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| ID | Type | Description | Link |
|---|---|---|---|
| MCT88068 | Other Grant/Funding Number | CIHR MCT88068 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMEGA-3 | Active Comparator | Long-Chain N-3 polyunsaturated fatty acids (OMEGA-3) |
|
| Placebo | Placebo Comparator | Placebo soybean oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMEGA-3 | Drug | 600mg, 2 caps, twice a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first relapse of atrial fibrillation | 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. | After a three weeks loading phase |
| Measure | Description | Time Frame |
|---|---|---|
| High Sensitivity C-Reactive protein level | Based upon the primary endpoint, to demonstrate a relative reduction in CRP levels between the 2 groups | Measured at 0 and 6 months |
| Cardiovascular-related death or Hospitalisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Anil Nigam, MD | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute Coordinating Center | Montreal | Quebec | H1Y 3N1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25277614 | Derived | Nigam A, Talajic M, Roy D, Nattel S, Lambert J, Nozza A, Jones P, Ramprasath VR, O'Hara G, Kopecky S, Brophy JM, Tardif JC; AFFORD Investigators. Fish oil for the reduction of atrial fibrillation recurrence, inflammation, and oxidative stress. J Am Coll Cardiol. 2014 Oct 7;64(14):1441-8. doi: 10.1016/j.jacc.2014.07.956. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Placebo soybean oil | Drug | 600mg, 2caps twice a day |
|
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.
| At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks) |
| Serum myeloperoxidase level | Based upon the primary endpoint, to demonstrate a relative reduction in MPO levels between the 2 groups | Measured at 0 and 6 months |
| Major bleeding | 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. | At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks) |
| Quality of life data | 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. | Measured at 0 week, 27 weeks, 47 weeks, and 67 weeks |
| Resource utilization | 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. | At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks) |
| Dietary habits | Dietary habits will be evaluated using a standardized food frequency questionnaire (FFQ). | Measured at 0 week, 27 weeks, 47 weeks, and 67 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |