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 preserved ejection fraction (HFpEF) who are also undergoing chronic maintenance dialysis for end-stage renal disease (ESRD). The study aims to determine the safety and efficacy of empagliflozin in this unique patient population, which has been largely excluded from previous research. Participants will receive either empagliflozin or a placebo while being monitored for improvements in heart function and overall health. The trial seeks to fill a significant gap in treatment options for patients with both HFpEF and ESRD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥20 years old
* ESRD under chronic, maintenance dialysis with stable dry weight for the past 6 months
* Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnostic algorithm.

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 =\<40% by any imaging modality within 1 month of screening
* Refused informed consent

Where it's running

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

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Coated Aldehyde Oxystarch to lower PBUTs in adults on dialysis

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• Incretin therapy with tirzepatide for obesity-related HFpEF

  A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07554638

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.