The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1 (TREAT-CRS)

Chulalongkorn University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Empagliflozin in Cardiorenal Syndrome Type 1

Treatments: Drug: Empagliflozin 10 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06030843

IRB 674/66

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Empagliflozin

Experimental group

Description:

Empagliflozin 10 mg po OD

Treatment:

Drug: Empagliflozin 10 MG

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo