The Aortic Valve DECalcification (AVADEC) Trial (AVADEC)
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|ClinicalTrials.gov Identifier: NCT03243890|
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis Multidetector Computed Tomography Vitamin K 2 Randomised Clinical Trial||Dietary Supplement: Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day). Dietary Supplement: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The randomization-list is available to the data and safety monitoring board, but patients, nurses, physicians and other data collectors are kept blinded to the allocation during the study.|
|Official Title:||The Effects of Menaquinone-7 Supplementation in Patients With Aortic Valves Calcification|
|Actual Study Start Date :||January 12, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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).
- 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).
- Arterial calcification [ Time Frame: From baseline to two years of follow-up ]Change in compiled arterial calcification by non-contrast CT
- Coronary and carotid 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
- Aortic valve area [ Time Frame: From baseline to two years of follow-up ]Change in aortic valve area by transthoracic echocardiography
- 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
- 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).
- Quality of life [ Time Frame: From baseline to two years of follow-up ]Change in quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243890
|Department of Cardiology, Odense University Hospital|
|Odense, Odense C, Denmark, DK-5000|
|Principal Investigator:||Axel CP Diederichsen, PhD||Odense University Hospital|