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

T

The People's Hospital of Gaozhou

Status and phase

Enrolling
Phase 4

Conditions

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

Treatments

Drug: Dapagliflozin

Study type

Interventional

Funder types

Other

Identifiers

NCT06365541
GYLLPJ-2024006

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Self Control
Experimental group
Description:
Compare the heart function of dialysis patients before treatment and during the third and sixth months of treatment.
Treatment:
Drug: Dapagliflozin

Trial contacts and locations

1

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Central trial contact

Mingsheng Zhu

Data sourced from clinicaltrials.gov

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