Publication
Title
The Ghent Marfan Trial - A randomized, double-blind placebo controlled trial with losartan in Marfan patients treated with beta-blockers
Author
Abstract
Background: Aortic root dilation, dissection and rupture are major clinical problems in Marfan syndrome (MFS). Although beta-blockers remain the standard of preventive treatment, preliminary results from animal studies and a selected group of severely affected MFS children show significant benefit from treatment with losartan, an angiotensin II receptor blocker with TGF-beta inhibiting potential. Large-scale human trials are now needed to confirm these results. This trial aims to evaluate the combined effect of both drugs. Methods: We are conducting a prospective randomized placebo controlled double blind phase III study aiming to include 174 MFS patients (age >= 10 years and z-score >= 2). Patients already taking beta-blockers are randomized for weight-adjusted treatment with losartan versus placebo. The primary endpoint is decrease in aortic root growth rate. Secondary endpoints are aortic dissection/surgery, progression of aortic/mitral regurgitation, arterial stiffness, left ventricular systolic/diastolic function, quality of life and genetic modifiers. Echocardiography, vascular echo-Doppler and quality of life assessment will be performed at baseline and at 6-monthly follow-ups for 3 years. MRI evaluation will be performed at baseline and at the end of the trial. Conclusion: This trial will study new therapeutic strategies for the prevention of serious cardiovascular complications in MFS. The uniqueness in our trial is that the additive effect of losartan and beta-blocker will be evaluated in a large spectrum of disease severity. A combination of ultrasound and MRI will allow detailed evaluation of anatomic and functional properties of the aorta and left ventricle. (C) 2010 Elsevier Ireland Ltd. All rights reserved.
Language
English
Source (journal)
International journal of cardiology. - Amsterdam, 1981, currens
Publication
Amsterdam : 2012
ISSN
0167-5273
Volume/pages
157 :3 (2012) , p. 354-358
ISI
000304245900015
Full text (Publisher's DOI)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
External links
Web of Science
Record
Identification
Creation 05.11.2018
Last edited 05.10.2021