Clinical trial NCT04429035: SLOW-Slower Progress of caLcificatiOn With Vitamin K2
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Valve Calcification
Mitral Annular Calcification
Mitral Valve Calcification
Mitral Valve Stenosis
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of calcification change of Aortic valve.Correlation With Mitral annulus and ascending Aorta calcification.A randomized 12-month trial.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: First Department of Cardiology, University of Athens
state: Attiki
city: Athens
country: Greece
facility: Hippokration Hospital 1st Department of Cardiology,National and Kapodistrian University of Athens,Medical School
state: Attiki
Study officials:
References: