Vitamin K for kidney transplant organ recipients: investigating vEssel stiffness (ViKTORIES): study rationale and protocol of a randomised controlled trial

Lees, J. S. , Mangion, K., Rutherford, E., Witham, M. D., Woodward, R., Roditi, G., Hopkins, T., Brooksbank, K., Jardine, A. and Mark, P. B. (2020) Vitamin K for kidney transplant organ recipients: investigating vEssel stiffness (ViKTORIES): study rationale and protocol of a randomised controlled trial. Open Heart, 7, e001070. (doi: 10.1136/openhrt-2019-001070) (PMID:32675297) (PMCID:PMC7368482)

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Abstract

Background: Renal transplant recipients (RTRs) exhibit increased vascular stiffness and calcification; these parameters are associated with increased cardiovascular risk. Activity of endogenous calcification inhibitors such as matrix gla protein (MGP) is dependent on vitamin K. RTRs commonly have subclinical vitamin K deficiency. The Vitamin K in kidney Transplant Organ Recipients: Investigating vEssel Stiffness (ViKTORIES) study assesses whether vitamin K supplementation reduces vascular stiffness and calcification in a diverse population of RTR. Methods and analysis: ViKTORIES (ISRCTN22012044) is a single-centre, phase II, parallel-group, randomised, double-blind, placebo-controlled trial of the effect of vitamin K supplementation in 90 prevalent RTR. Participants are eligible if they have a functioning renal transplant for >1 year. Those on warfarin, with atrial fibrillation, estimated glomerular filtration rate <15 mL/min/1.73 m2 or contraindications to MRI are excluded. Treatment is with vitamin K (menadiol diphosphate) 5 mg three times per week for 1 year or matching placebo. All participants have primary and secondary endpoint measures at 0 and 12 months. The primary endpoint is ascending aortic distensibility on cardiac MR imaging. Secondary endpoints include vascular calcification (coronary artery calcium score by CT), cardiac structure and function on MR, carotid-femoral pulse wave velocity, serum uncarboxylated MGP, transplant function, proteinuria and quality of life. The study is powered to detect 1.0×10–3 mm Hg-1 improvement in ascending aortic distensibility in the vitamin K group relative to placebo at 12 months. Analyses will be conducted as between-group differences at 12 months by intention to treat. Discussion: This trial may identify a novel, inexpensive and low-risk treatment to improve surrogate markers of cardiovascular risk in RTR.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Mark, Dr Patrick and Rutherford, Dr Elaine and Mangion, Dr Kenneth and Brooksbank, Dr Katriona and Hopkins, Mrs Tracey and Lees, Jennifer and Roditi, Dr Giles and Jardine, Professor Alan
Authors: Lees, J. S., Mangion, K., Rutherford, E., Witham, M. D., Woodward, R., Roditi, G., Hopkins, T., Brooksbank, K., Jardine, A., and Mark, P. B.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:Open Heart
Publisher:BMJ Publishing Group
ISSN:2053-3624
ISSN (Online):2053-3624
Published Online:15 July 2020
Copyright Holders:Copyright © 2020 The Authors
First Published:First published in Open Heart 7:e001070
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
190814BHF centre of excellenceRhian TouyzBritish Heart Foundation (BHF)RE/13/5/30177Institute of Cardiovascular & Medical Sciences