NCT04429035

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2023

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

3.1 years

First QC Date

May 31, 2020

Last Update Submit

August 31, 2021

Conditions

Aortic Valve StenosisAortic Valve CalcificationMitral Annular CalcificationMitral Valve CalcificationMitral Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Vitamin K2

EXPERIMENTAL

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

Dietary Supplement: Vitamin K2

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Vitamin K2DIETARY_SUPPLEMENT

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

Vitamin K2
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

First Department of Cardiology, University of Athens

Athens, Attica, 11527, Greece

RECRUITING

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

Athens, Attica, 11527, Greece

RECRUITING

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve, Calcification ofMitral Valve Stenosis

Interventions

Vitamin K 2

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Vitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Central Study Contacts

Symeon Evangelos Mavroudeas, MD

CONTACT

00306948694644akis-m@hotmail.com

Konstantinos P Toutouzas, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

May 31, 2020

First Posted

June 11, 2020

Study Start

September 23, 2019

Primary Completion

October 23, 2022

Study Completion

December 23, 2023

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

GR(2)