Effect of Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction: The OMEGA-REMODEL Randomized Clinical Trial

Circulation. 2016 Aug 2;134(5):378-91. doi: 10.1161/CIRCULATIONAHA.115.019949.

Abstract

Background: Omega-3 fatty acids from fish oil have been associated with beneficial cardiovascular effects, but their role in modifying cardiac structures and tissue characteristics in patients who have had an acute myocardial infarction while receiving current guideline-based therapy remains unknown.

Methods: In a multicenter, double-blind, placebo-controlled trial, participants presenting with an acute myocardial infarction were randomly assigned 1:1 to 6 months of high-dose omega-3 fatty acids (n=180) or placebo (n=178). Cardiac magnetic resonance imaging was used to assess cardiac structure and tissue characteristics at baseline and after study therapy. The primary study endpoint was change in left ventricular systolic volume index. Secondary endpoints included change in noninfarct myocardial fibrosis, left ventricular ejection fraction, and infarct size.

Results: By intention-to-treat analysis, patients randomly assigned to omega-3 fatty acids experienced a significant reduction of left ventricular systolic volume index (-5.8%, P=0.017), and noninfarct myocardial fibrosis (-5.6%, P=0.026) in comparison with placebo. Per-protocol analysis revealed that those patients who achieved the highest quartile increase in red blood cell omega-3 index experienced a 13% reduction in left ventricular systolic volume index in comparison with the lowest quartile. In addition, patients in the omega-3 fatty acid arm underwent significant reductions in serum biomarkers of systemic and vascular inflammation and myocardial fibrosis. There were no adverse events associated with high-dose omega-3 fatty acid therapy.

Conclusions: Treatment of patients with acute myocardial infarction with high-dose omega-3 fatty acids was associated with reduction of adverse left ventricular remodeling, noninfarct myocardial fibrosis, and serum biomarkers of systemic inflammation beyond current guideline-based standard of care.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00729430.

Keywords: endomyocardial fibrosis; fatty acids, omega-3; infarction; magnetic resonance imaging; ventricular remodeling.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Biomarkers
  • Double-Blind Method
  • Fatty Acids, Omega-3 / adverse effects
  • Fatty Acids, Omega-3 / pharmacology
  • Fatty Acids, Omega-3 / therapeutic use*
  • Female
  • Fibrosis
  • Heart Ventricles
  • Humans
  • Inflammation / blood
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Myocardial Infarction / complications*
  • Nausea / virology
  • Organ Size
  • Prospective Studies
  • Systole
  • Treatment Outcome
  • Troponin T / blood
  • Ventricular Remodeling / drug effects*

Substances

  • Biomarkers
  • Fatty Acids, Omega-3
  • Troponin T

Associated data

  • ClinicalTrials.gov/NCT00729430