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NCT06030843
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Conditions: Empagliflozin in Cardiorenal Syndrome Type 1
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 200
Sponsor: Chulalongkorn University
Location: Faculty of Medicine, Chulalongkorn University Bangkok Pathumwan
Summary
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06030843). StuddyBuddy aggregates publicly available trial information.