Status:
COMPLETED
Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Agentschap voor Innovatie door Wetenschap en Technologie
Conditions:
Marfan Syndrome
Eligibility:
All Genders
10+ years
Phase:
PHASE3
Brief Summary
To study the effect of losartan (an angiotensin receptor blocker-ARB) on aortic root growth in patients with Marfan syndrome, already treated with beta-blockers (BB). The effect of losartan will be co...
Eligibility Criteria
Inclusion
- Patients \> 10 years
- Diagnosis of MFS, according to the Ghent criteria and/or genetically proven FBN1 mutations or linkage
- Consent obtained (written) either for the patient and for his/her parents (\<18y
- Z-score of the aorta at the level of the sinus of Valsalva ≥2 (BSA adjusted)
- ARB naïve patients
Exclusion
- Poor echocardiographic window,limiting the accurate measurement of the aortic root
- Contra-indication for ARB: Bilateral renal artery stenosis, renal function abnormalities (creatinine above normal for age), hyperkalemia
- Intolerance for ARB (eg angioedema)
- Pregnancy or breast feeding women
- Absence of effective contraception
- Liver function abnormalities
- Heart Failure
- Patients included in other clinical trial
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00782327
Start Date
November 1 2009
End Date
November 26 2014
Last Update
December 22 2022
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000