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

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

Detailed Description
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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.

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

Conditions
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Marfan Syndrome

Intervention / Treatment
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* Drug: placebo
* Drug: Losartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A: Placebo<br>placebo | Drug: placebo<br>* Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators). For example, interventions involving drugs may include dosage form, dosage, frequency and duration.<br>|
| Active Comparator: B: Losartan<br>Losartan | Drug: Losartan<br>* 50 mg/day if < weight 50 kg 100 mg/day if weight > 50 kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normalised aortic diameter at the level of the sinus of valsalva |  | every six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac surgery, hospitalisation in cardiology ward, death |  | during the follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Marfan syndrome, Angiotensin II Type 1 Receptor Blockers, Aortic Aneurysm, Thoracic