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SLOW-Slower Progress of caLcificatiOn With Vitamin K2

NCT ID: NCT04429035

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-23

Study Completion Date

2023-12-23

Brief Summary

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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

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Detailed Description

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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

Conditions

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Aortic Valve Stenosis Aortic Valve Calcification Mitral Annular Calcification Mitral Valve Calcification Mitral Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin K2

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

Group Type EXPERIMENTAL

Vitamin K2

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin K2

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Konstantinos Toutouzas

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First Department of Cardiology, University of Athens

Athens, Attica, Greece

Site Status RECRUITING

Hippokration Hospital 1st Department of Cardiology,National and Kapodistrian University of Athens,Medical School

Athens, Attica, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Symeon Evangelos Mavroudeas, MD

Role: CONTACT

[email protected]
00306948694644

Konstantinos P Toutouzas, Professor

Role: CONTACT

Facility Contacts

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Konstantinos P Toutouzas, Professor

Role: primary

[email protected]
00302132088147

Symeon Evangelos Mavroudeas, MD

Role: backup

[email protected]
00306948694644

Other Identifiers

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55461

Identifier Type: -

Identifier Source: org_study_id

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