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

Phase 3

Terminated

• Conditions: Marfan Syndrome
• Interventions: Drug: placebo; Drug: Losartan

• Registration Number: NCT00763893
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Primary Completion: 2014-01
• Study Completion: 2014-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 303

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Placebo	placebo	placebo
B: Losartan	Losartan	Losartan

Primary Outcome Measures

Name	Time	Method
normalised aortic diameter at the level of the sinus of valsalva	every six months

Secondary Outcome Measures

Name	Time	Method
cardiac surgery, hospitalisation in cardiology ward, death	during the follow up

Trial Locations

Locations (1)

Hôpital Bichat; 🇫🇷 Paris, France