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Completed

NCT Number: NCT03243890

The Aortic Valve DECalcification (AVADEC) Trial

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Multidetector Computed Tomography Randomised Clinical Trial Ventricular Outflow Obstruction Vitamin K 2

Age range

65 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Odense University Hospital

Odense, Odense C, DK-5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).

Dietary Supplement

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).

Placebo

Dietary Supplement

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

Primary outcomes

  1. Aortic valve calcification

    Time frame: 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 outcomes

  1. Arterial calcification

    Time frame: From baseline to two years of follow-up

    Change in compiled arterial calcification by non-contrast CT

  2. Aortic size

    Time frame: From baseline to two years of follow-up

    Change in aortic diameter

  3. Coronary plaque composition

    Time frame: From baseline to two years of follow-up

    Change in total plaque burden in the coronaries and carotid arteries by contrast CT

  4. Aortic valve area

    Time frame: From baseline to two years of follow-up

    Change in aortic valve area by transthoracic echocardiography

  5. Bone mineral density

    Time frame: From baseline to two years of follow-up

    Change in bone mineral density as quantitative CT of the columna lumbalis and hip region

  6. Biomarkers of calcification

    Time frame: 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).

  7. Quality of life

    Time frame: From baseline to two years of follow-up

    Change in quality of life

Sponsors and collaborators

Lead sponsor

Axel Diederichsen

Other

Registry information

Official study title

The Effects of Menaquinone-7 Supplementation in Patients With Aortic Valves Calcification

Acronym: AVADEC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2017
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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