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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega-3 fatty acid capsules

Group Type EXPERIMENTAL

Omega -3 fatty acids

Intervention Type DRUG

10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.

Olive Oil capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Olive Oil capsules

Interventions

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Omega -3 fatty acids

10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.

Intervention Type DRUG

Placebo

Olive Oil capsules

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dariush Mozaffarian, MD

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dariush Mozaffarian, MD DrPH

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Roberto Marchioli, MD

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Clinical Epidemiology of Cardiovascular Disease Department of Clinical Pharmacology and Epidemiology Consorzio Mario Negri Sud Via Nazionale 8/A S. Maria Imbaro (Chieti), 66030 ITALY