The Aortic Valve DECalcification (AVADEC) Trial (AVADEC)

September 28, 2022 updated by: Axel Diederichsen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Odense C
      • Odense, Odense C, Denmark, DK-5000
        • Department of Cardiology, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 71 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Study drug. Supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day)
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).
Placebo Comparator: Placebo
Placebo tablet (no active treatment). The placebo tablet is matched to the study drug for taste, color, and size.
Dietary supplement: Placebo
Half of the patients are randomized to placebo treatment (no active treatment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From baseline to two years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial calcification
Time Frame: From baseline to two years of follow-up
Change in compiled arterial calcification by non-contrast CT
From baseline to two years of follow-up
Aortic size
Time Frame: From baseline to two years of follow-up
Change in aortic diameter
From baseline to two years of follow-up
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
From baseline to two years of follow-up
Aortic valve area
Time Frame: From baseline to two years of follow-up
Change in aortic valve area by transthoracic echocardiography
From baseline to two years of follow-up
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
From baseline to two years of follow-up
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).
From baseline to two years of follow-up
Quality of life
Time Frame: From baseline to two years of follow-up
Change in quality of life
From baseline to two years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axel Diederichsen

Investigators

  • Principal Investigator: Axel CP Diederichsen, PhD, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2018

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

August 2, 2017

First Submitted That Met QC Criteria

August 4, 2017

First Posted (Actual)

August 9, 2017

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVADEC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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