Effects of Losartan versus Nebivolol versus the association of both on the progression of aortic root dilation in Marfan Syndrome (MFS) with FBN1 gene mutations - ND

Phase 1

Active, not recruiting

Conditions: Marfan Syndrome
MedDRA version: 9.1Level: LLTClassification code 10026829Term: Marfan's syndrome

Registration Number: EUCTR2008-001462-81-IT

Lead Sponsor: OSPEDALE POLICLINICO S. MATTEO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

patients aged 12 months to 55 years without prior aortic surgery with a BSA-adjusted aortic root z score >/= 2.5.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

prior aortic surgery and/or dissection, aortic root diameter at the level of the sinuses of valsalva >/= 5 cm, planned aortic surgery within 6 months of enrolment for a rate of ARD progression > 5 mm/year even in pts with ARD less than 5 cm, ...

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: the comparative evaluation of the effects of Losartan, Nebivolol and the association of both on the progression of aortic root growth rate (measured at the level of the sinuses of valsalva).;Secondary Objective: are: the pharmacokinetics of the two drugs by age and dosages: the comparative evaluation of the serum levels of total and active TGFb, the quantitative assessment of the expression of the mutated gene (FBN1, both 5' and 3'), the pharmacogenetic bases of drug responsiveness by testing the variants of the CYP2C9 gene for losartan and of the CYP2D6 gene for nebivolol.;Primary end point(s): the decrease of the rate of progression of aortic root dilation in 291 patients with MFS randomly assigned to losartan, nebivolol and the association of both, treated for 48 months.

Secondary Outcome Measures