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

Jes Sanddal Lindholt1,2, Niels Erik Frandsen3, Maise Høigaard Fredgart4

  • 1Department of Cardiothoracic and Vascular Surgery, Odense Universitetshospital, Odense, Denmark.

BMJ Open
|August 25, 2018
PubMed

Insights

This study investigated if menaquinone-7 (MK-7) supplementation slows aortic valve calcification (AVC) progression in older men. Results will determine if MK-7 offers a new preventive strategy for this common heart valve disease.

Area of Science:

  • Cardiology
  • Nutritional Science
  • Medical Research

Background:

  • Aortic stenosis is a prevalent heart valve disease, increasing with the aging population.
  • Current treatment for aortic stenosis is primarily surgical, with limited medical preventive options.
  • Aortic valve calcification (AVC) is a progressive feature of aortic stenosis.

Purpose of the Study:

  • To evaluate the effect of menaquinone-7 (MK-7) supplementation on the progression of aortic valve calcification (AVC).
  • To test the hypothesis that MK-7 slows down the calcification process in the aortic valve.

Main Methods:

  • A multicenter, double-blinded, placebo-controlled study involving 400 men aged 65-74 years with substantial AVC.
  • Participants received either MK-7 (720 µg/day) plus vitamin D (25 µg/day) or a placebo for 2 years.
  • Aortic valve calcification (AVC) scores were assessed using non-contrast CT scans at baseline and 12/24 months.

Main Results:

  • The primary outcome is the difference in AVC score from baseline to 2-year follow-up.
  • Intention-to-treat analysis will be used for all outcome assessments.
  • No adverse effects of MK-7 are reported in the study protocol.

Conclusions:

  • The study aims to determine if MK-7 supplementation can be a viable medical intervention to slow AVC progression.
  • Findings will contribute to understanding potential non-surgical treatments for aortic stenosis.
  • The study adheres to ethical guidelines and will report all findings.
Abstract

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