Bicuspid aortic valve stenosis and the effect of vItamin K2 on calciummetabolism on 18F-NaF PET/MRI (BASIK2): a pilot study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 44

Inclusion Criteria

Known with a bicuspid aortic valve and,
Calcified mild to moderate aortic valve stenosis on prior echocardiography
Age older than 18 years
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 aortic valve replacement , scheduled for aortic valve replacement or repair , accepted atrial fibrillation, use of oral anticoagulants, claustrophobia, presence of a pacemaker or ICD or ferromagnetic materials in the body, adipositas permagna, history of (non treated) cancer within the previous two years (excep non-melanoma skin cancer, carcinomas or in situ carcinoma of cervix), life expectancy of less than 2 years, wish for near future, or present pregnancy, breast feeding, (active) metabolic or gastrointestinal disease not controlled by current treatment, (history of) soy allergy, use of vitamin K-containing supplements, chronic inflammatory disease, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, corticoid treatment, participation in a clinical study more recently than one month before the current study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the difference in (the mean of) the<br /><br>maximal uptake of 18F-NaF tracer of the aortic valve between the intervention<br /><br>group and the control group after 6 months on 18F-NaF PET/CMR-scan. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the difference in mean calcium mass score<br /><br>progression of the aortic valve between the intervention group and the control<br /><br>group after 6 and 18 months on non-contrast CT-scan, whether the primary<br /><br>endpoint predicts or correlates with the results in calcium mass score after 6<br /><br>and 18 months, whether supplementation with Vitamin K2 reduces progression of<br /><br>aortic valve stenosis, whether it is associated with altered aortic<br /><br>distensibility and flow, whether it is associated with reduced impairment of<br /><br>left ventricular (LV) function, whether serum biomarker values might predict<br /><br>long term diastolic function and whether more AVRs occur in the control group.</p><br>