Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578520
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
Sponsor:
None
Organization:
None
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:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None