Clinical trial NCT03243890: The Aortic Valve DECalcification (AVADEC) Trial
Official title: The Effects of Menaquinone-7 Supplementation in Patients With Aortic Valves Calcification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Multidetector Computed Tomography
Vitamin K 2
Randomised Clinical Trial
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 389
Sex: MALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.


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

Primary outcomes:
measure: Aortic valve calcification
timeFrame: From baseline to two years of follow-up
Secondary outcomes:
measure: Arterial calcification
timeFrame: From baseline to two years of follow-up
measure: Aortic size
timeFrame: From baseline to two years of follow-up
measure: Coronary plaque composition
timeFrame: From baseline to two years of follow-up
measure: Aortic valve area
timeFrame: From baseline to two years of follow-up
measure: Bone mineral density
timeFrame: From baseline to two years of follow-up
measure: Biomarkers of calcification
timeFrame: From baseline to two years of follow-up
measure: Quality of life
timeFrame: From baseline to two years of follow-up
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Cardiology, Odense University Hospital
state: Odense C
Study officials:
affiliation: Odense University Hospital
name: Axel CP Diederichsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lindholt JS, Frandsen NE, Fredgart MH, Ovrehus KA, Dahl JS, Moller JE, Folkestad L, Urbonaviciene G, Becker SW, Lambrechtsen J, Auscher S, Hosbond S, Alan DH, Rasmussen LM, Gerke O, Mickley H, Diederichsen A. Effects of menaquinone-7 supplementation in patients with aortic valve calcification: study protocol for a randomised controlled trial. BMJ Open. 2018 Aug 23;8(8):e022019. doi: 10.1136/bmjopen-2018-022019.
citation: Diederichsen ACP, Lindholt JS, Moller S, Ovrehus KA, Auscher S, Lambrechtsen J, Hosbond SE, Alan DH, Urbonaviciene G, Becker SW, Fredgart MH, Hasific S, Folkestad L, Gerke O, Rasmussen LM, Moller JE, Mickley H, Dahl JS. Vitamin K2 and D in Patients With Aortic Valve Calcification: A Randomized Double-Blinded Clinical Trial. Circulation. 2022 May 3;145(18):1387-1397. doi: 10.1161/CIRCULATIONAHA.121.057008. Epub 2022 Apr 25.