Effects of menaquinone-7 supplementation in patients with aortic valve calcification: study protocol for a randomised controlled trial

摘要: Introduction Aortic stenosis is a common heart valve disease, and due to the growing elderly population, prevalence increasing. The disease progressive with increasing calcification of cusps. A few attempts medical preventive treatment have failed; thus, presently, only effective aortic surgery. This study will examine effect menaquinone-7 (MK-7) supplementation on progression (AVC). We hypothesise that MK-7 slow down process. Methods analysis In this multicenter double-blinded, placebo-controlled study, 400 men aged 65-74 years substantial AVC are randomised (1:1) (720 µg/day) supplemented by recommended daily dose vitamin D (25 or placebo (no active treatment) for 2 years. Exclusion criteria K antagonist coagulation disorders. To evaluate score, non-contrast CT scan performed at baseline repeated after 12 24 months follow-up. Primary outcome difference in score from follow-up Intention-to-treat principle used all analyses. Ethics dissemination There no reported adverse effects associated use MK-7. protocol approved Regional Scientific Ethical Committee Southern Denmark (S-20170059) Data Protection Agency (17/19010). It conducted accordance Declaration Helsinki. Positive as well negative findings be reported. Trial registration number NCT03243890.