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The Aortic Valve DECalcification (AVADEC) Trial

A

Axel Diederichsen

Status

Completed

Conditions

Vitamin K 2
Randomised Clinical Trial
Aortic Valve Stenosis
Multidetector Computed Tomography

Treatments

Dietary Supplement: Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

389 patients

Sex

Male

Ages

65 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

389 participants in 2 patient groups, including a placebo group

Intervention
Experimental group
Description:
Study drug. Supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day)
Treatment:
Dietary Supplement: Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).
Placebo
Placebo Comparator group
Description:
Placebo tablet (no active treatment). The placebo tablet is matched to the study drug for taste, color, and size.
Treatment:
Dietary Supplement: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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