SLOW-Slower Progress of caLcificatiOn With Vitamin K2

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Mitral Valve Calcification; Mitral Annular Calcification; Aortic Valve Stenosis; Mitral Valve Stenosis; Aortic Valve Calcification

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin K2

Study type: Interventional

Funder types: Other

Identifiers

NCT04429035

55461

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Vitamin K2

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin K2

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo