SOFA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia
Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
1 other identifier
interventional
546
8 countries
27
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2001
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 13, 2005
CompletedFirst Posted
Study publicly available on registry
May 16, 2005
CompletedJuly 21, 2006
May 1, 2005
May 13, 2005
July 20, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- ICD is capable of recording ECG strips for at least 10 of its (attempted) therapeutic interventions
- years or older
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Centre for Food Scienceslead
- SEAFOODpluscollaborator
Study Sites (27)
Wilhelminenspital
Vienna, A-1160, Austria
Universitair Ziekenhuis Gent
Ghent, B-9000, Belgium
Interni Kardiologicka Klinika
Brno, 63900, Czechia
Institute of Clinical and Experimental Medicine
Prague, 14021, Czechia
Kerckhoff-Klinik GmbH
Bad Nauheim, D-61231, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, D-32545, Germany
Klinikum Benjamin Franklin Berlin
Berlin, 12200, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Klinikum der Friedrich-Schiller-Universitat
Jena, D-07747, Germany
Stiftsklinik Augustinum
Munich, 81375, Germany
Universitatsklinikum Muenster
Münster, 48149, Germany
Academic Medical Centre Amsterdam
Amsterdam, 1105 AZ, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
St. Antoniusziekenhuis
Nieuwegein, 3435 CM, Netherlands
University Medical Center Rotterdam Erasmus
Rotterdam, 3015 GD, Netherlands
University Medical Centre Utrecht
Utrecht, 3584 CX, Netherlands
Wageningen Centre for Food Sciences
Wageningen, 6703 HD, Netherlands
Isala Klinieken (Locatie Wezenlanden)
Zwolle, 8011 JW, Netherlands
Medical University of Gdansk
Gdansk, 80-211, Poland
I Klinika Kardiologii
Katowice, 40-635, Poland
Pomeranian Academy of Medicine
Szczecin, 70-111, Poland
Instytut Kardiologii
Warsaw, 02-637, Poland
Grochowski Hospital
Warsaw, 04-073, Poland
Centre Hospitalier Universitaire Voudois
Lausanne, 1011, Switzerland
Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
St George Hospital Medical School
London, SW17 ORE, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (2)
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.
PMID: 14506496BACKGROUNDBrouwer 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.
PMID: 16772624RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Evert G Schouten, MD, PhD
Wageningen Centre for Food Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 13, 2005
First Posted
May 16, 2005
Study Start
October 1, 2001
Study Completion
January 1, 2005
Last Updated
July 21, 2006
Record last verified: 2005-05