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

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Dietary supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • Hopital Saint-George Ajaltoun
    • Contact: Rodolphe Frangi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interventional; 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; Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease; Other Names: K2/D3
Active Comparator: interventional; 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; Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease; Other Names: K2/D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hopital St. Georges, Ajaltoun
• Collaborators: Omicron Pharmaceuticals; Nattopharma ASA

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: October 8, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: AVD
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Micronutrients; Bone Density Conservation Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin D; Vitamin K; Vitamins; Vitamin K 2; Vitamin MK 7
• Other Study ID Numbers: NC27082017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No