Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
BMJ Open. 2024 Aug 27;14(8):e087617. doi: 10.1136/bmjopen-2024-087617.
Heart failure with preserved ejection fraction (HFpEF) is a prevalent comorbidity among patients with end-stage kidney disease. Although sodium-glucose cotransporter 2 inhibitors are validated in treating heart failure and ameliorating left ventricular hypertrophy among non-dialysis patients, the effects on dialysis patients are unknown. We previously investigated the pharmacokinetics of henagliflozin in patients undergoing haemodialysis (HD) or peritoneal dialysis (PD) and clarified its safety.
This multicentre, randomised, double-blind, placebo-controlled trial is being conducted at three hospitals in Shanghai, China. A target of 108 HD or PD patients with HFpEF are randomly allocated to treatment group (henagliflozin 5 mg/day in addition to standard therapy) or control group (placebo with standard therapy) at a ratio of 1:1. All subjects will be followed up for 24 weeks. The primary outcome is change in echocardiography-measured left ventricular mass index. The secondary interests include changes in left atrial volume index, E/e', e' and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Intergroup comparisons of change in echocardiography-related outcomes from baseline to 24 weeks are based on a linear regression model adjusted for baseline values (analysis of covariance), and repeated measure analysis of variance with Bonferroni adjustment is employed for comparison of change in NT-proBNP. Subgroup analyses of the primary and secondary outcomes are conducted to determine whether the effect of henagliflozin varies according to dialysis modality. The χ method is used to compare the occurrence of adverse events and severe adverse events.
This trial has been approved by the Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiao Tong University (LY2023-127-B). All participants provide written informed consent before screening. The results of the trial will be disclosed completely in international peer-reviewed journals. Both positive and negative results will be reported.
ChiCTR2300073169.
射血分数保留的心力衰竭（HFpEF）是终末期肾病患者常见的合并症。尽管钠-葡萄糖共转运蛋白 2 抑制剂已被证实可用于治疗心力衰竭并改善非透析患者的左心室肥厚，但对透析患者的影响尚不清楚。我们之前研究了亨格列净在接受血液透析（HD）或腹膜透析（PD）的患者中的药代动力学，并明确了其安全性。
这项多中心、随机、双盲、安慰剂对照试验正在中国上海的三家医院进行。将 108 名 HFpEF 的 HD 或 PD 患者按 1:1 的比例随机分为治疗组（在标准治疗的基础上加用亨格列净 5mg/天）或对照组（标准治疗加安慰剂）。所有患者将随访 24 周。主要结局是超声心动图测量的左心室质量指数的变化。次要兴趣包括左心房容积指数、E/e'、e'和 N 末端 pro-B 型利钠肽（NT-proBNP）的变化。基于协方差分析（分析协方差）调整基线值的线性回归模型，对 24 周时超声心动图相关结局从基线的变化进行组间比较，对 NT-proBNP 的变化进行重复测量方差分析，并用 Bonferroni 调整进行比较。对主要和次要结局进行亚组分析，以确定亨格列净的作用是否根据透析方式而有所不同。χ2 方法用于比较不良事件和严重不良事件的发生情况。
这项试验已获得上海交通大学医学院仁济医院伦理委员会的批准（LY2023-127-B）。所有参与者在筛选前均提供书面知情同意。试验结果将在国际同行评议期刊上完全公布。将报告阳性和阴性结果。
ChiCTR2300073169。
