跳至主要内容
临床试验/jRCT1031230624
jRCT1031230624招募中不适用

Dapagliflozin for peritoneal dialysis patients with chronic heart failure in Japan: a multicenter, open-label, randomized controlled trial (jDAPA-PD)

未提供0 个研究点目标入组 40 人开始时间: 2024年6月17日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit(—)
性别
All

入选标准

  • Patients who provide written consent based on their own free will to participate in this study.
  • Patients who are 18 years of age or older
  • Patients who are undergoing peritoneal dialysis for the treatment of end-stage kidney disease for more than 3 months
  • Patients whose peritoneal dialysis regimen is stable for at least 4 weeks
  • Patients who are diagnosed with chronic heart failure and receiving standard treatment

排除标准

  • Patients who are participating in other clinical studies
  • Patients who are pregnant or breast feeding
  • Patients who have received SGLT2 inhibitors within 4 weeks
  • Patients who have received hemodialysis within 4 weeks
  • Patients who are treated for peritonitis within 4 weeks
  • Patients with a daily urine volume of less than 500 mL
  • Patients who have difficulty with infusion and drainage of peritoneal dialysis dialysate
  • Patients who are considering discontinuation of peritoneal dialysis within 8 weeks after enrollment.
  • Patients who have difficulty performing bioelectrical impedance analysis tests (pacemakers, and limb defects)
  • Patients who are allergic to dapagliflozin
  • Patients who are considered inappropriate to participate by investigators

结局指标

主要结局

-

Change in extracellular water from baseline to week 24

次要结局

  • First cardiovascular event
  • First event of hospitalization
  • Change in body composition indices(from baseline to week 24)
  • Change in echocardiographic parameters(from baseline to week 24)
  • Change in PD regimen(from baseline to week 24)
  • Weekly fluid removal(from baseline to week 24)

研究者

发起方
未提供

相似试验