable cardioverter de — View Citation

Brouwer IA, Zock PL, Wever EF, Hauer RN, Camm AJ, Böcker D, Otto-Terlouw P, Katan MB, Schouten EG. Rationale and design of a randomised controlled clinical trial on supplemental intake of n-3 fatty acids and incidence of cardiac arrhythmia: SOFA. Eur J Clin Nutr. 2003 Oct;57(10):1323-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
Secondary	All cause mortality (separately from ventricular tachyarrhythmia)
Secondary	Cardiac mortality
Secondary	Myocardial infarction
Secondary	All arrhythmic events as documented by the ICD Core laboratory
Secondary	Change in the prescription of antiarrhythmic drugs