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

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

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥20 years old

ESRD under chronic, maintenance hemodialysis with stable dry weight for the past 6 months

Documented left ventricular ejection fraction <50% by any imaging modality within 1 month of screening

Disqualifiers

Age <20 years old

Ongoing pregnancy

NYHA class IV heart failure

Any hospitalization for heart failure within the past month

Trial design

Treatments tested in this trial

  • Empagliflozin 25 MG
  • Placebo

Treatment groups

95 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National Taiwan University Hospital

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Collaborator