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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Self Control

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

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

oral Dapagliflozin tablets 10mg/day for 6 months

Interventions

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Dapagliflozin

oral Dapagliflozin tablets 10mg/day for 6 months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No