NCT06249945 EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
| NCT ID | NCT06249945 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Taiwan University Hospital |
| Condition | Heart Failure With Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-03-05 |
| 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 150 participants in total. It began in 2024-03-05 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
The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. The results of mechanistic studies suggest that the benefits of SGLT2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Despite the significance of HFpEF in patients with CKD, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. The effects of SGLT2i in patients under maintenance dialysis are largely unknown. Past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (ESRD) demonstrated that the use of empagliflozin in patients with ESRD seemed safe, yet its efficacy remains to be explored.
Eligibility 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
Contact & Investigator
Donna SH Lin, MD
PRINCIPAL INVESTIGATOR
Shin Kong Wu Ho-Su Memorial Hospital
Frequently Asked Questions
Who can join the NCT06249945 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Heart Failure With Preserved 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 NCT06249945 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 NCT06249945 currently recruiting?
Yes, NCT06249945 is actively recruiting participants. Contact the research team at Donna.lin24@gmail.com for enrollment information.
Where is the NCT06249945 trial being conducted?
This trial is being conducted at Hsinchu, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT06249945 clinical trial?
NCT06249945 is sponsored by National Taiwan University Hospital. The principal investigator is Donna SH Lin, MD at Shin Kong Wu Ho-Su Memorial Hospital. The trial plans to enroll 150 participants.
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