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

July 20, 2006 updated by: Wageningen Centre for Food Sciences

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

546

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1160
        • Wilhelminenspital
  • Belgium
      • Gent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
  • Czech Republic
      • Brno, Czech Republic, 63900
        • Interni Kardiologicka Klinika
      • Prague, Czech Republic, 14021
        • Institute of Clinical and Experimental Medicine
  • Germany
      • Bad Nauheim, Germany, D-61231
        • Kerckhoff-Klinik GmbH
      • Bad Oeynhausen, Germany, D-32545
        • Herz- und Diabeteszentrum Nordrhein-Westfalen
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 12200
        • Klinikum Benjamin Franklin Berlin
      • Jena, Germany, D-07747
        • Klinikum der Friedrich-Schiller-Universitat
      • Muenster, Germany, 48149
        • Universitätsklinikum Muenster
      • Munich, Germany, 81375
        • Stiftsklinik Augustinum
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Centre Amsterdam
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antoniusziekenhuis
      • Rotterdam, Netherlands, 3015 GD
        • University Medical Center Rotterdam Erasmus
      • Utrecht, Netherlands, 3584 CX
        • University Medical Centre Utrecht
      • Wageningen, Netherlands, 6703 HD
        • Wageningen Centre for Food Sciences
      • Zwolle, Netherlands, 8011 JW
        • Isala Klinieken (Locatie Wezenlanden)
  • Poland
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk
      • Katowice, Poland, 40-635
        • I Klinika Kardiologii
      • Szczecin, Poland, 70-111
        • Pomeranian Academy of Medicine
      • Warsaw, Poland, 02-637
        • Instytut Kardiologii
      • Warsaw, Poland, 04-073
        • Grochowski Hospital
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Voudois
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • London, United Kingdom, SW17 ORE
        • St George Hospital Medical School
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen Centre for Food Sciences

Collaborators

SEAFOODplus

Investigators

  • Study Chair: Evert G Schouten, MD, PhD, Wageningen Centre for Food Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion

January 1, 2005

Study Registration Dates

First Submitted

May 13, 2005

First Submitted That Met QC Criteria

May 13, 2005

First Posted (Estimate)

May 16, 2005

Study Record Updates

Last Update Posted (Estimate)

July 21, 2006

Last Update Submitted That Met QC Criteria

July 20, 2006

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TME/C-01.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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