(OPERA)Randomized Clinical Trial to Examine Whether Peri-operative Intake of n-3 Polyunsaturated Fatty Acids Will Reduce the Occurrence of Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 1,516
- Locations
- 1
- Primary Endpoint
- Any First Post-op Atrial Fibrillation or Flutter (AF)
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Omega-3 fatty acid capsules
Intervention: Omega -3 fatty acids (Drug)
Olive Oil capsule
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Any First Post-op Atrial Fibrillation or Flutter (AF)
Time Frame: up to 10 days post-surgery or discharge, whichever sooner
Primary: Occurrence of post-CS AF (atrial fibrillation or flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG. This will include definite AF and probable AF (SVT likely to be AF depending on rate and other characteristics).
Secondary Outcomes
- Other Arrhythmias(up to 10 days post-surgery or discharge, whichever sooner)
- Post-op Af(up to 10 days post-surgery or discharge, whichever sooner)
- Other Endpoints(up to 10 days post-surgery or discharge, whichever sooner)
Investigators
Dariush Mozaffarian, MD
Associate Professor of Medicine
Brigham and Women's Hospital