The effects of empagliflozin on ultrafiltration in patients with peritoneal dialysis
- Conditions
- Patients with chronic heart failure on peritoneal dialysis (PD)
- Registration Number
- JPRN-jRCTs051230081
- Lead Sponsor
- Doi Yohei
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 36
(1) Age >=18 and <=90 years
(2) BNP >= 40pg/mL, NT-proBNP >= 400 pg/mL, structural heart disease (left atrial enlargement and/or left ventricular hypertrophy), elevated filling pressures, or a history of hospitalization for heart failure
(3) Standard medical therapy for heart failure (at least one of the following: loop diuretics, ACEIs, ARBs, ARNIs, beta-blockers, MRAs)
(4) PD vintage >= 3 months
(5) Patients using more than 3 liters of dextrose peritoneal dialysis solution per day
(6) Patients who voluntarily provide consent for participation in this study
(1) Treatment with SGLT2 inhibitors within 3 months prior to enrollment
(2) Patients who are not expected to survive more than 1 year after enrollment
(3) On a hybrid therapy of peritoneal dialysis and hemodialysis
(4) Current peritonitis or a history of peritonitis within the past 2 months
(5) Pregnant or breast-feeding
(6) Active infections
(7) Current participation in clinical trials with intervention
(8) Patients who are judged by the Investigator to be inappropriate for the study for reasons not specified elsewhere
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in ultrafiltration volume with dextrose peritoneal dialysis solution after 8 weeks of the treatment period (ultrafiltration volume is the average of 5 days excluding the maximum and minimum days out of 7 consecutive days)
- Secondary Outcome Measures
Name Time Method (1) Changes in NT-proBNP and BNP<br>(2) Changes in FAST PET-related factors: ultrafiltration volume, sodium, potassium, glucose, urea nitrogen, creatinine, uric acid,protein,IL-6, CA-125, dialysate to serum creatinine ratio<br>(3) Changes in 24-hour urine-related factors: urine volume, sodium, potassium, glucose, urea nitrogen, creatinine, uric acid, urine protein,urea clearance, creatinine clearance (mean of urea and creatinine clearance)<br>(4) urinary kidney injury molecule-1<br>(5) Changes in anemia-related factors: hemoglobin, hematocrit, ferritin, transferrin saturation<br>(6) Changes in body weight and blood pressure<br>(7) Changes in body composition: intracellular fluid volume, extracellular fluid volume, fluid overload<br>(8) Adverse events