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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anil Nigam, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01235130
First received: July 29, 2010
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: OMEGA-3
Drug: Placebo soybean oil
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 337
Study Start Date: March 2009
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OMEGA-3
Long-Chain N-3 polyunsaturated fatty acids (OMEGA-3)
Drug: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. Written informed consent
  3. Non-valvular paroxysmal or persistent AF in whom a rhythm control strategy is planned
  4. Duration of at least one symptomatic AF episode > 10 minutes within the past 6 months
  5. ECG documentation of AF

Exclusion Criteria:

  1. Chronic AF (continuously present for > 3 months)
  2. Myocardial infarction within the past month prior to selection visit
  3. Cardiac or thoracic surgery within the past 3 months or likely to be performed during trial
  4. Moderate to severe congestive heart failure (NHYA FC III-IV)
  5. Known left ventricular dysfunction (EF< 40%).
  6. Mitral stenosis
  7. Moderate to severe mitral insufficiency (Grade 3-4/4)
  8. AF secondary to an acute reversible condition (untreated or uncontrolled hyperthyroidism, post- operative AF, fever, anemia)
  9. Need for anti-arrhythmic therapy for a condition other than atrial fibrillation
  10. Wolff-Parkinson-White syndrome
  11. Any medical condition making compliance with study treatment unlikely
  12. Current use of n-3 fatty acid supplements or use within the past 3 months
  13. Pregnancy, breastfeeding, or possibility of becoming pregnant during the study (Patients must have adequate contraception as determined by the investigator),
  14. Participation in another study at the same time or within 30 days of randomization.
  15. Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
  16. Suspected or known allergy to any ingredients in the study product or placebo, fish or shellfish .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235130

Locations
Canada, Quebec
Montreal Heart Institute Coordinating Center
Montreal, Quebec, Canada, H1Y 3N1
Sponsors and Collaborators
Montreal Heart Institute
Investigators
Principal Investigator: Dr. Anil Nigam, MD Montreal Heart Institute
  More Information

No publications provided

Responsible Party: Anil Nigam, Principal Investigator, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01235130     History of Changes
Other Study ID Numbers: MCT88068, MCT88068
Study First Received: July 29, 2010
Last Updated: May 21, 2013
Health Authority: Canada: Health Canada
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Cardiovascular Diseases
Disease Attributes
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014