The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Recruiting · NCT06030843 · Interventional (participants receive a specific treatment) · Lead sponsor: Chulalongkorn University
View the official record on ClinicalTrials.gov →Interventions studied
Empagliflozin 10 MGPlacebo
What this trial is about
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Faculty of Medicine, Chulalongkorn University - Bangkok, Pathumwan, Thailand