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BMJ Open. 2018 Aug 23;8(8):e022019. doi: 10.1136/bmjopen-2018-022019.

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

Author information

1
Department of Cardiothoracic and Vascular Surgery, Odense Universitetshospital, Odense, Denmark.
2
Centre for Individualized Medicine in Arterial Diseases, Odense Universitetshospital, Odense, Denmark.
3
Kirkestenten 16, Skt Klemens, Odense C, Denmark.
4
Department of Cardiology, Odense Universitetshospital, Odense, Denmark.
5
Department of Endocrinology, Odense Universitetshospital, Odense, Denmark.
6
Department of Cardiology, Silkeborg Hospital, Silkeborg, Denmark.
7
Department of Cardiology, Svendborg Sygehus, Svendborg, Syddanmark, Denmark.
8
Department of Cardiology, Vejle Hospital, Vejle, Denmark.
9
Department of Clinical Biochemistry and Pharmacology, Odense Universitetshospital, Odense, Denmark.
10
Department of Nuclear Medicine, Odense Universitetshospital, Odense C, Denmark.

Abstract

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.

KEYWORDS:

aortic valve calcification; cardiovascular imaging; menaquinone-7; randomized clinical trial; valvular heart disease

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