The AT1 receptor antagonist losartan for the prevention of excessive aortic root dilatation in children and adolescents with Marfan syndrom
- Conditions
- Marfan-Syndrom
- Registration Number
- EUCTR2009-016139-36-AT
- Lead Sponsor
- Medizinische Universität Wien, Univ.Klinik für Kinder-und Jugendheilkunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-Marfan diagnosis according to Ghent criteria
-Genetic proof of a Fibrillin 1 mutation
-age between 1 and 25 years
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Syndroms similar to Marfan Syndrom ( Loeys Dietz syndrom, Shprintzen Goldberg syndrom)
- Intolerance approximately ARB
- Renal dysfunktion
- Aortic root diameter>50mm,waiting for the operation
- preceeding Aortic root replacement-therapy
- preventive therapy with ß-blokers, calciumcanalblocker,s ace-inhibitors must be terminated
- pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The efficacy of the medication Losartan on the increase of the aorticroot diameter and vascular wallstiffness;Secondary Objective: hyperhomcysteinaemia;Primary end point(s): The efficacy of the medication Losartan on the increase of the aorticroot diameter and vascular wallstiffness
- Secondary Outcome Measures
Name Time Method