NCT00970489

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,516

participants targeted

Target at P75+ for phase_3 atrial-fibrillation

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

August 31, 2009

Results QC Date

July 26, 2013

Last Update Submit

February 24, 2017

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationfish oil

Outcome Measures

Primary Outcomes (1)

  • Any First Post-op Atrial Fibrillation or Flutter (AF)

    Primary: Occurrence of post-CS AF (atrial fibrillation or flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG. This will include definite AF and probable AF (SVT likely to be AF depending on rate and other characteristics).

    up to 10 days post-surgery or discharge, whichever sooner

Secondary Outcomes (3)

  • Post-op Af

    up to 10 days post-surgery or discharge, whichever sooner

  • Other Arrhythmias

    up to 10 days post-surgery or discharge, whichever sooner

  • Other Endpoints

    up to 10 days post-surgery or discharge, whichever sooner

Study Arms (2)

Omega-3 fatty acid capsules

EXPERIMENTAL
Drug: Omega -3 fatty acids

Olive Oil capsule

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Omega -3 fatty acidsDRUG

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.

Omega-3 fatty acid capsules
PlaceboDRUG

Olive Oil capsules

Olive Oil capsule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US, Italy and Argentina

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

  • Akintoye E, Sethi P, Harris WS, Thompson PA, Marchioli R, Tavazzi L, Latini R, Pretorius M, Brown NJ, Libby P, Mozaffarian D. Fish Oil and Perioperative Bleeding. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004584. doi: 10.1161/CIRCOUTCOMES.118.004584.

    PMID: 30571332DERIVED

  • Jackson JC, Mozaffarian D, Graves AJ, Brown NJ, Marchioli R, Kiehl AL, Ely EW. Fish Oil Supplementation Does Not Affect Cognitive Outcomes in Cardiac Surgery Patients in the Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA) Trial. J Nutr. 2018 Mar 1;148(3):472-479. doi: 10.1093/jn/nxx002.

    PMID: 29546292DERIVED

  • Wu JH, Marchioli R, Silletta MG, Masson S, Sellke FW, Libby P, Milne GL, Brown NJ, Lombardi F, Damiano RJ Jr, Marsala J, Rinaldi M, Domenech A, Simon C, Tavazzi L, Mozaffarian D. Oxidative Stress Biomarkers and Incidence of Postoperative Atrial Fibrillation in the Omega-3 Fatty Acids for Prevention of Postoperative Atrial Fibrillation (OPERA) Trial. J Am Heart Assoc. 2015 May 20;4(5):e001886. doi: 10.1161/JAHA.115.001886.

    PMID: 25994442DERIVED

  • Wu JH, Marchioli R, Silletta MG, Macchia A, Song X, Siscovick DS, Harris WS, Masson S, Latini R, Albert C, Brown NJ, Lamarra M, Favaloro RR, Mozaffarian D. Plasma phospholipid omega-3 fatty acids and incidence of postoperative atrial fibrillation in the OPERA trial. J Am Heart Assoc. 2013 Oct 21;2(5):e000397. doi: 10.1161/JAHA.113.000397.

    PMID: 24145742DERIVED

  • Mozaffarian D, Marchioli R, Macchia A, Silletta MG, Ferrazzi P, Gardner TJ, Latini R, Libby P, Lombardi F, O'Gara PT, Page RL, Tavazzi L, Tognoni G; OPERA Investigators. Fish oil and postoperative atrial fibrillation: the Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) randomized trial. JAMA. 2012 Nov 21;308(19):2001-11. doi: 10.1001/jama.2012.28733.

    PMID: 23128104DERIVED

  • Mozaffarian D, Marchioli R, Gardner T, Ferrazzi P, O'Gara P, Latini R, Libby P, Lombardi F, Macchia A, Page R, Santini M, Tavazzi L, Tognoni G. The omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design. Am Heart J. 2011 Jul;162(1):56-63.e3. doi: 10.1016/j.ahj.2011.03.035. Epub 2011 Jun 12.

    PMID: 21742090DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Limitations and Caveats

Best-practice guidelines for preventing post-op atrial fibrillation were recommended to Centers. The duration prior to surgery may have been too short to be effective; or the dose of n-3 PUFA too low to produce benefit

Results Point of Contact

Title
Namasha Schelling
Organization
Harvard School of Public Health
nschelling@hsph.harvard.edu
617-432-1734

Study Officials

  • Dariush Mozaffarian, MD DrPH

    Harvard School of Public Health (HSPH)

    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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 2, 2009

Study Start

August 1, 2010

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

April 10, 2017

Results First Posted

April 10, 2017

Record last verified: 2017-02

Locations

US(1)