TY - JOUR
T1 - Cardiac arrhythmia and hypoglycaemia in patients receiving haemodialysis with and without diabetes (the CADDY study)
T2 - protocol for a Danish multicentre cohort study
AU - Kofod, Dea Haagensen
AU - Diederichsen, Søren Zöga
AU - Bomholt, Tobias
AU - Ørbæk Andersen, Mads
AU - Rix, Marianne
AU - Liem, Ylian
AU - Lindhard, Kristine
AU - Post Hansen, Henrik
AU - Rydahl, Casper
AU - Lindhardt, Morten
AU - Schandorff, Kristine
AU - Lange, Theis
AU - Nørgaard, Kirsten
AU - Almdal, Thomas P.
AU - Svendsen, Jesper Hastrup
AU - Feldt-Rasmussen, Bo
AU - Hornum, Mads
N1 - © 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.
PY - 2023/10/27
Y1 - 2023/10/27
N2 - 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.TRIAL REGISTRATION NUMBER: NCT04841304.
AB - 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.TRIAL REGISTRATION NUMBER: NCT04841304.
KW - Humans
KW - Renal Dialysis/adverse effects
KW - Blood Glucose Self-Monitoring
KW - Cohort Studies
KW - Prospective Studies
KW - Blood Glucose/analysis
KW - Arrhythmias, Cardiac/etiology
KW - Hypoglycemia/etiology
KW - Diabetes Mellitus/epidemiology
KW - Denmark/epidemiology
KW - Multicenter Studies as Topic
U2 - 10.1136/bmjopen-2023-077063
DO - 10.1136/bmjopen-2023-077063
M3 - Protocol
C2 - 37890966
SN - 2044-6055
VL - 13
SP - e077063
JO - BMJ open
JF - BMJ open
IS - 10
ER -