The AT1 receptor antagonist losartan for the prevention of excessive aortic root dilatation in children and adolescents with Marfan syndrom

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016139-36-AT

Enrollment

Registered

2009-10-06

Start date

2009-12-28

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Marfan-Syndrom

Interventions

Trade Name: LOSARTAN "Hexal" 50 mg - Filmtabletten Product Name: Losartan Pharmaceutical Form: Tablet INN or Proposed INN: LOSARTAN CAS Number: 114798264 Concentration unit: mg/kg milligram(s)/kilogra

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 14, 2026