SLOW-Slower Progress of caLcificatiOn With Vitamin K2

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04429035

Collaborator

(none)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

100

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Aortic Valve Calcification Mitral Annular Calcification Mitral Valve Calcification Mitral Valve Stenosis	Dietary Supplement: Vitamin K2 Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Sep 23, 2019

Anticipated Primary Completion Date :

Oct 23, 2022

Anticipated Study Completion Date :

Dec 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin K2 Participants receive Vitamin K2 (Menaquinone) 100mcg tablet orally 3 times daily for 12 months.	Dietary Supplement: Vitamin K2 Administration of 300 μg Vitamin K2 (MQ7) daily p.o
Placebo Comparator: Placebo Participants receive Vitamin K2 (Menaquinone) placebo tablet matching Vitamin K2 (Menaquinone) orally 3 times daily for 12 months.	Dietary Supplement: Placebo Administration of 300 μg Vitamin K2 (MQ7) Placebo daily p.o

Arm

Intervention/Treatment

Experimental: Vitamin K2

Participants receive Vitamin K2 (Menaquinone) 100mcg tablet orally 3 times daily for 12 months.

Dietary Supplement: Vitamin K2

Administration of 300 μg Vitamin K2 (MQ7) daily p.o

Placebo Comparator: Placebo

Participants receive Vitamin K2 (Menaquinone) placebo tablet matching Vitamin K2 (Menaquinone) orally 3 times daily for 12 months.

Dietary Supplement: Placebo

Administration of 300 μg Vitamin K2 (MQ7) Placebo daily p.o

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Department of Cardiology, University of Athens	Athens	Attiki	Greece	11527
2	Hippokration Hospital 1st Department of Cardiology,National and Kapodistrian University of Athens,Medical School	Athens	Attiki	Greece	11527