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

NCT06365541 | Recruiting Phase 4

• 1 other identifier: GYLLPJ-2024006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• N-terminal B-type natriuretic peptide precursor (NT-proBNP)

  Changes in NT-proBNP levels before and after treatment

  Baseline, 3 months, 6 months

• Left ventricular ejection fraction (LVEF)

  Changes in LVEF levels before and after treatment

  Baseline, 3 months, 6 months

Study Arms (1)

Self Control

EXPERIMENTAL

Compare the heart function of dialysis patients before treatment and during the third and sixth months of treatment.

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

oral Dapagliflozin tablets 10mg/day for 6 months

Self Control

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The People's Hospital of Gaozhou: lead

Study Sites (1)

The People's Hospital of Gaozhou

Maoming, Guangdong, 525200, China

RECRUITING

MeSH Terms

Interventions

dapagliflozin

Central Study Contacts

Mingsheng Zhu

CONTACT

15016656405; ms160@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Exploring the efficacy and safety of dapagliflozin in improving heart failure in dialysis patients by the analysis and comparison of patients' own data before and after dapagliflozin treatment

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: March 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)