Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
Study Overview
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 investigators will examine the effect of high dose of Menaquinone-7 (MK-7) supplementation (1000 mcg)/day on the progression of the aortic valve disease. The investigators hypothesize that MK-7 supplementation may slow or even reverse the progression of the disease process.
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 using:
- 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3
- 5000 IU/d Vitamin D3 as a control group
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •AVCS > 300 without aortic valve stenosis requiring operation
- •Focus on patients with:
- •Bicuspid aortic valve
- •Dialysis or CKD
- •Statin treatment
Exclusion Criteria
- •Use of Vitamin K antagonist
- •Malabsorption Problem
- •LVEF < 40%
- •A life expectancy < 3 years
Arms & Interventions
Interventional
1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve
Intervention: Vitamin K2 (Menaquinone 7) + Vitamin D3 (Dietary Supplement)
interventional
5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study
Intervention: Vitamin K2 (Menaquinone 7) + Vitamin D3 (Dietary Supplement)
Outcomes
Primary Outcomes
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
Time Frame: 3 years
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)
Time Frame: 3 years
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)
Time Frame: 3 years
Secondary Outcomes
- Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.(3 years)
- Improvement of the quality of life of the patients(3 years)
- Improvement of dyspnea (at rest and effort)(3 years)
- Reduction of the Aortic Valve calcification measured by CT Scan(3 years)
Investigators
Rodolph Frangi
Head of Department of Thoracic and Cardiovascular surgery
Hopital St. Georges, Ajaltoun