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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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