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Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06030843). StuddyBuddy aggregates publicly available trial information.