Multi_center Study to Evaluate the Effect of N-3 Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation (AFFORD)
The general objective of this study is to demonstrate the effectiveness of n-3 fatty acids, 2.4 grams per day, to prevent recurrence of atrial fibrillation in patients with paroxysmal or persistent AF in whom a rhythm-control strategy is planned.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 3 A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Long-chain N-3 Polyunsaturated Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation|
- Time to first relapse of atrial fibrillation [ Time Frame: After a three weeks loading phase ] [ Designated as safety issue: No ]The primary endpoint will be the time to first relapse of AF during the follow-up period. Relapse is defined as any ECG-documented episode of AF lasting longer than 30 seconds, symptomatic or asymptomatic. ECG-documented AF refers to episodes documented either by trans-telephonic event recorder, 12-lead ECG or Holter monitor.
- High Sensitivity C-Reactive protein level [ Time Frame: Measured at 0 and 6 months ] [ Designated as safety issue: No ]Based upon the primary endpoint, to demonstrate a relative reduction in CRP levels between the 2 groups
- Cardiovascular-related death or Hospitalisation [ Time Frame: At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks) ] [ Designated as safety issue: Yes ]Data on CV-related hospitalization will be collected prospectively during scheduled patient visits with patients being asked about any emergency room visits, hospital admissions or bleeding since their last scheduled visit.
- Serum myeloperoxidase level [ Time Frame: Measured at 0 and 6 months ] [ Designated as safety issue: No ]Based upon the primary endpoint, to demonstrate a relative reduction in MPO levels between the 2 groups
- Major bleeding [ Time Frame: At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks) ] [ Designated as safety issue: No ]Data on bleeding episodes will be collected prospectively during scheduled patient visits with patients being asked about any emergency room visits, hospital admissions or bleeding since their last scheduled visit.
- Quality of life data [ Time Frame: Measured at 0 week, 27 weeks, 47 weeks, and 67 weeks ] [ Designated as safety issue: No ]Quality of life will be evaluated using questionnaires: Toronto Atrial Fibrillation Severity Scale (AFSS), Severity of Atrial Fibrillation Scale (SAF), SF-12, EuroQol-5, Anxiety Severity Scale and Beck Depression Inventory-II.
- Resource utilization [ Time Frame: At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks) ] [ Designated as safety issue: No ]Resource utilisation including drugs, cardioversions attempts, hospitalization days, emergency department visits, outpatient physician visits and pacemaker and catheter-based procedures will be recorded and converted to costs according to the methods described by the National List of provincial Cost Heath Care: Canada 1997/8.
- Dietary habits [ Time Frame: Measured at 0 week, 27 weeks, 47 weeks, and 67 weeks ] [ Designated as safety issue: No ]Dietary habits will be evaluated using a standardized food frequency questionnaire (FFQ).
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Active Comparator: OMEGA-3
Long-Chain N-3 polyunsaturated fatty acids (OMEGA-3)
600mg, 2 caps, twice a day
Other Name: Long-chain N-3 polyunsaturated fatty acids
|Placebo Comparator: Placebo||
Drug: Placebo soybean oil
600mg, 2caps twice a day
Other Name: Placebo soybean oil
Atrial fibrillation (AF) represents the most common arrhythmia of clinical importance. The prevalence of AF in the general population has been estimated to be just below 1%, or 300,000 Canadians, and rising. Current strategies in AF to preserve normal sinus rhythm include pharmacological therapy with agents that demonstrate intermediate efficacy and significant adverse effects. Newer non-pharmacological strategies such as pulmonary vein ablation are suitable for only a minority of patients and are an expensive method of treatment. As a result, simple, safe, inexpensive and effective strategies to treat AF and preserve sinus rhythm are required given the great health and financial burden that this condition represents to our society.
Omega-3 or "n-3" polyunsaturated fatty acids (n-3 fatty acids) represent a novel approach to the prevention and treatment of AF. N-3 fatty acids have known anti-arrhythmic properties and are associated with a lower risk of sudden (arrhythmic) death. Additionally, n-3 fatty acids have significant anti-inflammatory properties and potential anti-oxidant effects. Higher consumption of non-fried fish was recently shown to confer a lower incidence of new onset AF in elderly adults. N-3 fatty acids might therefore represent a useful strategy for maintenance of sinus rhythm in patients with AF, given their potential to act on several mechanisms simultaneously. We seek to test this hypothesis in the current clinical trial proposal.
|Contact: Katy Rivard, PhD||(514)461-1300 ext firstname.lastname@example.org|
|Contact: Dr. Anil Nigam, MD||(514)376-3330 ext email@example.com|
|Montreal Heart Institute Coordinating Center||Recruiting|
|Montreal, Quebec, Canada, H1Y 3N1|
|Contact: Manon Provencher, BSc (514)461-1300 ext 2038 firstname.lastname@example.org|
|Contact: Dr. Anil Nigam, MD (514)376-3330 ext 4033 email@example.com|
|Principal Investigator: Dr. Anil Nigam, MD|
|Principal Investigator:||Dr. Anil Nigam, MD||Montreal Heart Institute|