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Clinical Trial Details

Trial ID: L1509
Source ID: NCT06249945
Associated Drug: Empagliflozin 25 Mg
Title: EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
Acronym: EMPA-PRED
Status: RECRUITING
Study Results: NO
Results:
Conditions: Heart Failure With Preserved Ejection Fraction|End Stage Renal Disease on Dialysis
Interventions: DRUG: Empagliflozin 25 MG|DRUG: Placebo
Outcome Measures: Primary: Mitral early (E) and late (A) diastolic filling velocity ratio (E/A), As assessed by echocardiography, performed on non-dialysis day, 24 weeks of treatment | Secondary: LV end-systolic volume index, As assessed by echocardiography, performed on non-dialysis day, 12 weeks and 24 weeks of treatment|LV end-diastolic volume index, As assessed by echocardiography, performed on non-dialysis day, 12 weeks and 24 weeks of treatment|LA volume index, As assessed by echocardiography, performed on non-dialysis day, 12 weeks and 24 weeks of treatment|LV ejection fraction, As assessed by echocardiography, performed on non-dialysis day, 12 weeks and 24 weeks of treatment|Left ventricular mass index, As assessed by echocardiography, performed on non-dialysis day, 12 weeks and 24 weeks of treatment|Global longitudinal strain, As assessed by echocardiography, performed on non-dialysis day, 12 weeks and 24 weeks of treatment|LA strain, As assessed by echocardiography, performed on non-dialysis day, 12 weeks and 24 weeks of treatment|Mitral inflow deceleration time, As assessed by echocardiography, performed on non-dialysis day, 12 weeks and 24 weeks of treatment|Mitral inflow deceleration time LV relative wall thickness, As assessed by echocardiography, performed on non-dialysis day, 12 weeks and 24 weeks of treatment|Tricuspid regurgitation peak gradient (TRPG), As assessed by echocardiography, performed on non-dialysis day, 12 weeks and 24 weeks of treatment|NT-proBNP, Blood tests obtained pre-dialysis session, 4 weeks, 12 weeks and 24 weeks of treatment|HbA1c, Blood tests obtained pre-dialysis session, 4 weeks, 12 weeks and 24 weeks of treatment|Lipid profile, Blood tests obtained pre-dialysis session, 4 weeks, 12 weeks and 24 weeks of treatment|KCCQ-OS, Performed on non-dialysis day, 12 weeks and 24 weeks of treatment|6-minute walking distance, Performed on non-dialysis day, 12 weeks and 24 weeks of treatment|3-minute heart rate variability, During hemodialysis session, 12 weeks and 24 weeks of treatment|Blood pressure, Obtained pre-dialysis session, 12 weeks and 24 weeks of treatment|Major adverse cardiovascular events (composite of CV death, myocardial infarction, stroke), By medical record confirmation and by interview, 24 weeks of treatment|Lower extremity non-traumatic amputation or revascularization, By medical record confirmation and by interview, 24 weeks of treatment|All-cause mortality, By medical record confirmation and by interview, 24 weeks of treatment|Hospitalization for heart failure, By medical record confirmation and by interview, 24 weeks of treatment|Hypoglycemic events, By medical record confirmation and by interview, 24 weeks of treatment|Diabetic ketoacidosis, By medical record confirmation and by interview, 24 weeks of treatment|Urinary tract infection, By medical record confirmation and by interview, 24 weeks of treatment|Genital tract infection, By medical record confirmation and by interview, 24 weeks of treatment|Hypokalemia, Blood tests obtained pre-dialysis session, 4 weeks, 12 weeks and 24 weeks of treatment
Sponsor/Collaborators: Sponsor: National Taiwan University Hospital | Collaborators: Shin Kong Wu Ho-Su Memorial Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 150
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-05
Completion Date: 2030-12-31
Results First Posted:
Last Update Posted: 2024-12-16
Locations: National Taiwan University Hospital Hsinchu Branch, Hsinchu, 300, Taiwan|Shin Kong Wu Ho-Su Memorial Hospital, Taipei, 111, Taiwan
URL: https://clinicaltrials.gov/show/NCT06249945