Forteza Alberto, Evangelista Arturo, Sánchez Violeta, Teixidó Gisela, García Diana, Sanz Paz, Gutiérrez Laura, Centeno Jorge, Rodríguez-Palomares José, Cortina José, García-Dorado David
Unidad de Marfan, Hospital Universitario 12 de Octubre, Madrid, España.
Rev Esp Cardiol. 2011 Jun;64(6):492-8. doi: 10.1016/j.recesp.2011.02.009. Epub 2011 May 10.
Marfan syndrome is an inherited disease of the connective tissue. Recent trials have indicated the use of losartan (a transforming growth factor beta inhibitor) in these patients prevents aortic root enlargement. The aim of our clinical trial is to assess the efficacy and safety of losartan versus atenolol in the prevention of progressive dilation of the aorta in patients with Marfan syndrome.
This is a phase III clinical trial conducted in two institutions. A total of 150 subjects diagnosed with Marfan syndrome, aged between 5 and 60 years, of both sexes, and who meet the Ghent diagnostic criteria will be included in the study, with 75 patients per treatment group. It will be a randomized, double blind trial with parallel assignment to atenolol versus losartan (50 mg per day in patients below 50 kg and 100 mg per day in patients over 50 kg). Both growth and distensibility of the aorta will be assessed with echocardiography and magnetic resonance. Follow-up will be 3 years.
Efficacy of losartan versus atenolol in the prevention of progressive dilation of the aorta, improved aortic distensibility, and prevention of adverse events (aortic dissection or rupture, cardiovascular surgery, or death) will be assessed in this study. It will also show the possible treatment benefits at different age ranges and with relation to the initial level of aortic root dilation.
马方综合征是一种遗传性结缔组织疾病。近期试验表明，在这些患者中使用氯沙坦（一种转化生长因子β抑制剂）可预防主动脉根部扩张。我们临床试验的目的是评估氯沙坦与阿替洛尔在预防马方综合征患者主动脉进行性扩张方面的疗效和安全性。
这是一项在两个机构进行的III期临床试验。共有150名年龄在5至60岁之间、符合根特诊断标准的男女马方综合征患者将被纳入研究，每个治疗组75名患者。这将是一项随机、双盲试验，平行分配阿替洛尔与氯沙坦（体重低于50kg的患者每日50mg，体重超过50kg的患者每日100mg）。将通过超声心动图和磁共振评估主动脉的生长和扩张性。随访时间为3年。
本研究将评估氯沙坦与阿替洛尔在预防主动脉进行性扩张、改善主动脉扩张性以及预防不良事件（主动脉夹层或破裂、心血管手术或死亡）方面的疗效。它还将显示在不同年龄范围以及与主动脉根部扩张初始水平相关的可能治疗益处。
