The Aortic Valve DECalcification (AVADEC) Trial

Axel Diederichsen389 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

389

Conditions

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

Eligibility

Sex: MALEMin age: 65 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Aortic valve calcification

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).