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Search / Trial NCT06249932

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

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Jan 31, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

End Stage Renal Disease Sodium Glucose Co Transporter 2 Inhibitors, Heart Failure With Reduced Ejection Fraction Empagliflozin Left Ventricular Mass

ClinConnect Summary

This clinical trial is studying the use of a medication called empagliflozin in adults with heart failure and severe kidney disease who are on dialysis. Heart failure with reduced ejection fraction (HFrEF) means the heart doesn't pump blood as well as it should, and end-stage renal disease (ESRD) means the kidneys have lost most of their function. The trial aims to find out if empagliflozin can help improve heart health in these patients, even though traditional treatments for heart failure have not been well studied in people undergoing dialysis.

To participate in this trial, you need to be at least 20 years old, have been on stable dialysis for at least six months, and have a specific test result showing your heart's ejection fraction is below 50%. Participants in the study will receive the medication and will be closely monitored to see how it affects their heart and overall health. It's important to know that this trial is currently looking for participants, and if you meet the criteria, your involvement could contribute valuable information about treating heart failure in patients with kidney disease.

Gender

ALL

Eligibility criteria

  • 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

About National Taiwan University Hospital

National Taiwan University Hospital (NTUH) is a leading medical institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a pioneer in medical education and patient care in Taiwan, NTUH integrates cutting-edge technology with comprehensive clinical expertise to facilitate groundbreaking studies across various medical fields. The hospital’s dedicated research team collaborates with local and international partners to enhance the understanding of diseases and improve treatment outcomes. By prioritizing patient safety and ethical standards, NTUH strives to contribute to the global medical community and foster advancements in healthcare practices.

Locations

Taipei, , Taiwan

Hsinchu City, , Taiwan

Patients applied

0 patients applied

Trial Officials

Donna Shu-Han Lin, MD

Principal Investigator

Shin Kong Wu Ho-Su Memorial Hospital

Chih-Cheng Wu, MD. PhD

Principal Investigator

National Taiwan University Hsin-Chu Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported