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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110838
Recruitment Status : Completed
First Posted : May 16, 2005
Last Update Posted : July 21, 2006
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Arrhythmia Procedure: Supplementation with fish oil versus placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
Study Start Date : October 2001
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Primary Outcome Measures :
  1. Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality

Secondary Outcome Measures :
  1. All cause mortality (separately from ventricular tachyarrhythmia)
  2. Cardiac mortality
  3. Myocardial infarction
  4. All arrhythmic events as documented by the ICD Core laboratory
  5. Change in the prescription of antiarrhythmic drugs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110838

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Sponsors and Collaborators
Wageningen Centre for Food Sciences
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Study Chair: Evert G Schouten, MD, PhD Wageningen Centre for Food Sciences
Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00110838    
Other Study ID Numbers: TME/C-01.07
First Posted: May 16, 2005    Key Record Dates
Last Update Posted: July 21, 2006
Last Verified: May 2005
Keywords provided by Wageningen Centre for Food Sciences:
fish oil
n-3 fatty acids
n-3 PUFA
omega-3 fatty acids
Patients with an implantable cardioverter defibrillator
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes