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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital

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

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National Taiwan University Hospital

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Collaborator