Journal Article

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

Lambrechtsen, Jess, Folkestad, Lars, Lindholt, Jes Sanddal, Frandsen, Niels Erik, Mickley, Hans, Dahl, Jordi Sanchez, Øvrehus, Kristian A, Urbonaviciene, Grazina, Auscher, Søren, Rasmussen, Lars Melholt, Becker, Søren Warberg, Gerke, Oke, Fredgart, Maise Høigaard, Hosbond, Susanne, Diederichsen, Axel, Møller, Jacob Eifer, Alan, Dilek Hunerel

2018

Overview

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

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Aged / Aortic Valve - diagnostic imaging / Aortic Valve - pathology / Aortic Valve Stenosis - diagnostic imaging / Aortic Valve Stenosis - drug therapy / Atherosclerosis / Calcification / Calcinosis - diagnostic imaging / Calcinosis - drug therapy / Cardiovascular disease / Cardiovascular Medicine / Coronary vessels / Disease Progression / Evidence-based medicine / Heart / Hemodialysis / Hemostatics - therapeutic use / Humans / Hypotheses / Male / Medical imaging / Multicenter Studies as Topic / Proteins / Randomized Controlled Trials as Topic / Tomography, X-Ray Computed / Veins & arteries / Vitamin K 2 - analogs & derivatives / Vitamin K 2 - therapeutic use / Women