NCT01145612

Atenolol Versus Losartan in the Prevention of Progressive Dilation of the Aorta in Marfan Syndrome

A Clinical Trial to Assess the Efficacy and Safety of Losartan Versus Atenolol in the Prevention of Progressive Dilation of the Aorta in Patients With Marfan Syndrome.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Forteza, Albert, M.D. · Individual
• Sex: All
• Age: 5 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Marfan Syndrome

Interventions

Type	Name	Description
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
DRUG	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

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-06-16
• Last updated: 2010-08-12

Locations

2 sites across 1 country: Spain