跳至主要内容
临床试验/NCT00651235
NCT00651235Unknown2 期

A Randomized, Open-label, Active Control Trial to Evaluate the Effect of LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
44
试验地点
1
主要终点
Echocardiograms

研究概览

简要总结

To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome.

详细描述

Marfan syndrome (MFS) is a multisystem connective tissue disorder of autosomal dominant inheritance1. The cardinal features are noted in the cardiovascular, ocular, and skeletal system. The most life-threatening complication of MFS is progressive aortic root dilation leading to aortic dissection or rupture. Losartan, an angiotensin II type I receptor (AT1) antagonist, is a drug already in clinical use for hypertension and type II diabetic nephropathy. A recent study showed that Losartan prevents aortic root dilation and lung problem in a mouse model of MFS. Therefore, the goals of this clinical trial are to examine the efficacy and safety of Losartan in patients with Marfan syndrome for aortic root dilation prevention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

B

Experimental

In combination therapy,the maximal dose of Losartan is 100 mg/day for adult and 50 mg/day for children. 50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children

干预措施: Losartan and Atenolol or Propranolol (Drug)

A

Active Comparator

The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.

干预措施: Atenolol or Propranolol (Drug)

结局指标

主要结局

Echocardiograms

时间窗: 4 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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