RecruitingPhase 2Phase 3NCT06030843
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Sponsor
Chulalongkorn University
Enrollment
200 participants
Start Date
Mar 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Age 18 years or more
- Hospitalized for the primary diagnosis of acute denovo or decompensated chronic heart regardless of ejection fraction
- AKI KDIGO any stage or urine NGAL ≥ 150 ng/mL
- Must be able to be enrolled into the trial ≤ 12 hours of diagnosis of AKI or elevated urine NGAL
Exclusion Criteria14
- Denied to participate in the study
- Cardiogenic shock or unstable hemodynamic (systolic blood pressure of at least 100 mmHg or required inotropic support within last 24 hours)
- Cardiac mechanical support (i.e. extracorporeal membrane oxygenation and intra-aortic balloon pump)
- Acute coronary syndrome
- Diagnosed with cause of AKI other than cardiorenal syndrome (eg. sepsis, nephrotoxic, dehydration)
- Anuria or requiring dialysis or expected to required dialysis within 24 hr
- Baseline eGFR ≤ 20 ml/min/1.73m2 with or without dialysis initiated
- Heart or kidney transplanted
- Previously received any SGLT2i in the last 3 months before admission
- Allergic to any SGLT2i
- Type 1 diabetes mellitus
- History of ketoacidosis, including diabetic ketoacidosis
- Pregnancy
- Comorbid conditions with an expected survival of less than 1 months such as end-stage liver or heart disease, or uncurable malignancy
Interventions
DRUGEmpagliflozin 10 MG
Empagliflozin 10 MG
DRUGPlacebo
Matching placebo containing Lactose content (0.26 gram)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06030843