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

NCT ID: NCT00110838

Last Updated: 2006-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2005-01-31

Brief Summary

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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

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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.

Conditions

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Arrhythmia

Keywords

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fish oil n-3 fatty acids n-3 PUFA omega-3 fatty acids arrhythmia ICD human Patients with an implantable cardioverter defibrillator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Supplementation with fish oil versus placebo

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SEAFOODplus

OTHER

Sponsor Role collaborator

Wageningen Centre for Food Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Evert G Schouten, MD, PhD

Role: STUDY_CHAIR

Wageningen Centre for Food Sciences

Locations

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Wilhelminenspital

Vienna, , Austria

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

Interni Kardiologicka Klinika

Brno, , Czechia

Site Status

Institute of Clinical and Experimental Medicine

Prague, , Czechia

Site Status

Kerckhoff-Klinik GmbH

Bad Nauheim, , Germany

Site Status

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, , Germany

Site Status

Klinikum Benjamin Franklin Berlin

Berlin, , Germany

Site Status

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Klinikum der Friedrich-Schiller-Universitat

Jena, , Germany

Site Status

Stiftsklinik Augustinum

Munich, , Germany

Site Status

Universitatsklinikum Muenster

Münster, , Germany

Site Status

Academic Medical Centre Amsterdam

Amsterdam, , Netherlands

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

St. Antoniusziekenhuis

Nieuwegein, , Netherlands

Site Status

University Medical Center Rotterdam Erasmus

Rotterdam, , Netherlands

Site Status

University Medical Centre Utrecht

Utrecht, , Netherlands

Site Status

Wageningen Centre for Food Sciences

Wageningen, , Netherlands

Site Status

Isala Klinieken (Locatie Wezenlanden)

Zwolle, , Netherlands

Site Status

Medical University of Gdansk

Gdansk, , Poland

Site Status

I Klinika Kardiologii

Katowice, , Poland

Site Status

Pomeranian Academy of Medicine

Szczecin, , Poland

Site Status

Instytut Kardiologii

Warsaw, , Poland

Site Status

Grochowski Hospital

Warsaw, , Poland

Site Status

Centre Hospitalier Universitaire Voudois

Lausanne, , Switzerland

Site Status

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

St George Hospital Medical School

London, , United Kingdom

Site Status

Southampton General Hospital

Southampton, , United Kingdom

Site Status

Countries

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Austria Belgium Czechia Germany Netherlands Poland Switzerland United Kingdom

References

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Brouwer IA, Zock PL, Wever EF, Hauer RN, Camm AJ, Bocker 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. doi: 10.1038/sj.ejcn.1601695.

Reference Type BACKGROUND
PMID: 14506496 (View on PubMed)

Brouwer IA, Zock PL, Camm AJ, Bocker 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 defibrillators: the Study on Omega-3 Fatty Acids and Ventricular Arrhythmia (SOFA) randomized trial. JAMA. 2006 Jun 14;295(22):2613-9. doi: 10.1001/jama.295.22.2613.

Reference Type RESULT
PMID: 16772624 (View on PubMed)

Other Identifiers

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TME/C-01.07

Identifier Type: -

Identifier Source: org_study_id