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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.
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.
Introduction:
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.
Methods And Analysis:
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.
Ethics And Dissemination:
There 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.
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