Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome (MARFANSARTAN)
The purpose of this study is to evaluate if losartan limits aortic dilatation in patients with Marfan syndrome.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome|
- normalised aortic diameter at the level of the sinus of valsalva [ Time Frame: every six months ] [ Designated as safety issue: Yes ]
- cardiac surgery, hospitalisation in cardiology ward, death [ Time Frame: during the follow up ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||August 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: A: 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.
Other Name: placebo
Active Comparator: B: Losartan
50 mg/day if < weight 50 kg 100 mg/day if weight > 50 kg
Other Name: Losartan
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763893
|Paris, France, 75018|
|Principal Investigator:||Guillaume JONDEAU, MD, PhD||Assistance Publique - Hôpitaux de Paris|