[Translation] An international, randomized, double-blind, placebo-controlled study evaluating the effects of sodium zirconium cyclosilicate on arrhythmia-related cardiovascular outcomes in subjects undergoing chronic hemodialysis with recurrent hyperkalemia (DIALIZE-Outcomes)
1)主要目的:评价环硅酸锆钠(SZC)与安慰剂相比在降低主要复合终点SCD、所有卒中或因心律失常而住院治疗/接受干预/急诊科(ED)就诊的发生率方面的有效性 2) 次要目的: a. 评价1 年时SZC与安慰剂相比在维持正常血钾水平方面的有效性 b. 评估SZC与安慰剂相比在降低因心律失常而住院治疗/接受干预/ED 就诊的发生率方面的有效性 c. 评估SZC与安慰剂相比在减少因心律失常而住院治疗/接受干预/ED 就诊方面的有效性 d. 评价SZC与安慰剂相比在减少高钾血症急救治疗需求方面的有效性 e. 评价1年时SZC与安慰剂相比在预防重度高钾血症方面的有效性 f. 评价SZC与安慰剂相比在降低SCD发生率方面的有效性 g. 评价SZC与安慰剂相比在降低所有卒中发生率方面的有效性 h. 评价SZC与安慰剂相比在降低CV死亡发生率方面的有效性 i. 评价SZC与安慰剂相比在降低全因性死亡发生率方面的有效性
3) 安全性目的: a. 在接受血液透析的受试者中评估SZC相较于安慰剂的安全性和耐受性
[Translation] 1) Primary Objective: To evaluate the effectiveness of sodium zirconium cyclosilicate (SZC) compared with placebo in reducing the incidence of the primary composite endpoint of SCD, all strokes, or hospitalizations/interventions/emergency department (ED) visits for arrhythmias 2) Secondary Objectives: a. To evaluate the effectiveness of SZC compared with placebo in maintaining normal blood potassium levels at 1 year b. To evaluate the effectiveness of SZC compared with placebo in reducing the incidence of hospitalizations/interventions/ED visits for arrhythmias c. To evaluate the effectiveness of SZC compared with placebo in reducing hospitalizations/interventions/ED visits for arrhythmias d. To evaluate the effectiveness of SZC compared with placebo in reducing the need for emergency treatment for hyperkalemia e. To evaluate the effectiveness of SZC compared with placebo in preventing severe hyperkalemia at 1 year f. To evaluate the effectiveness of SZC compared with placebo in reducing the incidence of SCD g. To evaluate the effectiveness of SZC compared with placebo in reducing the incidence of all strokes h. To evaluate the effectiveness of SZC in reducing the incidence of CV death compared with placebo i. To evaluate the effectiveness of SZC in reducing the incidence of all-cause death compared with placebo
3) Safety objectives: a. To evaluate the safety and tolerability of SZC compared with placebo in subjects undergoing hemodialysis