A prospective, randomised, placebo-controlled, double blind, multi-centre study of the effects of Irbesartan on aortic dilatation in Marfan syndrome
- Conditions
- Marfan Syndrome
- Registration Number
- EUCTR2010-019302-16-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 490
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method