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EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
Sponsor: National Taiwan University Hospital
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.
Official title: The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Preserved Ejection Fraction - a Randomized Controlled Trial
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-03-05
Completion Date
2030-12-31
Last Updated
2024-12-16
Healthy Volunteers
No
Interventions
Empagliflozin 25 MG
The medication will be packed in a customized sealed jar and labeled on the exterior of the jar.
Placebo
The placebo tablet is manufactured by Prince Pharmaceutical Co., Ltd, a leading manufacturer of nutritional supplements with certifications including cGMP, GMP, ISO, and HACCP. The Prince Pharmaceutical also provides Original Equipment Manufacturing (OEM)/Original Design Manufacturing (ODM) services for a wide array of tablet shapes, and post-processing techniques such as film coating and sugar coating.
Locations (2)
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan