Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome. - Archive ouverte HAL Access content directly
Journal Articles Archives of cardiovascular diseases Year : 2010

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

(1) , (2) , (3) , (3) , (4, 5) , (6) , (7) , (8) , (9) , (10) , (1) , (1) , (1, 11) , (1) , (1, 12) , (1, 13)
1
2
3
4
5
6
7
8
9
10
11
12
13
Mathieu Gautier

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.

Dates and versions

inserm-00511671 , version 1 (25-08-2010)

Identifiers

Cite

Delphine Detaint, Philippe Aegerter, Florence Tubach, Isabelle Hoffman, Henri Plauchu, et al.. Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome.. Archives of cardiovascular diseases, 2010, 103 (5), pp.317-25. ⟨10.1016/j.acvd.2010.04.008⟩. ⟨inserm-00511671⟩
204 View
0 Download

Altmetric

Share

Gmail Facebook Twitter LinkedIn More