Using empagliflozin to treat heart failure in patients with 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
This study is testing if empagliflozin can help people with heart failure who are on dialysis feel better and improve their heart function.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 2 sites (Hsinchu, Taiwan and 1 other locations) |
| Trial ID | NCT06249932 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 and older with end stage renal disease on chronic hemodialysis and a documented left ventricular ejection fraction of less than 50%.
Not a fit: Patients who are under 20 years old, have NYHA class IV heart failure, or have had recent hospitalizations for heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and reduce cardiovascular events in patients with both HFrEF and ESRD.
How similar studies have performed: While there is limited data on the use of SGLT2 inhibitors in patients on hemodialysis, mechanistic studies suggest potential benefits, making this approach both novel and promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hsinchu, Taiwan and 1 other locations
- National Taiwan University Hospital Hsinchu Branch — Hsinchu, Taiwan, Taiwan (Recruiting)
- Shin Kong Wu Ho-Su Memorial Hospital — Taipei, Taiwan, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.