Status:
RECRUITING
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Lead Sponsor:
Chulalongkorn University
Conditions:
Empagliflozin in Cardiorenal Syndrome Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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 criteria
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06030843
Start Date
March 1 2025
End Date
December 31 2026
Last Update
August 7 2025
Active Locations (1)
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1
Faculty of Medicine, Chulalongkorn University
Bangkok, Pathumwan, Thailand, 10330