Phase 2 Study of SGLT2 Inhibitors to Improve Heart Health in Adults on Hemodialysis with End-Stage Kidney Disease

What this Trial Is About

This research aims to evaluate the safety and effectiveness of sodium-glucose cotransporter 2 inhibitors SGLT2i in patients with end-stage kidney disease undergoing maintenance hemodialysis. Cardiovascular complications such as heart failure, arrhythmias, and sudden cardiac death are common in this group, often linked to diastolic dysfunction and cardiac fibrosis that current treatments do not adequately address. This Phase 2 randomized controlled trial seeks to determine if SGLT2 inhibitors can improve cardiac function and reduce these risks. Participants will be randomly assigned to one of two groups one receiving standard hemodialysis care without SGLT2 inhibitors, and the other receiving a once-daily oral SGLT2 inhibitor alongside standard care for 12 months. The intervention group will be monitored through advanced cardiac imaging and biomarker assessments at baseline and at 3, 6, and 12 months. The study will assess changes in heart structure and function, myocardial fibrosis, and the frequency of intradialytic hypotension. Throughout the 12-month study, participants will undergo comprehensive evaluations including echocardiography, cardiac MRI, 24-hour heart rhythm monitoring, and laboratory tests. Researchers will track cardiovascular events, hospitalizations, and mortality. Data will be collected at multiple time points to measure outcomes such as changes in left ventricular mass and ejection fraction, fibrosis biomarkers, and incidence of hypotension during dialysis. This thorough monitoring aims to provide new insights into cardiac health in dialysis patients.

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