EFFECTS OF LOSARTAN ON AORTIC ROOT AND ASCENDING AORTA REMODELING IN PATIENTS WITH BICUSPID AORTIC VALVE. - CARDPED-2010-01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018880-41-IT

Enrollment

Registered

2010-05-21

Start date

2010-06-01

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

PATIENTS WITH BICUSPID AORTIC VALVE. MedDRA version: 12.1 Level: LLT Classification code 10004552 Term: Bicuspid aortic valve

Interventions

Trade Name: LORTAAN Pharmaceutical Form: Tablet INN or Proposed INN: Losartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Normofunctioning bicuspid aortic valve : dp max inferior to 25 mmHg and aortic regurgitation absent, or trivial, or mild, or mild-moderate; 2. Increased aortic root and/or ascending aorta diameters and/or reduced aortic compliance 3. Age superior or egual to 10 years and inferior to 65 years 4. Written consent form signed 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: dp max superior to 25 mmHg ; aortic regurgitation more than mild-moderate; Normal aortic root and ascending aorta diameters and normal aortic compliance Pregnancy Brest feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effects of losartan on compliance and aortic root and ascending aorta diameters in patients with bicuspid aortic valve.;Secondary Objective: To evaluate the safety of losartan treatment in patients with BICUSPID AORTIC VALVE.;Primary end point(s): Evaluation of aortic root and ascending aorta dilatation and prevalence of reduced aortic compliance in patients with bicuspid aortic valve, Aortic diameters and distensibility and stiffness index in patients without theraphy at baseline and after 1 year, Aortic diameters and distensibility and stiffness index in patients treated with losartan at baseline and after 1 year.	—

Measure

Time frame

Main Objective: To evaluate the effects of losartan on compliance and aortic root and ascending aorta diameters in patients with bicuspid aortic valve.;Secondary Objective: To evaluate the safety of losartan treatment in patients with BICUSPID AORTIC VALVE.;Primary end point(s): Evaluation of aortic root and ascending aorta dilatation and prevalence of reduced aortic compliance in patients with bicuspid aortic valve, Aortic diameters and distensibility and stiffness index in patients without theraphy at baseline and after 1 year, Aortic diameters and distensibility and stiffness index in patients treated with losartan at baseline and after 1 year.

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Countries

Italy

Outcome results

None listed

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