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Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI (BASIK2)

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ClinicalTrials.gov Identifier: NCT02917525
Recruitment Status : Unknown
Verified March 2018 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : September 28, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief Summary:

Early development of calcified aortic valve disease (CAVD) is a commonly occurring complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two leaflets instead of three). In general, CAVD is characterized by progressive narrowing of the aortic valve, with involvement of altered calcium metabolism. CAVD progression in fact may lead to necessity of valve replacement, since to date, no other therapies have been shown effective in the treatment of CAVD.

The primary objective of our study is to test the hypothesis that supplementation of vitamin K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of calcification.

In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2 or placebo group. To assess the calcification process in a detailed manner in these patients, a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride [NaF]) that has been shown to bind to regions of newly developing microcalcification in aortic valve tissue is used.

We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium score on CT and echocardiography after 18 months (secondary endpoints), when compared to placebo.


Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Bicuspid Aortic Valve Dietary Supplement: Vitamin K2 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI (BASIK2): a Pilot Study
Study Start Date : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin K
Drug Information available for: Menadione

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitamin K2
22 patients will receive 360ug Vitamin K2 daily during 18 months.
 Dietary Supplement: Vitamin K2
Placebo Comparator: Placebo
22 patients will receive placebo during 18 months.
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in aortic valve calcium metabolism [ Time Frame: Measured at baseline and 6 months ]
    Change in calcium metabolism, measured as uptake of the 18F-NaF tracer on a 18F-NaF PET/CMR scan


Secondary Outcome Measures :
  1. Change in aortic valve calcium score [ Time Frame: Measured at baseline, 6 and 18 months ]
    Change in aortic valve calcium score, measured on CT.

  2. Progression of aortic valve stenosis [ Time Frame: Measured at baseline, 6, 12 and 18 months ]
    Change of severity of aortic valve stenosis on echocardiography


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • known bicuspid aortic valve
  • calcified mild to moderate aortic valve stenosis on prior echocardiography
  • informed consent provided

Exclusion Criteria:

  • absence of calcified aortic valve stenosis on echocardiography
  • presence of severe aortic valve stenosis
  • history of aortic valve repair or replacement
  • accepted atrial fibrillation
  • use of oral anticoagulants
  • claustrophobia
  • presence of a pacemaker, ICD or ferromagnetic materials in the body
  • life expectancy <2 years
  • Pregnancy (current or wish for near future)
  • soy allergy
  • use of vitamin K-containing supplements
Contacts and Locations
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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): NCT02917525


Contacts
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Contact: Bas Kietselaer, M.D., PhD +31 (0)43 687 5096 b.kietselaer@mumc.nl

Locations
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Netherlands
Maastricht UMC Recruiting
Maastricht, Netherlands, 6202 AZ
Contact: Bas Kietselaer, M.D., PhD    +31 (0)43 3875093    b.kietselaer@mumc.nl   
Contact: Bas Kietselaer, M.D. PhD    +31 (0)43 3875093    b.kietselaer@mumc.nl   
Sub-Investigator: Frederique Peeters, MD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Bas Kietselaer, M.D. PhD Maastricht UMC
More Information
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02917525    
Other Study ID Numbers: METC152045
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Keywords provided by Maastricht University Medical Center:
Calcium metabolism
Matrix Gla Protein
Vitamin K2
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Vitamin K
Vitamin K 2
Vitamins
 Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants