Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT06578520
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2024-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Organization:
Study Overview
Official Title:
Effect of the Use of Dapagliflozin in Diuresis, Natriuresis and in Ultrafiltration and Peritoneal Elimination of Sodium, in Patients With Refractory Heart Failure
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.
Detailed Description:
Peritoneal dialysis (PD) is a technique that has been successfully used for the treatment of refractory heart failure to diuretics. In patients on PD, the harmful effects of sodium retention become even greater, resulting in fluid overload, hypertension and left ventricular hypertrophy in more than half of the PD population. This is due to the fact that the accumulation of sodium in the skin interstitium would generate an inflammatory environment and, therefore, the activation of growth and fibrogenic factors with a consequent increase in cardiac muscle mass.
In patients with HF receiving PD, therefore, it is necessary to reduce salt intake with diet, as well as to ensure adequate elimination through available medical treatments and elimination of Na through the most appropriate dialysis technique.
In recent years, a new player has joined the treatment of HF: iSGLT2, an oral hypoglycaemic drug. ISGLT2 promotes natriuresis thanks to its well-known mechanism of inhibition of Na and glucose co-transporter. Also promoting excretion of Na at the distal tubule level due to increased tubular osmotic pressure secondary to glycosuria, as well as by direct inhibition of NH3 channels reabsorbing Na and Hydrogens.
The purpose of the study is to analyse whether the use of an SGLT2 inhibitor (Dapagliflozin) in patients with CKD and HF treated with peritoneal dialysis can benefit patients in terms of increased total elimination of sodium and water.
In this study, dapagliflozin will be used together with established drug therapy for patients with HF, including concomitant diuretic therapy.
after randomization, the patient will be divided in two groups and they will receive the study drug or placebo for 8 weeks and, after a 4-week wash out, each patient will switch groups for further 8 weeks to receive standard of care or standard of care plus Dapaglifozin as appropriate.
The study will end with a safety extension study in which all patients will take Dapagliflozin for a further 8 weeks.
In patients with HF receiving PD, therefore, it is necessary to reduce salt intake with diet, as well as to ensure adequate elimination through available medical treatments and elimination of Na through the most appropriate dialysis technique.
In recent years, a new player has joined the treatment of HF: iSGLT2, an oral hypoglycaemic drug. ISGLT2 promotes natriuresis thanks to its well-known mechanism of inhibition of Na and glucose co-transporter. Also promoting excretion of Na at the distal tubule level due to increased tubular osmotic pressure secondary to glycosuria, as well as by direct inhibition of NH3 channels reabsorbing Na and Hydrogens.
The purpose of the study is to analyse whether the use of an SGLT2 inhibitor (Dapagliflozin) in patients with CKD and HF treated with peritoneal dialysis can benefit patients in terms of increased total elimination of sodium and water.
In this study, dapagliflozin will be used together with established drug therapy for patients with HF, including concomitant diuretic therapy.
after randomization, the patient will be divided in two groups and they will receive the study drug or placebo for 8 weeks and, after a 4-week wash out, each patient will switch groups for further 8 weeks to receive standard of care or standard of care plus Dapaglifozin as appropriate.
The study will end with a safety extension study in which all patients will take Dapagliflozin for a further 8 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: