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

Primary Purpose

Aortic Valve Disease

Status
Unknown status
Phase
Phase 2
Locations
Lebanon
Study Type
Interventional
Intervention
Vitamin K2 (Menaquinone 7) + Vitamin D3
Sponsored by
Hopital St. Georges, Ajaltoun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disease focused on measuring AVD

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Saint-George AjaltounRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interventional

interventional

Arm Description

1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve

5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study

Outcomes

Primary Outcome Measures

Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)

Secondary Outcome Measures

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)
Reduction of the Aortic Valve calcification measured by CT Scan
Reduction of the Aortic Valve Calcification Score (AVCS)
Improvement of dyspnea (at rest and effort)
Improvement of dyspnea according to the New York Heart Association Classification(NYHA)
Improvement of the quality of life of the patients
Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014

Full Information

First Posted
August 30, 2017
Last Updated
August 8, 2019
Sponsor
Hopital St. Georges, Ajaltoun
Collaborators
Omicron Pharmaceuticals, Nattopharma ASA
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1. Study Identification

Unique Protocol Identification Number
NCT03305536
Brief Title
Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
Acronym
DECAV-K2
Official Title
Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital St. Georges, Ajaltoun
Collaborators
Omicron Pharmaceuticals, Nattopharma ASA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease
Keywords
AVD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Active Comparator
Arm Description
1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve
Arm Title
interventional
Arm Type
Active Comparator
Arm Description
5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K2 (Menaquinone 7) + Vitamin D3
Other Intervention Name(s)
K2/D3
Intervention Description
Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease
Primary Outcome Measure Information:
Title
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)
Time Frame
3 years
Title
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
Time Frame
3 years
Title
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.
Description
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)
Time Frame
3 years
Title
Reduction of the Aortic Valve calcification measured by CT Scan
Description
Reduction of the Aortic Valve Calcification Score (AVCS)
Time Frame
3 years
Title
Improvement of dyspnea (at rest and effort)
Description
Improvement of dyspnea according to the New York Heart Association Classification(NYHA)
Time Frame
3 years
Title
Improvement of the quality of life of the patients
Description
Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodoplh Frangi, MD
Phone
00961 9 234 202
Ext
1100
Email
drfrangi@hotmail.com
Facility Information:
Facility Name
Hopital Saint-George Ajaltoun
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodolphe Frangi, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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