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Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 28, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT06249932). This is a study registration, not published results. Lead sponsor: National Taiwan University Hospital. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 95 participants (ESTIMATED). Conditions: Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis. Interventions: DRUG: Empagliflozin 25 MG; DRUG: Placebo. Primary outcome measures: Left ventricular mass , 24 weeks of treatment. Brief summary: In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality. Several drug classes that provide survival benefits for patients with HFrEF, including SGLT2i, lack data regarding their efficacy and safety in patients under chronic hemodialysis. As the primary target of SGLT2i is expressed mostly in the kidneys, the efficacy of SGLT2i in patients with ESRD may be limited. On the other hand, patients with ESRD are at higher risks of experiencing cardiovascular events and may still benefit from treatment. Several mechanistic studies have demonstrated direct actions of SGLT2i on the myocardium, thus it is possible that the benefits of SGLT2i on heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Furthermore, pharmacokinetics and pharmacodynamics studies on empagliflozin demonstrated that peak plasma levels of empagliflozin in subjects with renal failure/ESRD were similar to those in subjects with normal renal function. The use of empagliflozin in patients with ESRD seemed safe in terms of pharmacokinetics and pharmacodynamics, yet its efficacy remains to be explored.