jDAPA-PD (jDAPA-PD)

Recruiting

• Conditions: Chronic heart failure, chronic kidney disease

• Registration Number: jRCT1031230624

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-08
• Study Start: 2024-06-17
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Change in extracellular water from baseline to week 24

Secondary Outcome Measures

Name	Time	Method
First cardiovascular event		death due to cardiovascular disease, myocardial infarction, unstable angina, stroke and transient ischemic attack, pulmonary thromboembolism, and acute leg ischemia
First event of hospitalization		excluding hospitalization for social reasons
Change in PD regimen	from baseline to week 24	up, down, no change
Weekly fluid removal	from baseline to week 24	urine, PD, total
Change in body composition indices	from baseline to week 24	body weight, BMI, ECW, ECW/height, ECW/body water
Change in echocardiographic parameters	from baseline to week 24	LVDd, LVDs, LVEF, LVMI, LAD, E/A