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Sponsors and Collaborators: |
Wageningen Centre for Food Sciences IP SEAFOODplus |
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Information provided by: | Wageningen Centre for Food Sciences |
ClinicalTrials.gov Identifier: | NCT00110838 |
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 |
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Arrhythmia |
Procedure: Supplementation with fish oil versus placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study |
Estimated Enrollment: | 546 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | January 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Wilhelminenspital | |
Vienna, Austria, A-1160 | |
Belgium | |
Universitair Ziekenhuis Gent | |
Gent, Belgium, B-9000 | |
Czech Republic | |
Institute of Clinical and Experimental Medicine | |
Prague, Czech Republic, 14021 | |
Interni Kardiologicka Klinika | |
Brno, Czech Republic, 63900 | |
Germany | |
Herz- und Diabeteszentrum Nordrhein-Westfalen | |
Bad Oeynhausen, Germany, D-32545 | |
Stiftsklinik Augustinum | |
Munich, Germany, 81375 | |
Universitatsklinikum Muenster | |
Muenster, Germany, 48149 | |
Klinikum Benjamin Franklin Berlin | |
Berlin, Germany, 12200 | |
Kerckhoff-Klinik GmbH | |
Bad Nauheim, Germany, D-61231 | |
Charité - Universitätsmedizin Berlin | |
Berlin, Germany, 13353 | |
Klinikum der Friedrich-Schiller-Universitat | |
Jena, Germany, D-07747 | |
Netherlands | |
Wageningen Centre for Food Sciences | |
Wageningen, Netherlands, 6703 HD | |
Isala Klinieken (Locatie Wezenlanden) | |
Zwolle, Netherlands, 8011 JW | |
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 | |
Academic Medical Centre Amsterdam | |
Amsterdam, Netherlands, 1105 AZ | |
Poland | |
Grochowski Hospital | |
Warsaw, Poland, 04-073 | |
Instytut Kardiologii | |
Warsaw, Poland, 02-637 | |
Medical University of Gdansk | |
Gdansk, Poland, 80-211 | |
Pomeranian Academy of Medicine | |
Szczecin, Poland, 70-111 | |
I Klinika Kardiologii | |
Katowice, Poland, 40-635 | |
Switzerland | |
Centre Hospitalier Universitaire Voudois | |
Lausanne, Switzerland, 1011 | |
United Kingdom | |
Queen Elizabeth Hospital | |
Birmingham, United Kingdom, B15 2TH | |
Southampton General Hospital | |
Southampton, United Kingdom, SO16 6YD | |
St George Hospital Medical School | |
London, United Kingdom, SW17 ORE |
Study Chair: | Evert G Schouten, MD, PhD | Wageningen Centre for Food Sciences |
Study ID Numbers: | TME/C-01.07 |
Study First Received: | May 13, 2005 |
Last Updated: | July 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00110838 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Germany: Federal Institute for Drugs and Medical Devices |
fish oil n-3 fatty acids n-3 PUFA omega-3 fatty acids |
arrhythmia ICD human Patients with an implantable cardioverter defibrillator |
Heart Diseases Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |