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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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.

Brief 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 Summary:

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.


Sponsor: Forteza, Albert, M.D.

Current Primary Outcome: Progression of aortic dilation in patients with Marfan syndrome. [ Time Frame: Until February 2013 ]

Evaluate the eficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Forteza, Albert, M.D.

Dates:
Date Received: June 15, 2010
Date Started: October 2008
Date Completion: February 2013
Last Updated: August 11, 2010
Last Verified: June 2010