Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)

Study Overview
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Brief Summary
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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
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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

Official Title
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Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventional<br>1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve | Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3<br>* Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease<br>* Other names: K2/D3;|
| Active Comparator: interventional<br>5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study | Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3<br>* Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease<br>* Other names: K2/D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg) |  | 3 years | 
| Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2) |  | 3 years | 
| Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification. | Lowering of dephosphorelated-undercarboxylated matrix Gla protein (dp-ucMGP picomol/l) Reduction of the Aortic Valve Calcification Score(AVCS) Improvement of dyspnea according to the New York Heart Association Classification(NYHA) Improvement of the quality of life of the patients( physical activity, mobility) | 3 years | 
| Reduction of the Aortic Valve calcification measured by CT Scan | Reduction of the Aortic Valve Calcification Score (AVCS) | 3 years | 
| Improvement of dyspnea (at rest and effort) | Improvement of dyspnea according to the New York Heart Association Classification(NYHA) | 3 years | 
| Improvement of the quality of life of the patients | Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014 | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AVD