Back to results

Multi_center Study to Evaluate the Effect of N-3 Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation (AFFORD)

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

OMEGA-3

Placebo soybean oil

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

Montreal Heart Institute Coordinating Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

OMEGA-3

Placebo

Arm Description

Long-Chain N-3 polyunsaturated fatty acids (OMEGA-3)

Placebo soybean oil

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

High Sensitivity C-Reactive protein level

Based upon the primary endpoint, to demonstrate a relative reduction in CRP levels between the 2 groups

Cardiovascular-related death or Hospitalisation

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

Based upon the primary endpoint, to demonstrate a relative reduction in MPO levels between the 2 groups

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.

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.

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.

Dietary habits

Dietary habits will be evaluated using a standardized food frequency questionnaire (FFQ).

Full Information

NCT ID

NCT01235130

First Posted

July 29, 2010

Last Updated

March 1, 2022

Sponsor

Montreal Heart Institute

1. Study Identification

Unique Protocol Identification Number

NCT01235130

Brief Title

Multi_center Study to Evaluate the Effect of N-3 Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation

Acronym

AFFORD

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montreal Heart Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

337 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OMEGA-3

Arm Type

Active Comparator

Arm Description

Long-Chain N-3 polyunsaturated fatty acids (OMEGA-3)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo soybean oil

Intervention Type

Drug

Intervention Name(s)

OMEGA-3

Other Intervention Name(s)

Long-chain N-3 polyunsaturated fatty acids

Intervention Description

600mg, 2 caps, twice a day

Intervention Type

Drug

Intervention Name(s)

Placebo soybean oil

Intervention Description

600mg, 2caps twice a day

Primary Outcome Measure Information:

Title

Time to first relapse of atrial fibrillation

Description

Time Frame

After a three weeks loading phase

Secondary Outcome Measure Information:

Title

High Sensitivity C-Reactive protein level

Description

Based upon the primary endpoint, to demonstrate a relative reduction in CRP levels between the 2 groups

Time Frame

Measured at 0 and 6 months

Title

Cardiovascular-related death or Hospitalisation

Description

Time Frame

At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks)

Title

Serum myeloperoxidase level

Description

Based upon the primary endpoint, to demonstrate a relative reduction in MPO levels between the 2 groups

Time Frame

Measured at 0 and 6 months

Title

Major bleeding

Description

Time Frame

At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks)

Title

Quality of life data

Description

Time Frame

Measured at 0 week, 27 weeks, 47 weeks, and 67 weeks

Title

Resource utilization

Description

Time Frame

At each scheduled visit (3 weeks, 4 weeks, 7 weeks, 15 weeks, 27 weeks, 47 weeks and 67 weeks)

Title

Dietary habits

Description

Dietary habits will be evaluated using a standardized food frequency questionnaire (FFQ).

Time Frame

Measured at 0 week, 27 weeks, 47 weeks, and 67 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 .

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Anil Nigam, MD

Organizational Affiliation

Montreal Heart Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montreal Heart Institute Coordinating Center

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1Y 3N1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25277614

Citation

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.

Results Reference

derived

Learn more about this trial

Multi_center Study to Evaluate the Effect of N-3 Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation

We'll reach out to this number within 24 hrs