Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI (BASIK2)
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|ClinicalTrials.gov Identifier: NCT02917525|
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : March 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis Bicuspid Aortic Valve||Dietary Supplement: Vitamin K2 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI (BASIK2): a Pilot Study|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Vitamin K2
22 patients will receive 360ug Vitamin K2 daily during 18 months.
Dietary Supplement: Vitamin K2
Placebo Comparator: Placebo
22 patients will receive placebo during 18 months.
- Change in aortic valve calcium metabolism [ Time Frame: Measured at baseline and 6 months ]Change in calcium metabolism, measured as uptake of the 18F-NaF tracer on a 18F-NaF PET/CMR scan
- Change in aortic valve calcium score [ Time Frame: Measured at baseline, 6 and 18 months ]Change in aortic valve calcium score, measured on CT.
- Progression of aortic valve stenosis [ Time Frame: Measured at baseline, 6, 12 and 18 months ]Change of severity of aortic valve stenosis on echocardiography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917525
|Contact: Bas Kietselaer, M.D., PhD||+31 (0)43 687 email@example.com|
|Maastricht, Netherlands, 6202 AZ|
|Contact: Bas Kietselaer, M.D., PhD +31 (0)43 3875093 firstname.lastname@example.org|
|Contact: Bas Kietselaer, M.D. PhD +31 (0)43 3875093 email@example.com|
|Sub-Investigator: Frederique Peeters, MD|
|Principal Investigator:||Bas Kietselaer, M.D. PhD||Maastricht UMC|