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; Guillaume Jondeau

doi:10.1016/j.acvd.2010.04.008

Journal articles

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 ¹ Philippe Aegerter ² Florence Tubach ³ Isabelle Hoffman ³ Henri Plauchu ^{4, 5} Yves Dulac ⁶ Laurence Olivier Faivre ⁷ Marie-Ange Delrue ⁸ Patrick Collignon ⁹ Sylvie Odent ¹⁰ Maria Tchitchinadze ¹ Catherine Bouffard ¹ Florence Arnoult ^{1, 11} Mathieu Gautier ¹ Catherine Boileau ^{1, 12} Guillaume Jondeau ^{1, 13, *}

* Corresponding author

1 Service de cardiologie

2 VIMA - Vieillissement et Maladies chroniques : approches épidémiologique et de santé publique

3 CIC epidémiologie clinique/ essais cliniques, Hôpital Bichat - Claude Bernard

4 Service de Génétique

5 UCBL - Université Claude Bernard Lyon 1

6 Service pédiatrie-cardiologie

7 Centre de génétique - Centre de référence des maladies rares, anomalies du développement et syndromes malformatifs (CHU de Dijon)

8 Service de génétique médicale

9 Département de génétique médicale [Hôpital de la Timone - APHM]

10 Service de génétique clinique

11 Service d'explorations fonctionnelles

12 Service de biochimie, d'hormonologie et de génétique moléculaire [CHU Amrboise Paré]

13 LBPC - Hémostase, bio-ingénierie et remodelage cardiovasculaires

Abstract : BACKGROUND: Recent 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). AIMS: To demonstrate a beneficial effect of losartan on aortic dilatation when added to optimal therapy in patients with Marfan syndrome. METHODS: This 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. CONCLUSION: The 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.

Document type :

Journal articles

Domain :

Life Sciences [q-bio] / Human health and pathology / Cardiology and cardiovascular system

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https://www.hal.inserm.fr/inserm-00511671
Contributor : Hervé de Villemeur <>
Submitted on : Wednesday, August 25, 2010 - 4:12:34 PM
Last modification on : Friday, January 15, 2021 - 3:10:03 AM

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

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

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