The Aortic Valve DECalcification (AVADEC) Trial

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

NCT03243890

AVADEC

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

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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