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The Aortic Valve DECalcification (AVADEC) Trial

NCT03243890 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2022-09-29

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

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).

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Axel Diederichsen

    lead OTHER

Principal Investigators

  • Axel CP Diederichsen, PhD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-12
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243890 on ClinicalTrials.gov