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
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