• Arch Cardiovasc Dis · May 2010

    Randomized Controlled Trial Multicenter Study

    Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome.

    • Delphine Detaint, Philippe Aegerter, Florence Tubach, Isabelle Hoffman, Henri Plauchu, Yves Dulac, Laurence Olivier Faivre, Marie-Ange Delrue, Patrick Collignon, Sylvie Odent, Maria Tchitchinadze, Catherine Bouffard, Florence Arnoult, Mathieu Gautier, Catherine Boileau, and Guillaume Jondeau.
    • Centre de référence pour le syndrome de Marfan et apparentés, hôpital Bichat, Paris, France.
    • Arch Cardiovasc Dis. 2010 May 1;103(5):317-25.

    BackgroundRecent studies have demonstrated that blockade of the angiotensin II type 1 receptor with losartan decreases aortic damage in an animal model of Marfan syndrome (a KI mouse model with a pathogenic mutation in the gene coding for fibrillin-1).AimsTo demonstrate a beneficial effect of losartan on aortic dilatation when added to optimal therapy in patients with Marfan syndrome.MethodsThis is a multicentre, randomized, placebo-controlled, double-blind, clinical trial with a 2-year inclusion period and a 3-year follow-up period. Aortic root diameter will be measured using two-dimensional echocardiography. Secondary endpoints will include incidence of aortic dissection, aortic root surgery, death, quality of life, tolerance and compliance with treatments. We aim to enroll a total of 300 patients aged > or =10 years who fulfil the Ghent criteria for Marfan syndrome. Analyses will be based on intention to treat.ConclusionThe results of this clinical trial could lead to profound modification of the management of aortic risk and complications in patients with Marfan syndrome and possibly in patients with thoracic aortic aneurysms of other aetiologies.2010 Elsevier Masson SAS. All rights reserved.

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