Treatment to reduce vascular calcification in hemodialysis patients using vitamin K (Trevasc-HDK)

Abstract

Introduction:EndstagerenalfailurepatientsonhemodialysishavesignificantvascularcalcificationThisispostulatedtoberelated to sub-clinical vitamin K deficiency, which is prevalent in hemodialysis patients. Vitamin K deficiency result in the failure of the matrix GLA protein (MGP) to undergo carboxylation. MGP is a natural local inhibitor of vascular calcification and the lack of functional carboxylatedMGPmaycontributetoincreasevascularcalcification.VitaminKsupplementshouldthereforecorrectthisanomalyand decreasetherateorseverityofvascularcalcificationinthispopulationofpatientsonlong-termmaintenancehemodialysis.Ourstudy seekstoevaluatetheprevalenceandtheprogressionofvascularcalcificationinacohortofmaintenancehemodialysispatients.Itwill also evaluate the efficacy of vitamin K supplementation in reducing the progression of vascular calcification in this group of patients. Methods:This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patientsonhemodialysis.Weaimtorecruit200patients.Eligiblepatientswillberandomizedtoeitherthestandardcarearmoractive treatmentarm.ActivetreatmentarmpatientswillreceivestandardcareplussupplementationwithoralvitaminK2isoform360mcg3 timesweeklyforatotal durationof18months. Primaryoutcome measuredwill beabsolute differencein coronaryartery calcification scoreat18-monthbetweencontrolandinterventionarms.Secondaryoutcomeswillbetocompareabsolutedifferenceinaorticvalve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular over the same period.