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

Aortic Valve Disease Clinical Trial

— DECAV-K2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03305536
• Other study ID #: NC27082017
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2, 2018
• Est. completion date: December 2020

Study information

• Verified date: August 2019
• Source: Hopital St. Georges, Ajaltoun
• Contact: Rodoplh Frangi, MD
• Phone: 00961 9 234 202
• Email: drfrangi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Dietary Supplement:
• Vitamin K2 (Menaquinone 7) + Vitamin D3
Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease

Locations

Country	Name	City	State
Lebanon	Hopital Saint-George Ajaltoun	Beirut

Sponsors (3)

Lead Sponsor	Collaborator
Hopital St. Georges, Ajaltoun	Nattopharma ASA, Omicron Pharmaceuticals

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)		3 years
Primary	Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)		3 years
Primary	Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)		3 years
Secondary	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
Secondary	Reduction of the Aortic Valve calcification measured by CT Scan	Reduction of the Aortic Valve Calcification Score (AVCS)	3 years
Secondary	Improvement of dyspnea (at rest and effort)	Improvement of dyspnea according to the New York Heart Association Classification(NYHA)	3 years
Secondary	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