Effect of Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction: The OMEGA-REMODEL Randomized Clinical Trial
Heydari B, Abdullah S, Pottala JV, Shah R, Abbasi S, Mandry D, Francis SA, Lumish H, Ghoshhajra BB, Hoffmann U, Appelbaum E, Feng JH, Blankstein R, Steigner M, McConnell JP, Harris W, Antman EM, Jerosch-Herold M, Kwong RY
Circulation · 149 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Government
- National Heart, Lung, and Blood Institute
- Government
- National Institute of General Medical Sciences
- Government
- NHLBI NIH HHS
- Government
- NIGMS NIH HHS
- Grants
- National Heart, Lung, and Blood Institute (R01 HL 091157); National Institute of General Medical Sciences (P20GM103652); National Heart, Lung, and Blood Institute (K23 HL127099)
Based on 4 listed funder(s).
Publication
- Published
- 2016-08-01 · Circulation · vol. 134 · issue 5 · pp. 378–391
- Publisher
- Lippincott Williams & Wilkins
- Cited
- 171 citations · more than 100% of similar papers · 20.2× the field average
- Impact
- Top 10% most cited in its field
- References
- 38 works
- Access
- Free to read
- Research areas
- Fatty Acid Research and Health · Cardiovascular Function and Risk Factors · Cardiac Fibrosis and Remodeling
- Keywords
- Medicine, Myocardial infarction, Cardiology, Internal medicine, Ejection fraction, Placebo, Omega 3 fatty acid, Clinical endpoint, Quartile, Ventricular remodeling, Fibrosis, Fatty acid, Heart failure, Randomized controlled trial, Polyunsaturated fatty acid, Pathology, Docosahexaenoic acid, Confidence interval
- MeSH
- heart ventricles, humans, myocardial infarction, fibrosis, inflammation, nausea, fatty acids, omega-3, troponin t, magnetic resonance imaging, organ size, treatment outcome, prospective studies, double-blind method, systole, ventricular remodeling, aged, middle aged, female, male, biomarkers
19 authors
From US
- Bobak HeydariBrigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Shuaib M. AbdullahBrigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- James V. PottalaBrigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Ravi V. ShahBrigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Siddique A. AbbasiBrigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Damien MandryBrigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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