Effects of SGLT2 inhibitors on heart health in hemodialysis patients
Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno Academic / other |
| Locations | 1 site (Buenos Aires, Buenos Aires) |
| Trial ID | NCT06929169 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with end-stage renal disease who have been on hemodialysis for at least three months.
Not a fit: Patients currently on immunosuppressive therapy or with contraindications to cardiac MRI may not benefit from this study.
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 performed: Other studies have shown promising results with SGLT2 inhibitors in different populations, suggesting potential for success in this novel application.
Eligibility criteria
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 this trial is running
Buenos Aires, Buenos Aires
- 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
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.