Condition category
Circulatory System
Date applied
30/06/2008
Date assigned
30/06/2008
Last edited
25/03/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anil Nigam

ORCID ID

Contact details

Institut de Cardiologie de Montréal
5000 rue Bélanger est
Montreal
Quebec
H1T 1C8
Canada
+1 514 376 3330 ext. 4033
anil.nigam@icm-mhi.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-88068

Study information

Scientific title

Randomised trial of the effect of long-chain n-3 polyunsaturated fatty acids on arrhythmia recurrence in atrial fibrillation

Acronym

AFFORD

Study hypothesis

Primary hypothesis:
1. N-3 fatty acid supplementation reduces the recurrence of atrial fibrillation (AF) relative to placebo

Secondary hypotheses:
2. N-3 fatty acid supplementation reduces markers of inflammation high sensitivity C-reactive protein [hs-CRP]) relative to placebo
3. N-3 fatty acid supplementation reduces markers of oxidative stress (serum myeloperoxidase) relative to placebo

Ethics approval

Research Ethics Committee of the Montreal Heart Institute/Institut de cardiologie de Montréal approved on the 14th May 2008 (ref: 08-1037)

Study design

Double blind (investigator, participant, caregiver, data analyst, outcome assessor) randomised parallel assignment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular disease/cardiac arrhythmias

Intervention

Experimental:
N-3 polyunsaturated fatty acids (fish oil) given daily as 2.4 g eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) daily over a minimum treatment period of 6 months (two capsules twice daily).

Control:
Matching placebo containing safflower oil given daily as two placebo capsules twice daily over a minimum treatment period of 6 months.

Intervention type

Supplement

Phase

Not Applicable

Drug names

N-3 fatty acid supplementation

Primary outcome measures

Time to first relapse of atrial fibrillation measured from 0 to 6 months minimum, up to 16 months if no AF recurrence between 6 - 16 months.

Secondary outcome measures

1. High-sensitivity C-reactive protein levels measured at 0 and 6 months
2. Serum myeloperoxidase levels measured at 0 and 6 months

Overall trial start date

01/09/2008

Overall trial end date

01/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than or equal to 18 years, either sex
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 greater than 10 minutes within the past 6 months
5. Electrocardiogram (ECG) documentation of AF
6. Left ventricular (LV) ejection fraction greater than 40%
7. Normal thyroid stimulating hormone (TSH)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

332

Participant exclusion criteria

1. Chronic AF (continuously present for greater than 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 (New York Heart Association Functional Class [NHYA FC] III - IV)
5. Left ventricular dysfunction (ejection fraction [EF] less than 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, anaemia)
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

Recruitment start date

01/09/2008

Recruitment end date

01/04/2010

Locations

Countries of recruitment

Canada

Trial participating centre

Institut de Cardiologie de Montréal
Montreal, Quebec
H1T 1C8
Canada

Sponsor information

Organisation

Montreal Heart Institute (Institut de cardiologie de Montréal) (Canada)

Sponsor details

5000 est
rue Bélanger
Montreal
Quebec
H1T 1C8
Canada

Sponsor type

Research organisation

Website

http://www.icm-mhi.org/en/index.html

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-88068)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes