NCT06249932 Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Disease
| NCT ID | NCT06249932 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Taiwan University Hospital |
| Condition | Heart Failure with Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2024-03-13 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 95 participants in total. It began in 2024-03-13 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Donna Shu-Han Lin, MD
PRINCIPAL INVESTIGATOR
Shin Kong Wu Ho-Su Memorial Hospital
Frequently Asked Questions
Who can join the NCT06249932 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Heart Failure with Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06249932 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06249932 currently recruiting?
Yes, NCT06249932 is actively recruiting participants. Contact the research team at Donna.lin24@gmail.com for enrollment information.
Where is the NCT06249932 trial being conducted?
This trial is being conducted at Hsinchu, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT06249932 clinical trial?
NCT06249932 is sponsored by National Taiwan University Hospital. The principal investigator is Donna Shu-Han Lin, MD at Shin Kong Wu Ho-Su Memorial Hospital. The trial plans to enroll 95 participants.
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