Division of Kidney Diseases and Hypertension, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA
Department of Nephrology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
BMJ Open. 2023 May 25;13(5):e071309. doi: 10.1136/bmjopen-2022-071309.
Patients with kidney failure receiving chronic haemodialysis have elevated risk of arrhythmias potentially increasing the likelihood of sudden cardiac death, stroke and hospitalisation. The DIALIZE study (NCT03303521) demonstrated that sodium zirconium cyclosilicate (SZC) was an efficacious and well-tolerated treatment for predialysis hyperkalaemia in patients undergoing haemodialysis. The DIALIZE-Outcomes study evaluates the effect of SZC on sudden cardiac death and arrhythmia-related cardiovascular outcomes in patients receiving chronic haemodialysis with recurrent hyperkalaemia.
International, multicentre, randomised, double-blind, placebo-controlled study conducted at 357 study sites across 25 countries. Adults (≥18 years) receiving chronic haemodialysis three times per week with recurrent predialysis serum potassium (K) ≥5.5 mmol/L post long interdialytic interval (LIDI) are eligible. Patients (~2800) will be randomised 1:1 to SZC or placebo, starting at 5 g orally once daily on non-dialysis days and titrated weekly in 5 g increments (maximum 15 g) to target predialysis serum K 4.0-5.0 mmol/L post LIDI. The primary objective is to evaluate efficacy of SZC versus placebo in reducing occurrence of the primary composite endpoint of sudden cardiac death, stroke or arrhythmia-related hospitalisation, intervention or emergency department visit. Secondary endpoints include efficacy of SZC versus placebo in maintaining normokalaemia (serum K 4.0-5.5 mmol/L post LIDI) at the 12-month visit, preventing severe hyperkalaemia (serum K ≥6.5 mmol/L post LIDI) at the 12-month visit and reducing the incidence of individual cardiovascular outcomes. Safety of SZC will be evaluated. The study is event driven, with participants remaining in the study until 770 primary endpoint events have occurred. Average time in the study is expected to be ~25 months.
Approval was obtained from the relevant institutional review board/independent ethics committee from each participating site (approving bodies in supplementary information). The results will be submitted to a peer-reviewed journal.
EudraCT 2020-005561-14 and clinicaltrials.gov identifier NCT04847232.
接受慢性血液透析的肾衰竭患者心律失常风险增加，这可能会增加心源性猝死、中风和住院的可能性。DIALIZE 研究（NCT03303521）表明，硅酸锆酸钠（SZC）可有效且耐受良好地治疗接受血液透析的高钾血症患者的透析前高钾血症。DIALIZE-Outcomes 研究评估了 SZC 对接受慢性血液透析且反复发生高钾血症的患者的心脏性猝死和心律失常相关心血管结局的影响。
这是一项在 25 个国家的 357 个研究地点进行的国际、多中心、随机、双盲、安慰剂对照研究。符合条件的患者为每周接受三次慢性血液透析，且长间透析间隔（LIDI）后透析前血清钾（K）≥5.5mmol/L 且反复出现的成年人（≥18 岁）。患者（约 2800 人）将按 1:1 随机分为 SZC 或安慰剂组，在非透析日开始每天口服 5g，每周递增 5g（最大 15g），使 LIDI 后透析前血清 K 目标值达到 4.0-5.0mmol/L。主要目标是评估 SZC 与安慰剂相比在降低主要复合终点（心源性猝死、中风或心律失常相关的住院、干预或急诊就诊）的发生率方面的疗效。次要终点包括 SZC 与安慰剂相比在 12 个月时维持正常血钾（LIDI 后血清 K 4.0-5.5mmol/L）的疗效、预防 12 个月时严重高钾血症（LIDI 后血清 K≥6.5mmol/L）的疗效以及降低个别心血管结局的发生率。将评估 SZC 的安全性。该研究是事件驱动的，参与者将在研究中一直保留，直到发生 770 例主要终点事件。预计平均研究时间约为 25 个月。
已从每个参与地点的相关机构审查委员会/独立伦理委员会获得批准（在补充信息中列出批准机构）。研究结果将提交给同行评议的期刊。
EudraCT 2020-005561-14 和 clinicaltrials.gov 标识符 NCT04847232。
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