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

Last updated: August 8, 2019
Sponsor: Hopital St. Georges, Ajaltoun
Overall Status: Active - Recruiting

Phase

2

Condition

Heart Valve Disease

Treatment

N/A

Clinical Study ID

NCT03305536
NC27082017
  • Ages 30-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Use of Vitamin K antagonist

  • Malabsorption Problem

  • LVEF < 40%

  • A life expectancy < 3 years

Study Design

Total Participants: 150
Study Start date:
January 02, 2018
Estimated Completion Date:
December 31, 2020

Study 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

Connect with a study center

  • Hopital Saint-George Ajaltoun

    Beirut,
    Lebanon

    Active - Recruiting

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