Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
NCT Number: NCT06578520
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Heart Failure
Interventions: DRUG: Dapagliflozin
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-12-31
Locations: Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain

Summary:
Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.

Primary Outcome Measures: Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 3rd (8th week) visit control compared with the 6th (20th week)visit control., To explore the effect of iSGLT2 in natriuresis and the peritoneal elimination of sodium in patients with CKD and refractory HF treated with peritoneal dialysis., Through study completion, an average of 4 months
Secondary Outcome Measures: Mean difference of the sum between the volume of diuresis in 24 hours and the daily peritoneal effluent ultrafiltration rate (ml/24hours) in the 3rd (8th week) visit control compared with the 6th (20th week) visit control., To explore the effect of the use of iSGLT2 in diuresis and, in the peritoneal net ultrafiltration in patients with CKD and refractory HF treated with peritoneal dialysis., Through study completion, an average of 4 months|Mean difference of the sum between the volume of diuresis in 24 hours and the daily peritoneal effluent ultrafiltration rate (ml/24hours) in the 2nd (4th week) visit control compared with the 5th (16th week) visit control., To explore the effect of the use of iSGLT2 in diuresis and, in the peritoneal net ultrafiltration in patients with CKD and refractory HF treated with peritoneal dialysis., Through study completion, an average of 4 months|Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 2nd visit control compared with the 5th visit control., To explore the effect of iSGLT2 in natriuresis and the peritoneal elimination of sodium in patients with CKD and refractory HF treated with peritoneal dialysis., Through study completion, an average of 4 months|Mean difference between the hydration percentage: Total Body Water%, Extracellular Water% , Intracellular Water%, Plasma Fluid, Interstitial Fluid by bioimpedance in the 3rd visit control compared with the 6th visit control., To explore the effect of the use of iSGLT2 in the normalization of extracellular volume in patients with CKD and refractory HF treated with peritoneal dialysis., Through study completion, an average of 4 months|Collection of chemistry parameters: Mean change and standard deviations in Peritoneal Fluid Glucose Ratio and Sodium concentration in the effluent peritoneal dialysis fluid sample in the 3rd visit control compared with the 6th visit control., To evaluate the effect of the use of iSGLT2 in Glucose and sodium homeostasis in the peritoneal fluid effluent in patients with CKD and refractory HF treated with peritoneal dialysis., Through study completion, an average of 4 months|Mean change and standard deviations in Peritoneal Fluid Glucose Ratio (D4/D0) and Sodium (mEq/24hr) concentration in the effluent peritoneal dialysis fluid sample in the 2nd visit control compared with the 5th visit control., To evaluate the effect of the use of iSGLT2 in Glucose and sodium homeostasis in the peritoneal fluid effluent in patients with CKD and refractory HF treated with peritoneal dialysis., Through study completion, an average of 4 months|Mean Difference in NYHA Classification, Ultrasounds parameters for the evaluation of venous congestion and BNP (ng/ml), CA 125 (ng/ml) in the blood sample in the 3rd visit control compared with the 6th visit control., To evaluate the effect of the use of iSGLT2 in the clinical and laboratory parameters in patients with CKD and refractory HF treated with peritoneal dialysis., Through study completion, an average of 4 months|Mean difference in Ca125 (U/min), IL-6 (pg/min), in the effluent peritoneal dialysis fluid sample in the 3rd visit control compared with the 6th visit control., To study the effect of the use of iSGLT2 in the inflammatory state of the peritoneal membrane in patients with CKD and refractory HF treated with peritoneal dialysis., Through study completion, an average of 4 months|Mean Change in the total amount of loop diuretic and thiazide treatment (mg/daily) in the 3rd visit control compared with the 6th visit control., To evaluate the effect of the use of iSGLT2 in dose reduction of diuretics and the need for diuretic therapy in patients with CKD and refractory HF treated with peritoneal dialysis., Through study completion, an average of 4 months
Other Outcome Measures: Collection of serious adverse events. The proportion of patients treated with DAPA presenting these adverse events, in comparison to the patients non-treated with DAPA, at the visit control 3rd, 6th and 8th., To explore the safety of iSGLT2 in patients with CKD and refractory HF treated with peritoneal dialysis, Through study completion, an average of 4 months