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Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study

RecruitingPhase 2Ages 18 Years - 70 YearsAllMaximo Agustin Schiavone
NCT06929169 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • iSGLT2
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Where

1 site
Fresenius Medical Care - CEMIC Saavedra
Buenos Aires, Argentina
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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