Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Disease (EMPA-RRED)

National Taiwan University

Status and phase: Enrolling; Phase 4

Conditions: Heart Failure with Reduced Ejection Fraction; End Stage Renal Disease on Dialysis

Treatments: Drug: Empagliflozin 25 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06249932

202301140MINC

Details and patient eligibility

About

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.

Enrollment: 95 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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 ≥50% 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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95 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