Clinical trial NCT00970489: Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
fish oil
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: The OPERA Investigators
First posted: 2009-09-02
Enrollment: 1516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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

Primary outcomes:
measure: Any First Post-op Atrial Fibrillation or Flutter (AF)
timeFrame: up to 10 days post-surgery or discharge, whichever sooner
Secondary outcomes:
measure: Post-op Af
timeFrame: up to 10 days post-surgery or discharge, whichever sooner
measure: Other Arrhythmias
timeFrame: up to 10 days post-surgery or discharge, whichever sooner
measure: Other Endpoints
timeFrame: up to 10 days post-surgery or discharge, whichever sooner
Other outcomes:
Locations:
city: Boston
country: United States
facility: US, Italy and Argentina
state: Massachusetts
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Dariush Mozaffarian, MD DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Roberto Marchioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.