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

RecruitingPhase 4Ages 20 Years - anyAllNational Taiwan University Hospital
NCT06249932 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pea

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📋 Eligibility rules (as published)
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
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What it tests

  • Empagliflozin 25 MG
  • Placebo
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Where

2 sites
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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