2. Academic Validation
  3. 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

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. 2018 Mar 21;10(4):386. doi: 10.3390/nu10040386.
Frederique E C M Peeters 1,  Manouk J W van Mourik 2,  Steven J R Meex 3,  Jan Bucerius 4 5,  Simon M Schalla 6,  Suzanne C Gerretsen 7,  Casper Mihl 8,  Marc R Dweck 9,  Leon J Schurgers 10,  Joachim E Wildberger 11,  Harry J G M Crijns 12,  Bas L J H Kietselaer 13 14
Affiliations

Affiliations

  • 1 Department of Cardiology, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. frederique.peeters@mumc.nl.
  • 2 Department of Cardiology, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. manouk.van.mourik@mumc.nl.
  • 3 Department of Clinical Chemistry, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. steven.meex@mumc.nl.
  • 4 Department of Radiology & Nuclear Medicine, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. jan.bucerius@mumc.nl.
  • 5 Department of Nuclear Medicine University Hospital RWTH Aachen, Pauwelsstraße 30, 52074 Aachen, Germany. jan.bucerius@mumc.nl.
  • 6 Departments of Cardiology and Radiology, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. s.schalla@mumc.nl.
  • 7 Department of Radiology & Nuclear Medicine, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. s.gerretsen@mumc.nl.
  • 8 Department of Radiology & Nuclear Medicine, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. casper.mihl@mumc.nl.
  • 9 Centre for Cardiovascular Science, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK. marc.dweck@ed.ac.uk.
  • 10 Department of Biochemistry, Maastricht University and CARIM, P.O. Box 616, 6200 MD Maastricht, The Netherlands. l.schurgers@maastrichtuniversity.nl.
  • 11 Department of Radiology & Nuclear Medicine, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. j.wildberger@mumc.nl.
  • 12 Department of Cardiology, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. hjgm.crijns@mumc.nl.
  • 13 Department of Cardiology, Maastricht University Medical Center+ and CARIM, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. b.kietselaer@zuyderland.nl.
  • 14 Department of Cardiology, Zuyderland Medisch Centrum Heerlen/Sittard, Henri Dunantstraat 5, 6419 PC Heerlen, The Netherlands. b.kietselaer@zuyderland.nl.
PMID: 29561783 DOI: 10.3390/nu10040386
Abstract

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).

Keywords

18F-NaF; PET/MR; bicuspid aortic valve; calcific aortic valve stenosis; menaquinone-7; vitamin K2.

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