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

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ClinicalTrials.gov Identifier: NCT03305536
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
Omicron Pharmaceuticals
Nattopharma ASA
Information provided by (Responsible Party):
Rodolph Frangi, 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.


Condition or disease Intervention/treatment Phase
Aortic Valve Disease Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: K2/D3




Primary Outcome Measures :
  1. Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg) [ Time Frame: 3 years ]
  2. Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2) [ Time Frame: 3 years ]
  3. Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification. [ Time Frame: 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)

  2. Reduction of the Aortic Valve calcification measured by CT Scan [ Time Frame: 3 years ]
    Reduction of the Aortic Valve Calcification Score (AVCS)

  3. Improvement of dyspnea (at rest and effort) [ Time Frame: 3 years ]
    Improvement of dyspnea according to the New York Heart Association Classification(NYHA)

  4. Improvement of the quality of life of the patients [ Time Frame: 3 years ]
    Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014



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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305536


Contacts
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Contact: Rodoplh Frangi, MD 00961 9 234 202 ext 1100 drfrangi@hotmail.com

Locations
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Lebanon
Hopital Saint-George Ajaltoun Recruiting
Beirut, Lebanon
Contact: Rodolphe Frangi, MD         
Sponsors and Collaborators
Hopital St. Georges, Ajaltoun
Omicron Pharmaceuticals
Nattopharma ASA

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Responsible Party: Rodolph Frangi, Head of Department of Thoracic and Cardiovascular surgery, Hopital St. Georges, Ajaltoun
ClinicalTrials.gov Identifier: NCT03305536     History of Changes
Other Study ID Numbers: NC27082017
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rodolph Frangi, Hopital St. Georges, Ajaltoun:
AVD
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Vitamin K
Vitamin K 2
Vitamin MK 7
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants