- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01235130
Multi_center Study to Evaluate the Effect of N-3 Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation (AFFORD)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H1Y 3N1
- Montreal Heart Institute Coordinating Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 years
- Written informed consent
- Non-valvular paroxysmal or persistent AF in whom a rhythm control strategy is planned
- Duration of at least one symptomatic AF episode > 10 minutes within the past 6 months
- ECG documentation of AF
Exclusion Criteria:
- Chronic AF (continuously present for > 3 months)
- Myocardial infarction within the past month prior to selection visit
- Cardiac or thoracic surgery within the past 3 months or likely to be performed during trial
- Moderate to severe congestive heart failure (NHYA FC III-IV)
- Known left ventricular dysfunction (EF< 40%).
- Mitral stenosis
- Moderate to severe mitral insufficiency (Grade 3-4/4)
- AF secondary to an acute reversible condition (untreated or uncontrolled hyperthyroidism, post- operative AF, fever, anemia)
- Need for anti-arrhythmic therapy for a condition other than atrial fibrillation
- Wolff-Parkinson-White syndrome
- Any medical condition making compliance with study treatment unlikely
- Current use of n-3 fatty acid supplements or use within the past 3 months
- Pregnancy, breastfeeding, or possibility of becoming pregnant during the study (Patients must have adequate contraception as determined by the investigator),
- Participation in another study at the same time or within 30 days of randomization.
- Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
- Suspected or known allergy to any ingredients in the study product or placebo, fish or shellfish .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: OMEGA-3
Long-Chain N-3 polyunsaturated fatty acids (OMEGA-3)
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600mg, 2 caps, twice a day
Other Names:
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PLACEBO_COMPARATOR: Placebo
Placebo soybean oil
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600mg, 2caps twice a day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first relapse of atrial fibrillation
Time Frame: After a three weeks loading phase
|
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.
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After a three weeks loading phase
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High Sensitivity C-Reactive protein level
Time Frame: Measured at 0 and 6 months
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Based upon the primary endpoint, to demonstrate a relative reduction in CRP levels between the 2 groups
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Measured at 0 and 6 months
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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)
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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.
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At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks)
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Serum myeloperoxidase level
Time Frame: Measured at 0 and 6 months
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Based upon the primary endpoint, to demonstrate a relative reduction in MPO levels between the 2 groups
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Measured at 0 and 6 months
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Major bleeding
Time Frame: At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks)
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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.
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At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks)
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Quality of life data
Time Frame: Measured at 0 week, 27 weeks, 47 weeks, and 67 weeks
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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.
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Measured at 0 week, 27 weeks, 47 weeks, and 67 weeks
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Resource utilization
Time Frame: At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks)
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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.
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At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks)
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Dietary habits
Time Frame: Measured at 0 week, 27 weeks, 47 weeks, and 67 weeks
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Dietary habits will be evaluated using a standardized food frequency questionnaire (FFQ).
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Measured at 0 week, 27 weeks, 47 weeks, and 67 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr. Anil Nigam, MD, Montreal Heart Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCT88068 (OTHER_GRANT: CIHR MCT88068)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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