Revista Española de Cardiología (English Edition) Revista Española de Cardiología (English Edition)
Rev Esp Cardiol. 2011;64:492-8 - Vol. 64 Num.06 DOI: 10.1016/j.rec.2011.02.013

Study of the Efficacy and Safety of Losartan Versus Atenolol for Aortic Dilation in Patients With Marfan Syndrome

Alberto Forteza a,, Arturo Evangelista b, Violeta Sánchez a, Gisela Teixidó b, Diana García a, Paz Sanz a, Laura Gutiérrez b, Jorge Centeno a, José Rodríguez-Palomares b, José Cortina a, David García-Dorado b

a Unidad de Marfan, Hospital Universitario 12 de Octubre, Madrid, Spain
b Unidad de Marfan, Hospital Universitario Vall d’Hebron, Barcelona, Spain

Keywords

Marfan syndrome. Aorta. Losartan.

Abstract

Introduction and objectives

Marfan syndrome is an inherited disease of the connective tissue. Aortic rupture and dissection are the main causes of mortality in these patients. Recent trials have indicated the use of losartan (a transforming growth factor beta inhibitor) in these patients prevents aortic root enlargement. The aim of our clinical trial is to assess the efficacy and safety of losartan versus atenolol in the prevention of progressive dilation of the aorta in patients with Marfan syndrome.

Methods

This is a phase III clinical trial conducted in two institutions. A total of 150 subjects diagnosed with Marfan syndrome, aged between 5 and 60 years, of both sexes, and who meet the Ghent diagnostic criteria will be included in the study, with 75 patients per treatment group. It will be a randomized, double blind trial with parallel assignment to atenolol versus losartan (50mg per day in patients below 50kg and 100mg per day in patients over 50kg). Both growth and distensibility of the aorta will be assessed with echocardiography and magnetic resonance. Follow-up will be 3 years.

Conclusions

Efficacy of losartan versus atenolol in the prevention of progressive dilation of the aorta, improved aortic distensibility, and prevention of adverse events (aortic dissection or rupture, cardiovascular surgery, or death) will be assessed in this study. It will also show the possible treatment benefits at different age ranges and with relation to the initial level of aortic root dilation.

1885-5857/© 2011 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved

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