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

Phase 2

• Conditions: Aortic Valve Disease
• Interventions: Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3

• Registration Number: NCT03305536
• Lead Sponsor: Hopital St. Georges, Ajaltoun

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:

1. 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3

2. 5000 IU/d Vitamin D3 as a control group

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-10-08
• Study First Posted: 2017-10-10
• Study Start: 2018-01-02
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• AVCS > 300 without aortic valve stenosis requiring operation

• Focus on patients with:

  1. Bicuspid aortic valve
  2. Dialysis or CKD
  3. Statin treatment

Exclusion Criteria

• Use of Vitamin K antagonist
• Malabsorption Problem
• LVEF < 40%
• A life expectancy < 3 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interventional	Vitamin K2 (Menaquinone 7) + Vitamin D3	5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study
Interventional	Vitamin K2 (Menaquinone 7) + Vitamin D3	1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve

Primary Outcome Measures

Name	Time	Method
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
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)	3 years

Secondary Outcome Measures

Name	Time	Method
Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.	3 years	1. Lowering of dephosphorelated-undercarboxylated matrix Gla protein (dp-ucMGP picomol/l); 2. Reduction of the Aortic Valve Calcification Score(AVCS); 3. Improvement of dyspnea according to the New York Heart Association Classification(NYHA); 4. Improvement of the quality of life of the patients( physical activity, mobility)
Improvement of the quality of life of the patients	3 years	Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014
Improvement of dyspnea (at rest and effort)	3 years	Improvement of dyspnea according to the New York Heart Association Classification(NYHA)
Reduction of the Aortic Valve calcification measured by CT Scan	3 years	Reduction of the Aortic Valve Calcification Score (AVCS)

Trial Locations

Locations (1)

Hopital Saint-George Ajaltoun; 🇱🇧 Beirut, Lebanon