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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014