Cardiac arrhythmia and hypoglycaemia in patients receiving haemodialysis with and without diabetes (the CADDY study): Protocol for a Danish multicentre cohort study

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Introduction Patients receiving haemodialysis are at increased risk of arrhythmias and sudden cardiac death, but data on arrhythmia burden and the pathophysiology remain limited. Among potential risk factors, hypoglycaemia is proposed as a possible trigger of lethal arrhythmias. The development of implantable loop recorders (ILR) and continuous glucose monitoring (CGM) enables long-term continuous ECG and glycaemic monitoring. The current article presents the protocol of a study aiming to increase the understanding of arrhythmias and risk factors in patients receiving haemodialysis. The findings will provide a detailed exploration of the burden and nature of arrhythmias in these patients including the potential association between hypoglycaemia and arrhythmias.

Methods and analysis The study is an investigator-initiated, prospective, multicentre cohort study recruiting 70 patients receiving haemodialysis: 35 with diabetes and 35 without diabetes. Participants are monitored with ILRs and CGM for 18 months follow-up. Data collection further includes a monthly collection of predialysis blood samples and dialysis parameters. The primary outcome is the presence of clinically significant arrhythmias defined as a composite of bradycardia, ventricular tachycardia, or ventricular fibrillation. Secondary outcomes include the characterisation of clinically significant arrhythmias and other arrhythmias, glycaemic characteristics, and mortality. The data analyses include an assessment of the association between arrhythmias and hypoglycaemia and hyperglycaemia, baseline clinical variables, and parameters related to kidney failure and the haemodialysis procedure.

Ethics and dissemination The study has been approved by the Ethics Committee of the Capital Region of Denmark (H-20069767). The findings will be presented at national and international congresses as well as in international peer-reviewed scientific journals.
OriginalsprogEngelsk
Artikelnummere077063
TidsskriftBMJ Open
Vol/bind13
Udgave nummer10
Antal sider7
ISSN2044-6055
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
DHK has received speaker honoraria from Bayer A/S outside the submitted work. SZD is a consultant to Cortrium and Vital Beats and a member of Bristol Myers Squibb/Pfizer advisory board and has received speaker honoraria from Bristol Myers Squibb/Pfizer and Bayer. TB is a member of Medtronic and AstraZeneca advisory board and has received speaker honoraria from AstraZeneca outside the submitted work. ML is a member of advisory board at AstraZeneca, Bayer A/S Denmark, Boehringer Ingelheim, GlaxoSmithKline and received speaker honoraria from AstraZeneca, Bayer A/S Denmark and Boehringer Ingelheim. KN holds stocks in Novo Nordisk; has been a paid consultant for Novo Nordisk and Medtronic; has received speaker honorarium and honorarium for Advisory Board to her institution from Medtronic, Novo Nordisk, Convatec, and her institution has received research funding from Zealand Pharma, Novo Nordisk, Medtronic and Dexcom. TPA holds stocks in Novo Nordisk A/S. JHS is a member of Medtronic advisory board and has received speaker honoraria and research grants from Medtronic outside the submitted work. MH has served on scientific advisory boards for the following companies outside the scope of this study: Astra Zeneca A/S, Boehringer Ingelheim A/S, GSK A/S and CSL Vifor Pharma A/S; has served as moderator of a symposium and an educational meeting for Astra Zeneca A/S; has received research grants from the A.P. Møller Foundation, Augustinus Foundation, Helen Bjørnow Foundation, Lundbeck Foundation and has a Twinning Horizon Europe Grant. All other authors have no conflicts of interest to declare.

Funding Information:
This study is supported by grants from the Rigshospitalet’s research foundation, the Augustinus Foundation (grant number 20-1977), Skibsreder Per Henriksen R og Hustrus Fond (grant number 01-10403), Johnny Weilebys Fond (grant number 10-100067), Helen og Ejnar Bjørnows Fond and Region Zealand's Health Research Foundation. CGM equipment was partly sponsored by Dexcom, and ILRs were partly sponsored by Medtronic. The funders had no role in the study.

Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

ID: 376250971