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Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome — MARFANSARTAN  

Marfan Syndrome Clinical Trial

Official title:
Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome

Clinical Trial Summary

The purpose of this study is to evaluate if losartan limits aortic dilatation in patients with Marfan syndrome.

Clinical Trial Description

Aim : evaluate the efficacy of losartan for limiting aortic dilatation in patients with marfan syndrome receiving standard therapy

Inclusion criteria :

10 years or older Marfan syndrome according to international criteria Signed informed consent

Non inclusion :

Previous surgery of the ascending aorta, or surgery planned Non echogenicity Contre-indication lactose Pregnancy on going or planned within 3 years Breast feeding Participation in another clinical study Non member of the social security or CMU

Number of subjects : the number of subjects (150 per group) is derived from the study from Shores et al (1994) demonstrating the benefit of beta-blockade in Marfan patient and uses a decrease by half of the aortic dilatation with losartan

Follow-up is 3 years, after inclusion period of 2 years. A total of 5 years is expected

Methods : randomised double blind vs placebo study. All French centres de competence for marfan syndrome and the centre de reference are participating in the study.

End points : main endpoint is evolution of normalised aortic diameter. Secondary endpoints include clinical events (cardiac surgery or aortic dissection, hospitalisation in cardiology department, death), tolerance of the drug, and quality of life. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00763893
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Terminated
Phase Phase 3
Start date September 2008
Completion date December 2014
View Details
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