The Aortic Valve DECalcification (AVADEC) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-12

Study Completion Date

2021-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized 1:1 after stratiﬁcation for site, AVC score (300-599 or ≥600) and statin-use. Each site will be provided with sequentially numbered, opaque and sealed envelopes containing randomly generated treatment allocations. Four different types of envelopes are provided; 1) AVC 300-599, no statin-use; 2) AVC 300-599, statin-use; 3) AVC ≥600, no statin-use; and 4) AVC ≥600, statin-use.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Intervention

Study drug. Supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day)

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Half of the patients are randomized to supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day).

Placebo

Placebo tablet (no active treatment). The placebo tablet is matched to the study drug for taste, color, and size.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Half of the patients are randomized to placebo treatment (no active treatment).

Interventions

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

Half of the patients are randomized to supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day).

Intervention Type DIETARY_SUPPLEMENT

Placebo

Half of the patients are randomized to placebo treatment (no active treatment).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No