About this trial
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.
Eligibility criteria
Qualifiers
Age ≥20 years old
ESRD under chronic, maintenance dialysis with stable dry weight for the past 6 months
Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnostic algorithm.
Disqualifiers
Age <20 years old
Ongoing pregnancy
NYHA class IV heart failure
Any hospitalization for heart failure within the past month Ongoing acute urinary tract infection at the time of screening
Trial design
Treatments tested in this trial
- Empagliflozin 25 MG
- Placebo
Treatment groups
Sponsors and collaborators
National Taiwan University Hospital
Lead sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborator