Clinical Trial

EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease

Study acronym: EMPA-PRED
Recruiting Phase 4
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Summary
The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. The results of mechanistic studies suggest that the benefits of SGLT2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Despite the significance of HFpEF in patients with CKD, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. The effects of SGLT2i in patients under maintenance dialysis are largely unknown. Past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (ESRD) demonstrated that the use of empagliflozin in patients with ESRD seemed safe, yet its efficacy remains to be explored.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-01-31.
Status change: Not Yet Recruiting → Recruiting 2024-12-10
Trial Details
NCT Number NCT06249945
Lead Sponsor National Taiwan University Hospital
Collaborators: Shin Kong Wu Ho-Su Memorial Hospital
Conditions Heart Failure With Preserved Ejection Fraction, End Stage Renal Disease on Dialysis
Enrollment 150 participants
Start Date 2024-03-05
Primary Completion 2027-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-16