SLOW-Slower Progress of caLcificatiOn With Vitamin K2

Aortic Valve Stenosis Clinical Trial

Official title:

Inhibition of Aortic Valve Calcification Through the Carboxylation Mechanism of Matrix Gla Protein (MGP), Following Administration of Vitamin K2 (Menaquinone-7). Correlation With Mitral Annulus and Ascending Aorta Calcification.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04429035
• Other study ID #: 55461
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: December 23, 2023

Study information

• Verified date: August 2021
• Source: National and Kapodistrian University of Athens
• Contact: Symeon Evangelos Mavroudeas, MD
• Phone: 00306948694644
• Email: akis-m[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 23, 2023
• Est. primary completion date: October 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Calcification
• Aortic Valve Stenosis
• Calcinosis
• Constriction, Pathologic
• Mitral Annular Calcification
• Mitral Valve Calcification
• Mitral Valve Stenosis

Intervention

Dietary Supplement:
• Vitamin K2
Administration of 300 µg Vitamin K2 (MQ7) daily p.o
• Placebo
Administration of 300 µg Vitamin K2 (MQ7) Placebo daily p.o

Locations

Country	Name	City	State
Greece	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

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of calcification change of Aortic valve.Correlation With Mitral annulus and ascending Aorta calcification.A randomized 12-month trial.	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.	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