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

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

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

Conditions2

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