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Eficacia y Seguridad de Losartán vs Atenolol en la prevención de la dilatación progresiva de la aorta en la población de pacientes con Síndrome de Marfan (Losartan vs atenolol efficacy and security in aortic dilatation prevention in Marfan syndrome)

Eficacia y Seguridad de Losartán vs Atenolol en la prevención de la dilatación progresiva de la aorta en la población de pacientes con Síndrome de Marfan (Losartan vs atenolol efficacy and security in aortic dilatation prevention in Marfan syndrome)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001125-97-ES
Enrollment
Unknown
Registered
2007-12-03
Start date
2008-05-20
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

The aortic dilatation in Marfan syndrome with two different treatments: losartan vs atenolol MedDRA version: 9.1 Level: LLT Classification code 10026829 Term: Marfan's syndrome

Interventions

Trade Name: cozaar 50 Pharmaceutical Form: Capsule* INN or Proposed INN: LOSARTAN POTASSIUM CAS Number: 124750998 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50

Sponsors

alberto forteza
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Marfan syndrome patients between 7 and 60 years old. 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: a) Pregnancy or lactancy; b) Patients enrolled in other clinical trial; c) Previous cardiac or aortic surgery; d) Previous aortic disection ; e) Moderate or severe valvulopathy; f). Status NYHA III- IV; g) Respiratory, hepatic (ALT>3xLNS) or renal(creat < 30 ml/min) failure, or any other illness which modify the evaluation of the treatment.h) High hipersensibility, intolerance or contraindication to the treatment.

Design outcomes

Primary

MeasureTime frame
Main Objective: evaluate the role of losartan vs atenolol in the prevention of aortic dilatation in patients with marfan syndrome;Secondary Objective: Variations in elastic properties of the aortic wall. Incidence of clinical aspects: aortic disection, aortic rupture, aortic operation or death. Validation of the dose and efficacy of losartan. Modificacion of dural ectasia;Primary end point(s): Main variable assessed is the progression of aortic dilatation and one of the secondary variables is elasticity changes in the aorta wall in patients treated by losartan vs atenolol during 3 years of follow-up. Aorta dilatation was choosen as the main variable since it is related to dissection and aortic rupture.—

Countries

Spain

Outcome results

None listed

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