Effects of SGLT2 inhibitors on heart health in hemodialysis patients
Official title: Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
Run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno · NCT06929169 · Data updated 2026-11-12
This study is testing if a new type of diabetes medication can improve heart health in patients with kidney failure who are on hemodialysis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno Academic / other |
| Locations | 1 site (Buenos Aires, Buenos Aires) |
| Status | Recruiting |
| Started | May 2025 |
| Main results expected | July 2026 |
| Study ends | August 2026 |
| Registry record updated | April 16, 2025 |
| Trial ID | NCT06929169 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-70 with end-stage renal disease who have been on hemodialysis for at least three months.
✕Probably not a fit
Patients currently on immunosuppressive therapy or with contraindications to cardiac MRI may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 randomized controlled trial investigates the safety and efficacy of SGLT2 inhibitors in patients with end-stage renal disease undergoing hemodialysis. A total of 80 participants will be enrolled and randomly assigned to receive either an SGLT2 inhibitor or standard care for 12 months. The study aims to evaluate improvements in cardiac function, reductions in myocardial fibrosis, and the incidence of intradialytic hypotension. Key assessments will include cardiac MRI and biomarker analysis to measure changes in heart health.
Why it matters
Potential benefit: If successful, this study could lead to improved heart health and reduced cardiovascular complications for patients on hemodialysis.
How similar studies have gone: Other studies have shown promising results with SGLT2 inhibitors in different populations, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 and ≤70 years * Diagnosed with end-stage renal disease * Undergoing online hemodiafiltration for at least 3 months * Able to provide written informed consent Exclusion Criteria: * Current immunosuppressive therapy * Contraindication to cardiac MRI * Known hypersensitivity or intolerance to SGLT2 inhibitors * Participation in another interventional clinical trial * History of diabetic ketoacidosis * Active substance abuse * Diagnosis of type 1 diabetes mellitus * History of kidney transplantation * Acute coronary event within 30 days before enrollment * Current or recent treatment with an SGLT2 inhibitor
Where it's running
-
Fresenius Medical Care - CEMIC Saavedra
Buenos Aires, Buenos Aires, Argentina Recruiting
Study contacts
- Study coordinator: Maximo A Schiavone, MD, MSc
- Email: maximoschiavone@gmail.com
- Phone: +5491138093510
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.