NCT01235130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P50-P75 for phase_3 atrial-fibrillation

Timeline
Completed

Started Mar 2009

Typical duration for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

3.8 years

First QC Date

July 29, 2010

Last Update Submit

March 1, 2022

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • High Sensitivity C-Reactive protein level

    Measured at 0 and 6 months

  • Cardiovascular-related death or Hospitalisation

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

  • Serum myeloperoxidase level

    Measured at 0 and 6 months

  • Major bleeding

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

  • Quality of life data

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

  • +2 more secondary outcomes

Study Arms (2)

OMEGA-3

ACTIVE COMPARATOR

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

Drug: OMEGA-3

Placebo

PLACEBO COMPARATOR

Placebo soybean oil

Drug: Placebo soybean oil

Interventions

OMEGA-3DRUG

600mg, 2 caps, twice a day

Also known as: Long-chain N-3 polyunsaturated fatty acids
OMEGA-3
Placebo soybean oilDRUG

600mg, 2caps twice a day

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute Coordinating Center

Montreal, Quebec, H1Y 3N1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25277614DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Dr. Anil Nigam, MD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2010

First Posted

November 5, 2010

Study Start

March 1, 2009

Primary Completion

December 1, 2012

Study Completion

May 1, 2013

Last Updated

March 17, 2022

Record last verified: 2022-03

Locations

CA(1)