- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06365541
The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients
April 9, 2024 updated by: deng shanshan, The People's Hospital of Gaozhou
Exploring the Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients: an Open, Prospective, and Self-controlled Study
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mingsheng Zhu
- Phone Number: 15016656405
- Email: ms160@163.com
Study Locations
-
-
Guangdong
-
Maoming, Guangdong, China, 525200
- Recruiting
- The People's Hospital of Gaozhou
-
Contact:
- Mingsheng Zhu
- Phone Number: 15016656405
- Email: ms160@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self Control
Compare the heart function of dialysis patients before treatment and during the third and sixth months of treatment.
|
oral Dapagliflozin tablets 10mg/day for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
N-terminal B-type natriuretic peptide precursor (NT-proBNP)
Time Frame: Baseline, 3 months, 6 months
|
Changes in NT-proBNP levels before and after treatment
|
Baseline, 3 months, 6 months
|
Left ventricular ejection fraction (LVEF)
Time Frame: Baseline, 3 months, 6 months
|
Changes in LVEF levels before and after treatment
|
Baseline, 3 months, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
August 31, 2024
Study Registration Dates
First Submitted
April 9, 2024
First Submitted That Met QC Criteria
April 9, 2024
First Posted (Estimated)
April 15, 2024
Study Record Updates
Last Update Posted (Estimated)
April 15, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GYLLPJ-2024006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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