The Safety and Efficacy of Empagliflozin in End-stage Renal Disease Patients with Heart Failure with Reduced Ejection Fraction - A Randomized Controlled Trial

What this Trial Is About

Researchers are investigating the safety and effectiveness of empagliflozin in patients who have end-stage renal disease (ESRD) and heart failure with reduced ejection fraction (HFrEF). This trial addresses the challenge that while some drug classes improve survival in HFrEF, their benefits and safety in patients undergoing chronic hemodialysis are unclear. Although empagliflozin mainly targets kidney function, its potential heart benefits independent of kidney function are being explored, especially since patients with ESRD face higher cardiovascular risks. Participants in this study will be randomly assigned to receive either empagliflozin 25 mg or a placebo once daily for six months. The trial is designed as a single-blind, randomized controlled study to compare these treatments. The primary focus is to assess changes in left ventricular mass after 24 weeks of treatment, with multiple secondary measures including heart function, blood pressure, walking distance, and various laboratory tests taken over 12 and 24 weeks. During the study, participants will undergo regular evaluations including imaging tests to measure heart function, blood tests to monitor markers like NT-proBNP and HbA1c, and physical assessments such as a 6-minute walk test. Researchers will also track safety outcomes including infections and adverse events. The entire treatment period lasts six months, with detailed follow-up assessments to evaluate cardiovascular health and treatment effects.

Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Disease