-
Randomized Controlled Trial Comparative Study
[Study of the efficacy and safety of losartan versus atenolol for aortic dilation in patients with Marfan syndrome].
- Alberto Forteza, Arturo Evangelista, Violeta Sánchez, Gisela Teixidó, Diana García, Paz Sanz, Laura Gutiérrez, Jorge Centeno, José Rodríguez-Palomares, José Cortina, and David García-Dorado.
- Unidad de Marfan, Hospital Universitario 12 de Octubre, Madrid, España.
- Rev Esp Cardiol. 2011 Jun 1;64(6):492-8.
Introduction And ObjectivesMarfan syndrome is an inherited disease of the connective tissue. 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.MethodsThis 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 (50 mg per day in patients below 50 kg and 100 mg per day in patients over 50 kg). Both growth and distensibility of the aorta will be assessed with echocardiography and magnetic resonance. Follow-up will be 3 years.ConclusionsEfficacy 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.Copyright © 2011 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.
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