NCT06929169 Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
| NCT ID | NCT06929169 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Maximo Agustin Schiavone |
| Condition | Chronic Kidney Disease Requiring Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-05 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-05 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with end-stage kidney disease (ESKD) on hemodialysis face an unacceptably high rate of cardiovascular complications, including heart failure, arrhythmias, and sudden cardiac death. Many of these outcomes are driven by diastolic dysfunction and cardiac fibrosis-conditions that are not adequately addressed by current therapies. SGLT2 inhibitors, originally developed for the treatment of type 2 diabetes, have demonstrated cardiovascular and renal protective effects across multiple patient populations, independent of glycemic control. This Phase 2, randomized, controlled clinical trial will evaluate the safety and efficacy of SGLT2 inhibitors in patients undergoing maintenance hemodialysis. A total of 80 participants will be randomized to receive either an SGLT2 inhibitor or standard care for 12 months. The primary objective is to determine whether SGLT2 inhibitors improve cardiac function, reduce myocardial fibrosis, and decrease the incidence of intradialytic hypotension. Secondary endpoints include cardiovascular events, hospitalization, and all-cause mortality. The study will also assess changes in key biomarkers and perform advanced cardiac imaging to evaluate structural and functional outcomes. This trial represents a novel and timely investigation into a class of medications with promising pleiotropic effects, potentially offering new therapeutic options for a high-risk, underserved population.
Eligibility 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
Contact & Investigator
Carlos E Castellaro, MD, MSc
STUDY DIRECTOR
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Frequently Asked Questions
Who can join the NCT06929169 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Chronic Kidney Disease Requiring Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06929169 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06929169 currently recruiting?
Yes, NCT06929169 is actively recruiting participants. Contact the research team at maximoschiavone@gmail.com for enrollment information.
Where is the NCT06929169 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina.
Who is sponsoring the NCT06929169 clinical trial?
NCT06929169 is sponsored by Maximo Agustin Schiavone. The principal investigator is Carlos E Castellaro, MD, MSc at Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno. The trial plans to enroll 80 participants.
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