RecruitingPhase 4NCT06249932

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

The Safety and Efficacy of Empagliflozin in Patients with End-stage Renal Disease and Heart Failure with Reduced Ejection Fraction - a Randomized Controlled Trial


Sponsor

National Taiwan University Hospital

Enrollment

95 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether empagliflozin (a drug originally developed for diabetes and heart failure) is safe and helpful for people who have both heart failure with reduced pumping ability and end-stage kidney disease (requiring dialysis). Most heart failure drug trials have excluded dialysis patients, so this is an important gap in evidence. **You may be eligible if...** - You are 20 or older - You have end-stage kidney disease and are on regular hemodialysis with a stable weight for at least 6 months - You have confirmed heart failure with reduced ejection fraction (heart pumps less than 50% of blood per beat) **You may NOT be eligible if...** - You have very severe heart failure (NYHA Class IV — unable to do any activity without symptoms) - You were hospitalized for heart failure in the past month - You have had a heart attack, stroke, or TIA in the past month - You have an active urinary tract or genital infection - You have severe peripheral artery disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 25 MG

The medication will be packed in a customized sealed jar and labeled on the exterior of the jar.

DRUGPlacebo

The placebo tablet is manufactured by Prince Pharmaceutical Co., Ltd, a leading manufacturer of nutritional supplements with certifications including cGMP, GMP, ISO, and HACCP. The Prince Pharmaceutical also provides Original Equipment Manufacturing (OEM)/Original Design Manufacturing (ODM) services for a wide array of tablet shapes, and post-processing techniques such as film coating and sugar coating.


Locations(2)

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan, Taiwan

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06249932


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