Status:
UNKNOWN
Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
Lead Sponsor:
Hopital St. Georges, Ajaltoun
Collaborating Sponsors:
Omicron Pharmaceuticals
Nattopharma ASA
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
30-85 years
Phase:
PHASE2
Brief Summary
Aortic Stenosis is a common but fatal disease when it becomes symptomatic, specially if not treated. Until now surgery remains the only reliable and effective treatment. In this study, the investigat...
Detailed Description
The study is a randomized clinical trial that will use Cardiac Echography and multi-detector computed tomography to compare the changes in the Aortic Valve Calcification Score (AVCS) over 3 years when...
Eligibility Criteria
Inclusion
- AVCS \> 300 without aortic valve stenosis requiring operation
- Focus on patients with:
- Bicuspid aortic valve
- Dialysis or CKD
- Statin treatment
Exclusion
- Use of Vitamin K antagonist
- Malabsorption Problem
- LVEF \< 40%
- A life expectancy \< 3 years
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03305536
Start Date
January 2 2018
End Date
December 1 2020
Last Update
August 9 2019
Active Locations (1)
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1
Hopital Saint-George Ajaltoun
Beirut, Lebanon