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 · 152 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- National Institute of General Medical Sciences
- Gobierno
- NHLBI NIH HHS
- Gobierno
- NIGMS NIH HHS
- Subvenciones
- National Heart, Lung, and Blood Institute (R01 HL 091157); National Institute of General Medical Sciences (P20GM103652); National Heart, Lung, and Blood Institute (K23 HL127099)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2016-08-01 · Circulation · vol. 134 · número 5 · págs. 378–391
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 171 citas · más que el 100% de estudios similares · 20.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 38 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Fatty Acid Research and Health · Cardiovascular Function and Risk Factors · Cardiac Fibrosis and Remodeling
- Palabras clave
- 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 autores
- Bobak Heydari🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Shuaib M. Abdullah🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- James V. Pottala🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Ravi V. Shah🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Siddique A. Abbasi🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Damien Mandry🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Sanjeev A Francis🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Heidi S. Lumish🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Brian Burns Ghoshhajra🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Udo Hoffmann🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Evan A. Appelbaum🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Jiazhuo H. Feng🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Ron Blankstein🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Michael L. Steigner🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Joseph P. McConnell🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- William Stephen Harris🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Elliott Marshall Antman🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Michael Jerosch‐Herold🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
- Raymond Y.K. Kwong🇺🇸Brigham and Women's Hospital; Beth Israel Deaconess Medical Center; University of South Dakota; Massachusetts General Hospital; Medical Diagnostic Laboratories (United States)
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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