The Intertwined Challenge: A Prospective Assessment of Empagliflozin Safety in Hemodialysis-Dependent Patients with Heart Failure

Introduction The integration of sodium-glucose cotransporter 2 (SGLT2) inhibitors into foundational heart failure (HF) therapy has revolutionized cardiorenal care. Despite their proven efficacy across the spectrum of HF and chronic kidney disease (CKD), the safety and tolerability of these agents in patients with end-stage kidney disease (ESKD) on hemodialysis remain a critical knowledge gap. This is the first clinical trial of empagliflozin in this specific population, designed to evaluate its short-term safety. Method This single-center, single-group, pretest–posttest study aimed to assess the short-term safety of empagliflozin in a cohort of 16 adult patients with heart failure with reduced ejection fraction (HFrEF) undergoing maintenance hemodialysis. Over a six-week period, participants received empagliflozin 10 mg daily. Results We observed no significant changes in acid-base parameters, electrolytes, or other key biochemical markers, mitigating primary safety concerns regarding metabolic acidosis. Notably, empagliflozin therapy was associated with a significant increase in 24-hour urine volume (p=0.019), a corresponding decrease in ultrafiltration volume required during dialysis (p=0.034), and increased urinary creatinine excretion (p=0.045). Conclusion These findings suggest that empagliflozin may not only be safe but may also help preserve or augment residual kidney function and improve fluid homeostasis in this high-risk population. While preliminary due to the study's small sample size and single-arm design, these results provide a crucial safety signal, supporting the feasibility of future large-scale, randomized controlled trials to establish the definitive role of SGLT2 inhibitors in dialysis-dependent patients. Trial registration : Clinicaltrial.gov, NCT05967156 (2023-07-15)