Department of Nephrology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark
Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
BMJ Open. 2023 Oct 27;13(10):e077063. doi: 10.1136/bmjopen-2023-077063.
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.
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.
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.
NCT04841304.
接受血液透析的患者心律失常和心源性猝死的风险增加，但心律失常负担和病理生理学的数据仍然有限。在潜在的危险因素中，低血糖被认为是致命性心律失常的可能触发因素。植入式环路记录器 (ILR) 和连续血糖监测 (CGM) 的发展使长期连续心电图和血糖监测成为可能。本文介绍了一项旨在增加对接受血液透析患者心律失常和危险因素的理解的研究方案。研究结果将详细探讨这些患者心律失常的负担和性质，包括低血糖与心律失常之间的潜在关联。
该研究是一项由研究者发起的、前瞻性的、多中心队列研究，招募了 70 名接受血液透析的患者：35 名患有糖尿病，35 名没有糖尿病。参与者接受 ILR 和 CGM 监测 18 个月的随访。数据收集进一步包括每月采集透析前血液样本和透析参数。主要结局是存在临床上显著的心律失常，定义为心动过缓、室性心动过速或室颤的综合表现。次要结局包括临床显著心律失常和其他心律失常的特征、血糖特征和死亡率。数据分析包括评估心律失常与低血糖和高血糖、基线临床变量以及与肾衰竭和血液透析过程相关的参数之间的关联。
该研究已获得丹麦首都大区伦理委员会的批准 (H-20069767)。研究结果将在国家和国际大会以及国际同行评议的科学期刊上公布。
NCT04841304。
