Effects of Dapagliflozin on Heart Function in Patients with End-stage Kidney Disease
Dapagliflozin Cardiovascular Effects on Patients at End-stage Renal Disease
This study is testing if dapagliflozin can help improve heart function and reduce heart problems in adults with end-stage kidney disease who are on dialysis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Campinas, Brazil Academic / other |
| Locations | 1 site (Campinas, SP) |
| Trial ID | NCT05685394 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of dapagliflozin, a sodium glucose co-transporter type 2 inhibitor, on myocardial function in patients with end-stage kidney disease (ESKD) who are undergoing dialysis. The study aims to determine whether dapagliflozin can reduce cardiovascular complications, which are a leading cause of death in this population. Eligible participants are adults over 18 years old who have been on dialysis for at least three months. The trial excludes individuals with certain health conditions, including recent myocardial infarction and known allergies to the study medication.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been on dialysis for at least three months.
Not a fit: Patients who are pregnant, have hepatic failure, or have had a recent myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and reduce cardiovascular risks for patients with end-stage kidney disease.
How similar studies have performed: Previous studies have shown that SGLT2 inhibitors can reduce cardiovascular events in patients with chronic kidney disease, suggesting potential success for this approach in ESKD.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * On regular dialysis regimen for at least 3 months Exclusion Criteria: * Known allergy to any of the investigational drug components * Current use of sodium-glucose co-transporter 2 inhibitors * Pregnant woman * Myocardial infarction or myocardial revascularization in the past 3 months
Where this trial is running
Campinas, SP
- Centro de Pesquisas Clínicas — Campinas, Sp, Brazil (Recruiting)
Study contacts
- Study coordinator: Joaquim Barreto, MD
- Email: joaquimbarretoantunes@gmail.com
- Phone: +55 19 3521 7959
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.