Aortic Valve Stenosis Clinical Trial
Official title:
Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI (BASIK2): a Pilot Study
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.
n/a
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