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 Preserved Ejection Fraction - a Randomized Controlled Trial
This study tests if the drug empagliflozin can help people with heart failure and severe kidney disease who are on dialysis feel better and improve their heart health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 2 sites (Hsinchu and 1 other locations) |
| Trial ID | NCT06249945 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 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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 and older with end-stage renal disease on stable dialysis and a prior diagnosis of heart failure with preserved ejection fraction.
Not a fit: Patients who are under 20 years old, have severe heart failure symptoms, or have recently experienced significant health complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with heart failure and end-stage renal disease, potentially improving their quality of life and health outcomes.
How similar studies have performed: While SGLT2 inhibitors have shown promise in treating heart failure in other populations, this specific approach in patients with end-stage renal disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hsinchu and 1 other locations
- 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
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.