The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Preserved Ejection Fraction - a Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
National Taiwan University Hospital Hsinchu Branch
RECRUITING
Hsinchu
Shin Kong Wu Ho-Su Memorial Hospital
RECRUITING
Taipei
Contact Information
Primary
Donna SH Lin, MD
Donna.lin24@gmail.com
+886912902379
Backup
Hao-Yun Lo, MD
limoonby@gmail.com
+886972234640
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 150
Treatments
Experimental: empagliflozin
Jardiance, 25 mg, QD, for 6 months
Placebo_comparator: Placebo
QD, for 6 months
Sponsors
Collaborators: Shin Kong Wu Ho-Su Memorial Hospital
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov