Using empagliflozin to treat heart failure in patients with end stage renal disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of empagliflozin, a sodium-glucose co-transporter 2 inhibitor, on patients suffering from heart failure with reduced ejection fraction (HFrEF) who are also undergoing chronic hemodialysis for end stage renal disease (ESRD). The study aims to determine the safety and efficacy of empagliflozin in this unique patient population, as traditional treatments may not be effective. Participants will receive either empagliflozin or a placebo, and their heart function will be monitored over the course of the trial. The research seeks to explore whether the benefits of empagliflozin can extend beyond its glycosuric actions, potentially improving cardiovascular outcomes in these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• National Taiwan University Hospital Hsinchu Branch
  Hsinchu, Taiwan, Taiwan Recruiting
• Shin Kong Wu Ho-Su Memorial Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Donna Shu-Han Lin, MD — Shin Kong Wu Ho-Su Memorial Hospital
• Study coordinator: Donna Shu-Han Lin, MD
• Email: Donna.lin24@gmail.com
• Phone: +886912902379

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.