SLOW-Slower Progress of caLcificatiOn With Vitamin K2

Not Applicable

• Conditions: Aortic Valve Stenosis; Aortic Valve Calcification; Mitral Valve Calcification; Mitral Annular Calcification; Mitral Valve Stenosis
• Interventions: Dietary Supplement: Vitamin K2; Dietary Supplement: Placebo

• Registration Number: NCT04429035
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA \> 1 cm2, Vmax \< 4 m/s). The first group of 100 individuals will serve as the intervention group that will receive 300 mcg of K2 vitamin on a daily basis, while the second group of 100 individuals will be the control group that will receive placebo on a daily basis as well. Both groups will be monitored identically in order to investigate therapeutic effects on calcification and valve stenosis progression. Correlation with Mitral annulus and ascending Aorta.Exclusion criteria: Chronic Kidney disease, Vitamin K antagonists, statins, age \< 50 y.o,prosthetic valves,Aortic Valve area (AVA) \< 1cm2 ,Vmax \> 4 m/s

Detailed Description

For the purposes of this study, all individuals will be subjected to the same quantitative and qualitative tests, before and after the daily administration of 300mcg K2 vitamin/placebo for a period of one year.Clinical examination,extensive blood laboratory tests,direct measurement of Dephosphorylated-uncarboxylated MGP(dp-ucMGP), Echocardiogram and ECS,carotid ultrasound,ophthalmologic exam,further imaging methods with MSCT Calcium Score(Agatston score) will take place.Correlations with their medical and pharmacological therapy history.

Before and after the administration of VK2/placebo, the following measurements will take place i)Quantitative and percentile rate determination of Aortic Valve, Mitral Valve and Ascending Aorta calcification via MSCT Calcium score without contrast.

ii)Echocardiogram and calcification evaluation via Echocardiographic Calcium Score (ECS), iii)Determination of changes in carotid intima-media thickness (cIMT) and Carotid stenosis iv)Standard ophthalmologic examination v)Direct measurement of Dephosphorylated-uncarboxylated MGP(dp-ucMGP) vi)Correlation with blood biomarkers

Study Timeline

• Study Start: 2019-09-23
• Study First Submitted: 2020-05-31
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2022-10-23
• Study Completion: 2023-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• ASYMPTOMATIC AV STENOSIS WITH AVA>1 cm2 & Vmax<4m/s

Exclusion Criteria

• AVK,STATINS,MSCT THE LAST 6 MONTHS,PROSTHETIC VALVES, AVA<1 cm2,Vmax>4m/s

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin K2	Vitamin K2	Participants receive Vitamin K2 (Menaquinone) 100mcg tablet orally 3 times daily for 12 months.
Placebo	Placebo	Participants receive Vitamin K2 (Menaquinone) placebo tablet matching Vitamin K2 (Menaquinone) orally 3 times daily for 12 months.

Primary Outcome Measures

Name	Time	Method
Evaluation of calcification change of Aortic valve.Correlation With Mitral annulus and ascending Aorta calcification.A randomized 12-month trial.	Each patient will be evaluated twice a year.Once before the administartion of VK2/Placebo and after a period of a 12 month administration of VK2/PLACEBO	The calcification change will be evaluated via a 64 MSCT scanner measuring the calcium via Agatston score, before and after administration of VK2/placebo.The following measurements will take place and after 12 months will be compared.

Trial Locations

Locations (2)

First Department of Cardiology, University of Athens; 🇬🇷 Athens, Attiki, Greece

Hippokration Hospital 1st Department of Cardiology,National and Kapodistrian University of Athens,Medical School; 🇬🇷 Athens, Attiki, Greece