A Phase 3 interventional study of placebo and Losartan in Marfan Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2015-11-04.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
71 studies on the registry are indexed under Marfan Syndrome; 16 are open to participants now.
This study's enrollment of 303 is above the median of 40 across 31 interventional studies indexed under Marfan Syndrome.
Browse Marfan Syndrome studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
placebo
Drug: placebo
Losartan
Drug: Losartan
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.
50 mg/day if \< weight 50 kg 100 mg/day if weight \> 50 kg
normalised aortic diameter at the level of the sinus of valsalva
Time frame: every six months
cardiac surgery, hospitalisation in cardiology ward, death
Time frame: during the follow up
This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris