NCT06249945RecruitingPhase 4
EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and 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
Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 21 Jan 2024
- Start date
- 5 Mar 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT06249945
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From 5 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 =\<40% 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 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.
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.