Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
The purpose of this study is to evaluate if losartan limits aortic dilatation in patients
 with Marfan syndrome.
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.
Inclusion Criteria:

 -  10 years or older

 -  Marfan syndrome according to international criteria Signed informed consent

 Exclusion Criteria:

 -  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