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The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1

NCT06030843

RecruitingPhase 2, Phase 3

Sponsor: Chulalongkorn University

Conditions: Empagliflozin in Cardiorenal Syndrome Type 1

Interventions: Empagliflozin 10 MG, Placebo

Countries: Thailand

Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Bangkok, Pathumwan, Thailand