EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease (EMPA-PRED)

National Taiwan University

Status and phase: Enrolling; Phase 4

Conditions: Heart Failure With Preserved Ejection Fraction; End Stage Renal Disease on Dialysis

Treatments: Drug: Empagliflozin 25 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06249945

202301126MINC

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Known acute genital infection
• Severe peripheral artery disease (Rutherford category 4-6)
• Acute coronary syndrome, stroke or transient ischemic attack within the past month
• Recent initiation of chronic maintenance hemodialysis within 6 months
• Adjustment of dry weight with changes greater than 5% of body weight within the past month
• Documented left ventricular ejection fraction =<40% by any imaging modality within 1 month of screening
• Refused informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

empagliflozin

Experimental group

Description:

Jardiance, 25 mg, QD, for 6 months

Treatment:

Drug: Empagliflozin 25 MG

Placebo

Placebo Comparator group

Description:

QD, for 6 months

Treatment:

Drug: Placebo