Phase 3
N=1,516
Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00970489 ↗Enrolled (actual)
1,516
Serious AEs
18.7%
Results posted
Apr 2017
Primary outcome: Primary: Any First Post-op Atrial Fibrillation or Flutter (AF) — 233; 227 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omega -3 fatty acids (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Any First Post-op Atrial Fibrillation or Flutter (AF) |
233; 227 | — |
| SECONDARY Post-op Af |
231; 224; 220; 217 | — |
| SECONDARY Other Arrhythmias |
6; 11; 9; 5 | — |
| SECONDARY Other Endpoints |
20; 13; 15; 8 | — |
Summary
This is a large multi-center study to examine whether peri-operative intake of n-3 polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS).
Eligibility Criteria
Inclusion Criteria
- Age 18 years or over
- Scheduled for CS on the following day or later, including coronary artery bypass, valve surgery, any other open cardiac surgery (i.e., that includes opening of the pericardium), or any combination.
- Sinus rhythm on current ECG (sinus bradycardia, sinus tachycardia, and ectopy are acceptable).
Exclusion Criteria
- Regular use (3 or more days/week) of fish oil within the past 4 weeks.
- Known allergy or intolerance to fish oil or corn oil.
- Currently pregnant.
- Unable to provide informed written consent.
- Current or planned cardiac transplant or LVAD
Data sourced from ClinicalTrials.gov (NCT00970489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.