Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial Design
BASIK2 is a prospective, double-blind, randomized placebo-controlled trial investigating the effect of vitamin K2 (menaquinone-7;MK7) on imaging measurements of calcification in the bicuspid aortic valve (BAV) and calcific aortic valve stenosis (CAVS). BAV is associated with early development of CAV...
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doaj-67413b8094f84256a3ca26d234aa1c9f2020-11-25T02:28:46ZengMDPI AGNutrients2072-66432018-03-0110438610.3390/nu10040386nu10040386Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial DesignFrederique E. C. M. Peeters0Manouk J. W. van Mourik1Steven J. R. Meex2Jan Bucerius3Simon M. Schalla4Suzanne C. Gerretsen5Casper Mihl6Marc R. Dweck7Leon J. Schurgers8Joachim E. Wildberger9Harry J. G. M. Crijns10Bas L. J. H. Kietselaer11Department of Cardiology, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The NetherlandsDepartment of Cardiology, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The NetherlandsDepartment of Clinical Chemistry, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, The NetherlandsDepartment of Radiology & Nuclear Medicine, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The NetherlandsDepartments of Cardiology and Radiology, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The NetherlandsDepartment of Radiology & Nuclear Medicine, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The NetherlandsDepartment of Radiology & Nuclear Medicine, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The NetherlandsCentre for Cardiovascular Science, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UKDepartment of Biochemistry, Maastricht University and CARIM, P.O. Box 616, 6200 MD Maastricht, The NetherlandsDepartment of Radiology & Nuclear Medicine, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The NetherlandsDepartment of Cardiology, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The NetherlandsDepartment of Cardiology, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The NetherlandsBASIK2 is a prospective, double-blind, randomized placebo-controlled trial investigating the effect of vitamin K2 (menaquinone-7;MK7) on imaging measurements of calcification in the bicuspid aortic valve (BAV) and calcific aortic valve stenosis (CAVS). BAV is associated with early development of CAVS. Pathophysiologic mechanisms are incompletely defined, and the only treatment available is valve replacement upon progression to severe symptomatic stenosis. Matrix Gla protein (MGP) inactivity is suggested to be involved in progression. Being a vitamin K dependent protein, supplementation with MK7 is a pharmacological option for activating MGP and intervening in the progression of CAVS. Forty-four subjects with BAV and mild–moderate CAVS will be included in the study, and baseline 18F-sodiumfluoride (18F-NaF) positron emission tomography (PET)/ magnetic resonance (MR) and computed tomography (CT) assessments will be performed. Thereafter, subjects will be randomized (1:1) to MK7 (360 mcg/day) or placebo. During an 18-month follow-up period, subjects will visit the hospital every 6 months, undergoing a second 18F-NaF PET/MR after 6 months and CT after 6 and 18 months. The primary endpoint is the change in PET/MR 18F-NaF uptake (6 months minus baseline) compared to this delta change in the placebo arm. The main secondary endpoints are changes in calcium score (CT), progression of the left ventricularremodeling response and CAVS severity (echocardiography). We will also examine the association between early calcification activity (PET) and later changes in calcium score (CT).http://www.mdpi.com/2072-6643/10/4/386bicuspid aortic valvecalcific aortic valve stenosisvitamin K2menaquinone-7PET/MR18F-NaF |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Frederique E. C. M. Peeters Manouk J. W. van Mourik Steven J. R. Meex Jan Bucerius Simon M. Schalla Suzanne C. Gerretsen Casper Mihl Marc R. Dweck Leon J. Schurgers Joachim E. Wildberger Harry J. G. M. Crijns Bas L. J. H. Kietselaer |
spellingShingle |
Frederique E. C. M. Peeters Manouk J. W. van Mourik Steven J. R. Meex Jan Bucerius Simon M. Schalla Suzanne C. Gerretsen Casper Mihl Marc R. Dweck Leon J. Schurgers Joachim E. Wildberger Harry J. G. M. Crijns Bas L. J. H. Kietselaer Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial Design Nutrients bicuspid aortic valve calcific aortic valve stenosis vitamin K2 menaquinone-7 PET/MR 18F-NaF |
author_facet |
Frederique E. C. M. Peeters Manouk J. W. van Mourik Steven J. R. Meex Jan Bucerius Simon M. Schalla Suzanne C. Gerretsen Casper Mihl Marc R. Dweck Leon J. Schurgers Joachim E. Wildberger Harry J. G. M. Crijns Bas L. J. H. Kietselaer |
author_sort |
Frederique E. C. M. Peeters |
title |
Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial Design |
title_short |
Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial Design |
title_full |
Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial Design |
title_fullStr |
Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial Design |
title_full_unstemmed |
Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial Design |
title_sort |
bicuspid aortic valve stenosis and the effect of vitamin k2 on calcification using 18f-sodium fluoride positron emission tomography/magnetic resonance: the basik2 rationale and trial design |
publisher |
MDPI AG |
series |
Nutrients |
issn |
2072-6643 |
publishDate |
2018-03-01 |
description |
BASIK2 is a prospective, double-blind, randomized placebo-controlled trial investigating the effect of vitamin K2 (menaquinone-7;MK7) on imaging measurements of calcification in the bicuspid aortic valve (BAV) and calcific aortic valve stenosis (CAVS). BAV is associated with early development of CAVS. Pathophysiologic mechanisms are incompletely defined, and the only treatment available is valve replacement upon progression to severe symptomatic stenosis. Matrix Gla protein (MGP) inactivity is suggested to be involved in progression. Being a vitamin K dependent protein, supplementation with MK7 is a pharmacological option for activating MGP and intervening in the progression of CAVS. Forty-four subjects with BAV and mild–moderate CAVS will be included in the study, and baseline 18F-sodiumfluoride (18F-NaF) positron emission tomography (PET)/ magnetic resonance (MR) and computed tomography (CT) assessments will be performed. Thereafter, subjects will be randomized (1:1) to MK7 (360 mcg/day) or placebo. During an 18-month follow-up period, subjects will visit the hospital every 6 months, undergoing a second 18F-NaF PET/MR after 6 months and CT after 6 and 18 months. The primary endpoint is the change in PET/MR 18F-NaF uptake (6 months minus baseline) compared to this delta change in the placebo arm. The main secondary endpoints are changes in calcium score (CT), progression of the left ventricularremodeling response and CAVS severity (echocardiography). We will also examine the association between early calcification activity (PET) and later changes in calcium score (CT). |
topic |
bicuspid aortic valve calcific aortic valve stenosis vitamin K2 menaquinone-7 PET/MR 18F-NaF |
url |
http://www.mdpi.com/2072-6643/10/4/386 |
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