osartan and Marfan syndrome
Recruiting
- Conditions
- Marfan syndrome - Marfan syndroomlosartan aneurysmaaorta
- Registration Number
- NL-OMON25140
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 330
Inclusion Criteria
1. Marfan syndrome diagnosed according to Ghent criteria
Exclusion Criteria
1. More than one vascular prosthesis for the primary end-point evaluation.
2. Aortic root dimension > 5 cm.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method argest change in absolute aortic diameter evaluated at all aortic levels in one patient: <br />losartan group versus not-treated control group measured with MRA or Multi-slice CT.
- Secondary Outcome Measures
Name Time Method • Change in mortality, incidence of newly diagnosed dissection in any main vessel and incidence of elective aortic surgery combined with the primary endpoint.<br /><br>• Change of aortic volume measured by MRA.<br /><br>• Change of aortic wall stiffness measured by MRA.<br /><br>• Change of left ventricular size and ejection fraction measured with MRI.<br /> <br>• Prediction model for aortic growth.<br /><br>• Prediction model for treatment response to losartan therapy based on multiple biochemical, immunohystological and expression biomarkers.<br /><br>• Change in the quality of life scores.