The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients

Phase 4

Recruiting

• Conditions: The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients
• Interventions: Drug: Dapagliflozin

• Registration Number: NCT06365541
• Lead Sponsor: The People's Hospital of Gaozhou

Brief Summary

Dialysis patients have a higher incidence of cardiovascular events and require more effective measures to delay the progression of heart failure. Many studies have shown that dapagliflozin has cardioprotective effect, but most studies focus on non-dialysis patients with eGFR more than 20ml/min/1.73m2. However, the data on patients with eGFR less than 20ml/min/1.73m2 or dialysis patients, especially peritoneal dialysis patients, is less. Exploring the efficacy and safety of Dapagliflozin in improving heart failure in dialysis patients is of great clinical significance.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Age between 20 and 70 years old; 2.Maintenance dialysis for longer than 3 months; 3.Diagnosis with chronic heart failure, Left ventricular ejection fraction (LVEF)≤40% or NT-proBNP>12000pg/ml; 4.The patient signs an informed consent form.

Exclusion Criteria

• 1.Patients with liver function impairment; 2.Patients with severe hypoglycemia/hypotension/ketoacidosis; 3.Patients with active pyelonephritis or symptomatic urinary tract infection; 4.Dapagliflozin allergies or severe adverse reactions; 5.Patients suffering from other severe diseases; 6.Patients participating in other clinical trials; 7.Pregnant or lactating women; 8.Failure to sign a written informed consent form; 9.Unable or unwilling to comply with the experimental protocol approved by the researcher

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self Control	Dapagliflozin	Compare the heart function of dialysis patients before treatment and during the third and sixth months of treatment.

Primary Outcome Measures

Name	Time	Method
N-terminal B-type natriuretic peptide precursor (NT-proBNP)	Baseline, 3 months, 6 months	Changes in NT-proBNP levels before and after treatment
Left ventricular ejection fraction (LVEF)	Baseline, 3 months, 6 months	Changes in LVEF levels before and after treatment

Trial Locations

Locations (1)

The People's Hospital of Gaozhou; 🇨🇳 Maoming, Guangdong, China