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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Valve Stenosis Bicuspid Aortic Valve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin K2

22 patients will receive 360ug Vitamin K2 daily during 18 months.

Group Type EXPERIMENTAL

Vitamin K2

Intervention Type DIETARY_SUPPLEMENT

Placebo

22 patients will receive placebo during 18 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Vitamin K2

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No