The Aortic Valve DECalcification (AVADEC) Trial

Not Applicable

Completed

• Conditions: Randomised Clinical Trial; Aortic Valve Stenosis; Multidetector Computed Tomography; Vitamin K 2
• Interventions: Dietary Supplement: Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).; Dietary Supplement: Placebo

• Registration Number: NCT03243890
• Lead Sponsor: Axel Diederichsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-09
• Study Start: 2018-01-12
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 389

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Aortic valve calcification	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 Outcome Measures

Name	Time	Method
Quality of life	From baseline to two years of follow-up	Change in quality of life
Coronary plaque composition	From baseline to two years of follow-up	Change in total plaque burden in the coronaries and carotid arteries by contrast CT
Aortic valve area	From baseline to two years of follow-up	Change in aortic valve area by transthoracic echocardiography
Bone mineral density	From baseline to two years of follow-up	Change in bone mineral density as quantitative CT of the columna lumbalis and hip region
Arterial calcification	From baseline to two years of follow-up	Change in compiled arterial calcification by non-contrast CT
Aortic size	From baseline to two years of follow-up	Change in aortic diameter
Biomarkers of calcification	From baseline to two years of follow-up	Change in matrix-Gla proteins and osteocalcin with different phosphorylation (p and dp) and carboxylation forms (c and uc).

Trial Locations

Locations (1)

Department of Cardiology, Odense University Hospital; 🇩🇰 Odense, Odense C, Denmark