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Publikasi Scopus 926 artikel (Per 14 Maret 2022)
Publikasi Scopus 926 artikel (Per 14 Maret 2022)
Randomised controlled trial into the role of ramipril in fibrosis reduction in rheumatic heart disease: The RamiRHeD trial protocol
2021
BMJ Open
11
9
e048016
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85115217044&doi=10.1136%2fbmjopen-2020-048016&partnerID=40&md5=37438fc881ccc33516a8361ba43e3971
Department of Cardiovascular Prevention and Rehabilitation, National Cardiovascular Center Harapan Kita, West Jakarta Jakarta, Indonesia; Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia, West Jakarta Jakarta, Indonesia; Research Assistant of Department of Cardiovascular Prevention and Rehabilitation, National Cardiovascular Center Harapan Kita, West Jakarta Jakarta, Indonesia; Department of Cardiology, University Medical Centre Utrecht, Utrecht, Netherlands; Central Military Hospital, Netherlands Heart Institute, Utrecht, Netherlands
Introduction Rheumatic heart disease (RHD) is a major burden in developing countries and accounts for 80% of all people living with the disease, where it causes most cardiovascular morbidity and mortality in children and young adults. Chronic inflammation and fibrosis of heart valve tissue due to chronic inflammation in RHD will cause calcification and thickening of the impacted heart valves, especially the mitral valve. This fibrogenesis is enhanced by the production of angiotensin II by increased transforming growth factor β expression and later by the binding of interleukin-33, which is known to have antihypertrophic and antifibrotic effects, to soluble sST2. sST2 binding to this non-natural ligand worsens fibrosis. Therefore, we hypothesise that ACE inhibitors (ACEIs) would improve rheumatic mitral valve stenosis. Methods and analysis This is a single-centre, double-blind, placebo-controlled, randomised clinical trial with a pre-post test design. Patients with rheumatic mitral stenosis and valve dysfunction will be planned for cardiac valve replacement operation and will be given ramipril 5 mg or placebo for a minimum of 12 weeks before the surgery. The expression of ST2 in the mitral valve is considered to be representative of cardiac fibrosis. Mitral valve tissue will be stained by immunohistochemistry to ST2. Plasma ST2 will be measured by ELISA. This study is conducted in the Department of Cardiology and Vascular Medicine, Universitas Indonesia, National Cardiac Center Harapan Kita Hospital, Jakarta, Indonesia, starting on 27 June 2019. Ethics and dissemination The performance and dissemination of this study were approved by the ethics committee of National Cardiovascular Center Harapan Kita with ethical code LB.02.01/VII/286/KEP.009/2018. Trial registration number NCT03991910. © 2021 BMJ Publishing Group. All rights reserved.
interleukin 1 receptor like 1 protein; placebo; ramipril; ramipril; adult; Article; clinical trial protocol; controlled study; double blind procedure; enzyme linked immunosorbent assay; female; heart muscle fibrosis; human; human tissue; immunohistochemistry; Indonesia; male; mitral valve stenosis; pretest posttest design; protein blood level; protein expression; randomized controlled trial; rheumatic heart disease; child; fibrosis; heart surgery; mitral valve stenosis; randomized controlled trial (topic); young adult; Cardiac Surgical Procedures; Child; Fibrosis; Humans; Mitral Valve Stenosis; Ramipril; Randomized Controlled Trials as Topic; Rheumatic Heart Disease; Young Adult
BMJ Publishing Group
20446055
34518254
Article
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1132
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