N-3 fatty acid supplementation on arrhythmia recurrence in atrial fibrillation
| ISRCTN | ISRCTN52203885 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52203885 |
| Secondary identifying numbers | MCT-88068 |
- Submission date
- 30/06/2008
- Registration date
- 30/06/2008
- Last edited
- 25/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anil Nigam
Scientific
Scientific
Institut de Cardiologie de Montréal
5000 rue Bélanger est
Montreal, Quebec
H1T 1C8
Canada
| Phone | +1 514 376 3330 ext. 4033 |
|---|---|
| anil.nigam@icm-mhi.org |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised trial of the effect of long-chain n-3 polyunsaturated fatty acids on arrhythmia recurrence in atrial fibrillation |
| Study acronym | AFFORD |
| Study objectives | 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(s) | Research Ethics Committee of the Montreal Heart Institute/Institut de cardiologie de Montréal approved on the 14th May 2008 (ref: 08-1037) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2008 |
| Completion date | 01/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 332 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 01/04/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
Institut de Cardiologie de Montréal
Montreal, Quebec
H1T 1C8
Canada
H1T 1C8
Canada
Sponsor information
Montreal Heart Institute (Institut de cardiologie de Montréal) (Canada)
Research organisation
Research organisation
5000 est, rue Bélanger
Montreal, Quebec
H1T 1C8
Canada
| Website | http://www.icm-mhi.org/en/index.html |
|---|---|
"ROR" |
https://ror.org/03vs03g62 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-88068)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
