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

Assistance Publique - Hôpitaux de Paris

Status and phase: Terminated; Phase 3

Conditions: Marfan Syndrome

Treatments: Drug: placebo; Drug: Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT00763893

P060210

2006-006112-30 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 303 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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303 participants in 2 patient groups, including a placebo group

A: Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo

B: Losartan

Active Comparator group

Description:

Losartan

Treatment:

Drug: Losartan