Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Marfan Syndrome
Intervention: placebo (Drug); Losartan (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Guillaume JONDEAU, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
Guillaume JONDEAU, MD,PhD, Phone: 01 40 25 68 11, Email: guillaume.jondeau@bch.aphp.fr
Summary
The purpose of this study is to evaluate if losartan limits aortic dilatation in patients
with Marfan syndrome.
Clinical Details
Official title: Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: normalised aortic diameter at the level of the sinus of valsalva
Secondary outcome: cardiac surgery, hospitalisation in cardiology ward, death
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.
Eligibility
Minimum age: 10 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Guillaume JONDEAU, MD,PhD, Phone: 01 40 25 68 11, Email: guillaume.jondeau@bch.aphp.fr
Hôpital Bichat, Paris 75018, France; Recruiting
Guillaume JONDEAU, MD, PhD, Phone: 01 40 25 68 11, Email: guillaume.jondeau@bch.aphp.fr
Guillaume JONDEAU, MD,PhD, Principal Investigator
Additional Information
Starting date: September 2008
Ending date: September 2013
Last updated: April 1, 2009
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