Using Dapagliflozin to Improve Heart Failure in Dialysis Patients
Exploring the Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients: an Open, Prospective, and Self-controlled Study
This study is testing if the medication dapagliflozin can help people with chronic heart failure who are on dialysis feel better and improve their heart health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | The People's Hospital of Gaozhou Academic / other |
| Locations | 1 site (Maoming, Guangdong) |
| Trial ID | NCT06365541 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of dapagliflozin in patients undergoing dialysis who have chronic heart failure. It focuses on individuals with a left ventricular ejection fraction of 40% or less or elevated NT-proBNP levels. The study aims to provide insights into how dapagliflozin can help manage heart failure in this specific patient population, which has been underrepresented in previous research. Participants will be monitored for improvements in heart function and overall cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 to 70 who have been on maintenance dialysis for over three months and have chronic heart failure.
Not a fit: Patients with severe liver impairment, active infections, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for dialysis patients suffering from heart failure, potentially improving their quality of life and health outcomes.
How similar studies have performed: While dapagliflozin has shown cardioprotective effects in non-dialysis patients, this study is novel as it specifically targets dialysis patients with limited prior research in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Maoming, Guangdong
- The People's Hospital of Gaozhou — Maoming, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Mingsheng Zhu
- Email: ms160@163.com
- Phone: 15016656405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.