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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001462-81-IT

Enrollment

Unknown

Registered

2008-03-17

Start date

2008-10-27

Completion date

Unknown

Last updated

2016-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marfan Syndrome MedDRA version: 9.1 Level: LLT Classification code 10026829 Term: Marfan's syndrome

Interventions

Trade Name: LORTAAN*28CPR RIV DIV 50MG Pharmaceutical Form: Coated tablet INN or Proposed INN: Losartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade N

Eligibility

Sex/Gender

All

Inclusion criteria

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

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, ...

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026