Chronic kidney disease.
Kamyar Kalantar-Zadeh, Tazeen H Jafar, Dorothea Nitsch...
https://pubmed.ncbi.nlm.nih.gov/34175022/Actively Recruiting
Led by National Taiwan University Hospital · Updated on 2024-12-16
150
Participants Needed
2
Research Sites
156 weeks
Total Duration
Researchers are studying the safety and effects of empagliflozin in patients with end-stage renal disease ESRD who also have heart failure with preserved ejection fraction HFpEF. While SGLT2 inhibitors like empagliflozin have shown benefits in HFpEF, their effects in patients on maintenance dialysis are not well known. This trial aims to explore empagliflozins impact on heart function in this specific group, as previous studies excluded patients with advanced kidney disease. Participants will be randomly assigned to receive either empagliflozin 25 mg once daily or a placebo for six months. The study is single-blinded, meaning participants will not know which treatment they receive. The trial will measure heart function changes over 24 weeks, focusing on diastolic filling velocity ratios and other heart-related volumes and functions. During the study, participants will undergo multiple assessments including heart imaging at 12 and 24 weeks, blood tests measuring NT-proBNP, HbA1c, lipid profiles, and potassium levels at several time points. Quality of life questionnaires, walking tests, heart rate variability, blood pressure, and monitoring for adverse events such as infections and hypoglycemia will also be conducted. The research team will carefully monitor heart health and safety throughout the treatment period, which lasts six months.
CONDITIONS
EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
D
Donna SH Lin, MD
H
Hao-Yun Lo, MD
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National Taiwan University Hospital
Lead Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either Empagliflozin 25 mg or placebo once daily for 6 months.
Visits at 4 weeks, 12 weeks, and 24 weeks during treatment
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborating Sponsor