SOFA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia
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| ClinicalTrials.gov Identifier: NCT00110838 |
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Recruitment Status :
Completed
First Posted : May 16, 2005
Last Update Posted : July 21, 2006
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Sponsor:
Wageningen Centre for Food Sciences
Collaborator:
SEAFOODplus
Information provided by:
Wageningen Centre for Food Sciences
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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 |
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.
| 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 |
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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 ClinicalTrials.gov identifier (NCT number): NCT00110838
Locations
Show 27 study locations
Sponsors and Collaborators
Wageningen Centre for Food Sciences
SEAFOODplus
Investigators
| Study Chair: | Evert G Schouten, MD, PhD | Wageningen Centre for Food Sciences |
Additional Information:
Publications of Results:
Other Publications:
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 |
Keywords provided by Wageningen Centre for Food Sciences:
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fish oil n-3 fatty acids n-3 PUFA omega-3 fatty acids |
arrhythmia ICD human Patients with an implantable cardioverter defibrillator |
Additional relevant MeSH terms:
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Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |