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Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD
Description
The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospitalization and to reduce the risk for cardiovascular death in diabetic and non-diabetic patients. Although patients with severe chronic kidney disease and ESKD have very high risk of heart failure and cardiovascular death, they have been excluded from all of the previous studies. If this medication is found to be well tolerated and safe in dialysis patients through this study, future clinical studies can evaluate if this medication can also reduce the risk of heart failure and cardiovascular death in dialysis patients.Patients on dialysis have a very high risk of heart failure and heart-related death compared to people who do not require dialysis. While treatment options for heart failure have
Trial Eligibility
Inclusion Criteria: * include diabetic and non-diabetic adults * dialysis treatment history of ≥3 months Exclusion Criteria: * type 1 diabetes * ongoing intravenous antibiotic therapy for infectious disease * active treatment for malignancy * unhealed lower extremity skin ulceration * history of Fournier's gangrene * diabetic ketoacidosis * severe hypoglycemia (requiring external assistance within the past one year) * allergy to empagliflozin * pregnancy
Study Info
Organization
University of Utah
Primary Outcome
The proportion of participants in each intervention group who remain in follow-up and adhere to the full randomized dose of empagliflozin at the end of the 12-week intervention period.
Interventions
Locations Recruiting
University of Utah
United States, Utah, Salt Lake City
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