Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI (BASIK2)
Primary Purpose
Aortic Valve Stenosis, Bicuspid Aortic Valve
Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Vitamin K2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Calcium metabolism, Matrix Gla Protein, Vitamin K2
Eligibility Criteria
Inclusion Criteria:
- known bicuspid aortic valve
- calcified mild to moderate aortic valve stenosis on prior echocardiography
- informed consent provided
Exclusion Criteria:
- absence of calcified aortic valve stenosis on echocardiography
- presence of severe aortic valve stenosis
- history of aortic valve repair or replacement
- accepted atrial fibrillation
- use of oral anticoagulants
- claustrophobia
- presence of a pacemaker, ICD or ferromagnetic materials in the body
- life expectancy <2 years
- Pregnancy (current or wish for near future)
- soy allergy
- use of vitamin K-containing supplements
Sites / Locations
- Maastricht UMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin K2
Placebo
Arm Description
22 patients will receive 360ug Vitamin K2 daily during 18 months.
22 patients will receive placebo during 18 months.
Outcomes
Primary Outcome Measures
Change in aortic valve calcium metabolism
Change in calcium metabolism, measured as uptake of the 18F-NaF tracer on a 18F-NaF PET/CMR scan
Secondary Outcome Measures
Change in aortic valve calcium score
Change in aortic valve calcium score, measured on CT.
Progression of aortic valve stenosis
Change of severity of aortic valve stenosis on echocardiography
Full Information
NCT ID
NCT02917525
First Posted
September 26, 2016
Last Updated
March 21, 2018
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02917525
Brief Title
Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI
Acronym
BASIK2
Official Title
Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI (BASIK2): a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Early development of calcified aortic valve disease (CAVD) is a commonly occurring complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two leaflets instead of three). In general, CAVD is characterized by progressive narrowing of the aortic valve, with involvement of altered calcium metabolism. CAVD progression in fact may lead to necessity of valve replacement, since to date, no other therapies have been shown effective in the treatment of CAVD.
The primary objective of our study is to test the hypothesis that supplementation of vitamin K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of calcification.
In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2 or placebo group. To assess the calcification process in a detailed manner in these patients, a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride [NaF]) that has been shown to bind to regions of newly developing microcalcification in aortic valve tissue is used.
We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium score on CT and echocardiography after 18 months (secondary endpoints), when compared to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Bicuspid Aortic Valve
Keywords
Calcium metabolism, Matrix Gla Protein, Vitamin K2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin K2
Arm Type
Experimental
Arm Description
22 patients will receive 360ug Vitamin K2 daily during 18 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
22 patients will receive placebo during 18 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K2
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in aortic valve calcium metabolism
Description
Change in calcium metabolism, measured as uptake of the 18F-NaF tracer on a 18F-NaF PET/CMR scan
Time Frame
Measured at baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in aortic valve calcium score
Description
Change in aortic valve calcium score, measured on CT.
Time Frame
Measured at baseline, 6 and 18 months
Title
Progression of aortic valve stenosis
Description
Change of severity of aortic valve stenosis on echocardiography
Time Frame
Measured at baseline, 6, 12 and 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
known bicuspid aortic valve
calcified mild to moderate aortic valve stenosis on prior echocardiography
informed consent provided
Exclusion Criteria:
absence of calcified aortic valve stenosis on echocardiography
presence of severe aortic valve stenosis
history of aortic valve repair or replacement
accepted atrial fibrillation
use of oral anticoagulants
claustrophobia
presence of a pacemaker, ICD or ferromagnetic materials in the body
life expectancy <2 years
Pregnancy (current or wish for near future)
soy allergy
use of vitamin K-containing supplements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bas Kietselaer, M.D., PhD
Phone
+31 (0)43 687 5096
Email
b.kietselaer@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bas Kietselaer, M.D. PhD
Organizational Affiliation
Maastricht UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht UMC
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bas Kietselaer, M.D., PhD
Phone
+31 (0)43 3875093
Email
b.kietselaer@mumc.nl
First Name & Middle Initial & Last Name & Degree
Bas Kietselaer, M.D. PhD
Phone
+31 (0)43 3875093
Email
b.kietselaer@mumc.nl
First Name & Middle Initial & Last Name & Degree
Frederique Peeters, MD
12. IPD Sharing Statement
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Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI
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