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

This study has been completed.
Sponsor:
Collaborator:
The OPERA Investigators
Information provided by (Responsible Party):
Dariush Mozaffarian, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00970489
First received: August 31, 2009
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
 Drug: Omega -3 fatty acids
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Atrial Fibrillation [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of sustained or symptomatic atrial fibrillation [ Time Frame: up to 10 days post-surgery or discharge, whichever sooner ] [ Designated as safety issue: No ]

Enrollment: 1516
Study Start Date: August 2010
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega-3 fatty acid capsules Drug: 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.
Placebo Comparator: Olive Oil capsule Drug: Placebo
Olive Oil capsules

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970489

Locations
United States, Massachusetts
US, Italy and Argentina
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
The OPERA Investigators
Investigators
Principal Investigator: Dariush Mozaffarian, MD DrPH Harvard School of Public Health
Principal Investigator: Roberto Marchioli, MD 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
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dariush Mozaffarian, MD, Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00970489     History of Changes
Other Study ID Numbers: IND-104364
Study First Received: August 31, 2009
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
atrial fibrillation
fish oil

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013