NCT06249932RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and 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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality. Several drug classes that provide survival benefits for patients with HFrEF, including SGLT2i, lack data regarding their efficacy and safety in patients under chronic hemodialysis. As the primary target of SGLT2i is expressed mostly in the kidneys, the efficacy of SGLT2i in patients with ESRD may be limited. On the other hand, patients with ESRD are at higher risks of experiencing cardiovascular events and may still benefit from treatment. Several mechanistic studies have demonstrated direct actions of SGLT2i on the myocardium, thus it is possible that the benefits of SGLT2i on heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Furthermore, pharmacokinetics and pharmacodynamics studies on empagliflozin demonstrated that peak plasma levels of empagliflozin in subjects with renal failure/ESRD were similar to those in subjects with normal renal function. The use of empagliflozin in patients with ESRD seemed safe in terms of pharmacokinetics and pharmacodynamics, yet its efficacy remains to be explored.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 95 (estimated)
- First submitted
- 19 Jan 2024
- Start date
- 13 Mar 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT06249932
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 95
- From 13 Mar 2024 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Documented left ventricular ejection fraction ≥50% by any imaging modality within 1 month of screening
Age
- Age \<20 years old
Other
- Ongoing pregnancy
- 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
- Refused informed consent
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital - Hsinchu branch Coordinator of this site? Confirm its status | Hsinchu | Taiwan | Recruiting |
| Shin Kong Wu Ho Su Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.