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

This study has been completed.
Sponsor:
Collaborator:
SEAFOODplus
Information provided by:
Wageningen Centre for Food Sciences
ClinicalTrials.gov Identifier:
NCT00110838
First received: May 13, 2005
Last updated: July 20, 2006
Last verified: May 2005
  Purpose

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 Intervention Phase
Arrhythmia
Procedure: Supplementation with fish oil versus placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study

Resource links provided by NLM:


Further study details as provided by Wageningen Centre for Food Sciences:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 546
Study Start Date: October 2001
Estimated Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110838

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

Publications:
ClinicalTrials.gov Identifier: NCT00110838     History of Changes
Other Study ID Numbers: TME/C-01.07
Study First Received: May 13, 2005
Last Updated: July 20, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Wageningen Centre for Food Sciences:
fish oil
n-3 fatty acids
n-3 PUFA
omega-3 fatty acids
arrhythmia
ICD
human
Patients with an implantable cardioverter defibrillator

ClinicalTrials.gov processed this record on October 23, 2014