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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
140
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 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
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
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.
Time frame: Until February 2013
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