The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients
Conditions
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.
Interventions
DRUGDapagliflozin
oral Dapagliflozin tablets 10mg/day for 6 months
Sponsors
The People's Hospital of Gaozhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactMingsheng Zhu
Outcome results
None listed