Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- normalised aortic diameter at the level of the sinus of valsalva
研究概览
简要总结
The purpose of this study is to evaluate if losartan limits aortic dilatation in patients with Marfan syndrome.
详细描述
Aim : evaluate the efficacy of losartan for limiting aortic dilatation in patients with marfan syndrome receiving standard therapy
Inclusion criteria :
10 years or older Marfan syndrome according to international criteria Signed informed consent
Non inclusion :
Previous surgery of the ascending aorta, or surgery planned Non echogenicity Contre-indication lactose Pregnancy on going or planned within 3 years Breast feeding Participation in another clinical study Non member of the social security or CMU
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 years or older
- •Marfan syndrome according to international criteria Signed informed consent
排除标准
- •Previous surgery of the ascending aorta, or surgery planned
- •Non echogenicity
- •Contre-indication lactose
- •Pregnancy on going or planned within 3 years
- •Breast feeding
- •Participation in another clinical study
- •Non member of the social security or CMU
研究组 & 干预措施
A: Placebo
placebo
干预措施: placebo (Drug)
B: Losartan
Losartan
干预措施: Losartan (Drug)
结局指标
主要结局
normalised aortic diameter at the level of the sinus of valsalva
时间窗: every six months
次要结局
- cardiac surgery, hospitalisation in cardiology ward, death(during the follow up)