SOFA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia
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ClinicalTrials.gov Identifier: NCT00110838 |
Recruitment Status :
Completed
First Posted : May 16, 2005
Last Update Posted : July 21, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arrhythmia | Procedure: Supplementation with fish oil versus placebo | Phase 3 |
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 |
- Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
- 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

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00110838

Study Chair: | Evert G Schouten, MD, PhD | Wageningen Centre for Food Sciences |
Publications of Results:
Other Publications:
ClinicalTrials.gov 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 |
fish oil n-3 fatty acids n-3 PUFA omega-3 fatty acids |
arrhythmia ICD human Patients with an implantable cardioverter defibrillator |
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |