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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-12-31

Brief Summary

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

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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.

Conditions

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Marfan Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A: Placebo

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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.

B: Losartan

Losartan

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

50 mg/day if \< weight 50 kg 100 mg/day if weight \> 50 kg

Interventions

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placebo

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.

Intervention Type DRUG

Losartan

50 mg/day if \< weight 50 kg 100 mg/day if weight \> 50 kg

Intervention Type DRUG

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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No