TY - JOUR
T1 - Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using F-18-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance
T2 - The BASIK2 Rationale and Trial Design
AU - Peeters, Frederique E. C. M.
AU - van Mourik, Manouk J. W.
AU - Meex, Steven J. R.
AU - Bucerius, Jan
AU - Schalla, Simon M.
AU - Gerretsen, Suzanne C.
AU - Mihl, Casper
AU - Dweck, Marc R.
AU - Schurgers, Leon J.
AU - Wildberger, Joachim E.
AU - Crijns, Harry J. G. M.
AU - Kietselaer, Bas L. J. H.
PY - 2018/4/1
Y1 - 2018/4/1
N2 - 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 F-18-sodiumfluoride (F-18-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 F-18-NaF PET/MR after 6 months and CT after 6 and 18 months. The primary endpoint is the change in PET/MR F-18-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).
AB - 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 F-18-sodiumfluoride (F-18-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 F-18-NaF PET/MR after 6 months and CT after 6 and 18 months. The primary endpoint is the change in PET/MR F-18-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).
KW - bicuspid aortic valve
KW - calcific aortic valve stenosis
KW - vitamin K2
KW - menaquinone-7
KW - PET/MR
KW - F-18-NaF
KW - MATRIX GLA-PROTEIN
KW - CORONARY-HEART-DISEASE
KW - EUROPEAN-ASSOCIATION
KW - RANDOMIZED-TRIAL
KW - MENAQUINONE-7 SUPPLEMENTATION
KW - ECHOCARDIOGRAPHIC-ASSESSMENT
KW - AMERICAN-SOCIETY
KW - PROGRESSION
KW - RECOMMENDATIONS
KW - CARDIOLOGY
U2 - 10.3390/nu10040386
DO - 10.3390/nu10040386
M3 - Article
C2 - 29561783
VL - 10
JO - Nutrients
JF - Nutrients
SN - 2072-6643
IS - 4
M1 - 386
ER -