Brief Title
The Aortic Valve DECalcification (AVADEC) Trial
Official Title
The Effects of Menaquinone-7 Supplementation in Patients With Aortic Valves Calcification
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.
Study Type
Interventional
Primary Outcome
Aortic valve calcification
Secondary Outcome
Arterial calcification
Condition
Aortic Valve Stenosis
Intervention
Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).
Study Arms / Comparison Groups
Intervention
Description: Study drug. Supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
389
Start Date
January 12, 2018
Completion Date
May 1, 2021
Primary Completion Date
May 1, 2021
Eligibility Criteria
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
Gender
Male
Ages
65 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Axel CP Diederichsen, PhD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT03243890
Organization ID
AVADEC
Responsible Party
Sponsor-Investigator
Study Sponsor
Axel Diederichsen
Study Sponsor
Axel CP Diederichsen, PhD, Principal Investigator, Odense University Hospital
Verification Date
August 2021