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

BMJ Open
Jes Sanddal LindholtAxel Diederichsen

Abstract

Aortic 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. In 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. There are no reported adverse effects associated with the use o...Continue Reading

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Citations

Mar 13, 2020·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·Lu DaiPeter Stenvinkel
May 4, 2020·European Heart Journal Cardiovascular Imaging·Pernille Stegemejer SønderskovAnd Axel Diederichsen
Aug 28, 2019·International Journal of Molecular Sciences·Dina C SimesCatarina Marreiros
Oct 30, 2020·PloS One·Selma HasificAxel Diederichsen
Nov 8, 2020·International Journal of Molecular Sciences·Maristella DonatoMarcello Rattazzi

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Methods Mentioned

BETA
ELISA

Clinical Trials Mentioned

NCT03243890

Software Mentioned

DANCAVAS
Research Electronic Data Capture
AVADEC
Mindways

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