Status:
UNKNOWN
Nebivolol Versus Losartan Versus Nebivolol+Losartan Against Aortic Root Dilation in Genotyped Marfan Patients
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Menarini Group
Conditions:
Marfan Syndrome
Eligibility:
All Genders
12-55 years
Phase:
PHASE3
Brief Summary
The major clinical problems in patients with Marfan Syndrome (MFS) are aortic root dilation (ARD), dissection and rupture. Although the available treatments (beta-blockers, BBs) improve the evolution ...
Detailed Description
Marfan Syndrome is a rare disease (1:5000)(MIM#154700) caused by mutations of the Fibrillin 1 (FBN1) gene. The major clinical problem is aortic aneurysm with risk of dissection when root diameter is 5...
Eligibility Criteria
Inclusion
- Diagnosis of MFS: Ghent criteria and genetically proven defect of the FBN1 gene
- Age: 12 months to 55 years
- BSA-adjusted aortic z score = or \>2 measured at the level of the sinuses of Valsalva at baseline according to Roman's method, or absolute aortic root diameter \>38mm for females and \>40 mm for males
Exclusion
- Prior aortic surgery and/or dissection
- Aortic root diameter at the level of the sinuses of Valsalva 5 cm
- Planned aortic surgery within 6 months of enrollment for a rate of ARD progression\>5 mm/year even in pts with ARD less than 5 cm
- Clinical or molecular diagnosis of non-MFS connective tissue diseases sharing some features with MFS (Shprintzen-Goldberg syndrome or Loeys-Dietz syndromes)
- Un-renounceable therapeutic (systemic hypertension, arrhythmia, ventricular dysfunction, valve regurgitation) use of drugs such as ACE inhibitors, BBs, or calcium-channel blockers
- Known side-effects while taking an ARB or a BB
- Intolerance to ARB that resulted in termination of therapy
- Intolerance to BB that resulted in termination of therapy
- Renal dysfunction (creatinine level more than upper limit of age-related normal values)
- Diabetes mellitus
- Pregnancy or planned pregnancy within 48 months of enrollment
- Technical limitations for the imaging studies including poor acoustic windows with limits the accurate measurement of aortic root
- Asthma.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00683124
Start Date
July 1 2008
End Date
July 1 2013
Last Update
July 22 2011
Active Locations (1)
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1
IRCCS Foundation San Matteo Hospital
Pavia, Italy, 27100