We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- 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.
- Authors
Peeters, Frederique E. C. M.; van Mourik, Manouk J. W.; Meex, Steven J. R.; Bucerius, Jan; Schalla, Simon M.; Gerretsen, Suzanne C.; Mihl, Casper; Dweck, Marc R.; Schurgers, Leon J.; Wildberger, Joachim E.; Crijns, Harry J. G. M.; Kietselaer, Bas L. J. H.
- 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).
- Subjects
AORTIC stenosis; CALCINOSIS; AORTIC valve; CALCIUM; DEOXY sugars; ECHOCARDIOGRAPHY; PROSTHETIC heart valves; LONGITUDINAL method; MAGNETIC resonance imaging; RADIOPHARMACEUTICALS; POSITRON emission tomography; VITAMIN K; VENTRICULAR remodeling; RANDOMIZED controlled trials; BLIND experiment; DISEASE progression; OSTEOCALCIN; DIAGNOSIS
- Publication
Nutrients, 2018, Vol 10, Issue 4, p386
- ISSN
2072-6643
- Publication type
Article
- DOI
10.3390/nu10040386