Status:
COMPLETED
SOFA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia
Lead Sponsor:
Wageningen Centre for Food Sciences
Collaborating Sponsors:
SEAFOODplus
Conditions:
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 arrh...
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 be...
Eligibility Criteria
Inclusion
- ICD is capable of recording ECG strips for at least 10 of its (attempted) therapeutic interventions
- 18 years or older
- written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT00110838
Start Date
October 1 2001
End Date
January 1 2005
Last Update
July 21 2006
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Wilhelminenspital
Vienna, Austria, A-1160
2
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
3
Interni Kardiologicka Klinika
Brno, Czechia, 63900
4
Institute of Clinical and Experimental Medicine
Prague, Czechia, 14021