The Effects of Menaquinone-7 Supplementation in Patients With Aortic Valves Calcification
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 389
- Locations
- 1
- Primary Endpoint
- Aortic valve calcification
Study Overview
Brief Summary
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). The investigators hypothesize that MK-7 supplementation will slow down the calcification process.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The randomization-list is available to the data and safety monitoring board, but patients, nurses, physicians and other data collectors are kept blinded to the allocation during the study.
Eligibility Criteria
- Ages
- 65 Years to 75 Years (Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants in the Danish Cardiovascular Screening Trial (Trials. 2015 Dec 5;16:554) with an aortic valve calcification score above 300, but without aortic valve stenosis are eligible.
Exclusion Criteria
- •Known aortic valve disease (peak velocity ≥3.0 m/s)
- •History of venous thrombosis or other coagulation disorders or use of vitamin K antagonists
- •Disorders of calcium and phosphate metabolism
- •A life-expectancy < 5 years
Arms & Interventions
Placebo
Placebo tablet (no active treatment). The placebo tablet is matched to the study drug for taste, color, and size.
Intervention: Placebo (Dietary Supplement)
Intervention
Study drug. Supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day)
Intervention: Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day). (Dietary Supplement)
Outcomes
Primary Outcomes
Aortic valve calcification
Time Frame: From baseline to two years of follow-up
The primary endpoint is the change in aortic valve calcification. The natural history of the aortic valve calcification is not adequately understood, and accordingly the changes are analyzed in two prespecified patient subgroups (AVC score 300-599 and ≥600, respectively).
Secondary Outcomes
- Quality of life(From baseline to two years of follow-up)
- Coronary plaque composition(From baseline to two years of follow-up)
- Aortic valve area(From baseline to two years of follow-up)
- Bone mineral density(From baseline to two years of follow-up)
- Arterial calcification(From baseline to two years of follow-up)
- Aortic size(From baseline to two years of follow-up)
- Biomarkers of calcification(From baseline to two years of follow-up)
Investigators
Axel Diederichsen
Associated professor
Odense University Hospital