Tests empagliflozin in dialysis patients with a type of heart failure
Tests empagliflozin against placebo in adults on dialysis with heart failure and preserved ejection fraction.
Plain-language title generated from the registry record
Registry title: EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
Key facts
- Where
- Hsinchu and Taipei, TaiwanSee the 2 sites
- Phase
- Phase 4
Where in Taiwan
- National Taiwan University Hospital - Hsinchu branchHsinchu, TaiwanTaking people
- Shin Kong Wu Ho Su Memorial HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT06249945
- Record updated
- 16 December 2024
- Original description
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.Read full original descriptionShow less
The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Preserved Ejection Fraction - a Randomized Controlled Trial
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.
Inclusion: 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: 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; Documented left ventricular ejection fraction =<40% by any imaging modality within 1 month of screening; Age <20 years old; 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.