Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Provision of informed consent form prior to any study specific procedures, sampling and analysis.
Individuals must be ≥ 18 years of age at the time of signing the informed consent
Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).
Limited life expectancy (less than 1 year) based on investigator's clinical judgement.
Patients without indication of beginning treatment with Dapagliflozin according to the Data Sheets and Consumer Medicine Information.
Malignancy (with active treatment) or other life-threatening disease
Patients in whom proper study compliance cannot be guaranteed
Crossover
Dapagliflozin
Drug10 mg once per day, oral tablets
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.
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.
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.
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.
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.
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
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