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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01145612
Other study ID # LO-AT-MARFAN-01
Secondary ID 2007-001125-97
Status Active, not recruiting
Phase Phase 3
First received June 15, 2010
Last updated August 11, 2010
Start date October 2008
Est. completion date February 2013

Study information

Verified date June 2010
Source Forteza, Albert, M.D.
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of HealthSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilatation in patients with Marfan syndrome.


Description:

Marfan syndrome is a genetic disease of the connective tissue. Patients with Marfan syndrome experience an expansion of the aorta that can lead to dissection or rupture of it. This is the main cause of mortality in these patients.

The main objective of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.

The measurement is made by echocardiography, assessing the diameter of the aorta in different zones: valve annulus, sinuses of Valsalva, sinotubular junction, ascending aorta, aortic arch, thoracic and abdominal aorta.

A total number of 150 subjects diagnosed with Marfan syndrome and who meet the diagnostic criteria of Ghent, of both sexes, 75 per treatment group, aged between 5 and 60, will be included in the study. The study is being conducted in two Spanish hospitals.

The treatment is maintained throughout the study period.


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Losartan
Losartán dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg
Atenolol
Atenolol dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg

Locations

Country Name City State
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital 12 de Octubre Madrid

Sponsors (2)

Lead Sponsor Collaborator
Forteza, Albert, M.D. Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression of aortic dilation in patients with Marfan syndrome. Evaluate the eficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome. Until February 2013 No
See also
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Completed NCT01715207 - Comparison Study of the Effect of Aliskiren Versus Negative Controls on Aortic Stiffness in Patients With Marfan Syndrome Under Treatment With Atenolol Phase 3
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Recruiting NCT04776681 - Living With Marfans and Your Aorta: Surgical Outcomes Study
Completed NCT03236571 - Cardiorespiratory and Muscular Rehabilitation of Children and Young Adults With Marfan Syndrome. N/A
Recruiting NCT00683124 - Nebivolol Versus Losartan Versus Nebivolol+Losartan Against Aortic Root Dilation in Genotyped Marfan Patients Phase 3