EUCTR2010-019302-16-GB进行中（未招募）1 期
A prospective, randomised, placebo-controlled, double blind, multi-centre study of the effects of Irbesartan on aortic dilatation in Marfan syndrome - The AIMS Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 490
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Clinically confirmed MFS using the Ghent diagnostic criteria
- •2. 2.Aorta dilated above the 95% normal confidence limits (using accepted methods)
- •3. Provision of informed consent
- •4. From 6 = to = 40 years of age inclusive
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous cardiac or aortic surgery
- •2. Planned cardiac or aortic surgery at the time of randomisation
- •3. Aortic diameter >=4.5cm
- •4. Haemodynamically significant, severe valvular disease (at the judgement of the treating clinician)
- •5. Heart failure, defined as left ventricular ejection fraction < 40%
- •6. Therapeutic use of ACE inhibitors/angiotensin-II receptor antagonist
- •7. Previous recorded adverse reaction to the trial medication (Irbesartan) or any ACE inhibitor/angiotensin-II receptor antagonist
- •8. Female patients who are pregnant, planning pregnancy or not using reliable contraception
- •9. Impaired renal function defined as estimated creatinine clearance <60ml/minute, or serum creatinine >150micromol/litre
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