Impact of oral vitamin K2 supplementation on blood and tissue biomarkers in patients with severe aortic valve stenosis

INTERVENTION: Group 1: Experimental intervention: Intake of one capsule with 1mg vitamin K2 (Menaquinone‐7) once daily for at least 6 weeks Group 2: Control intervention: Intake of one capsule placebo once daily for at least 6 weeks CONDITION: ; I35.0 ; I35.2 Aortic (valve) stenosis Aortic (valve) stenosis with insufficiency PRIMARY OUTCOME: Change in the concentration of circulating plasma levels of inactive Matrix‐Gla Protein (dp‐ucMGP) from baseline to Visit 2 (approx. 6‐12 weeks after start of vitamin K2/placebo intake), compared between the vitamin K2 group and the placebo group SECONDARY OUTCOME: Expression of pro‐calcific and inflammatory mediators on the mRNA and protein level and on circulating immune cells and (Immune)histological assessments of valve calcification and immune cell infiltration/activation INCLUSION CRITERIA: • The patient has given written consent to participate in the clinical trial. • Confirmed diagnosis of severe aortic valve stenosis • Indication for surgical aortic valve replacement by decision of the local Heart Team