Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA)

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Placebo; Drug: Omega -3 fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT00970489

IND-104364

Details and patient eligibility

About

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).

Enrollment: 1,516 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,516 participants in 2 patient groups, including a placebo group

Omega-3 fatty acid capsules

Experimental group

Treatment:

Drug: Omega -3 fatty acids

Olive Oil capsule

Placebo Comparator group

Treatment:

Drug: Placebo