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

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

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

Conditions
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Empagliflozin in Cardiorenal Syndrome Type 1

Intervention / Treatment
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* Drug: Empagliflozin 10 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empagliflozin<br>Empagliflozin 10 mg po OD | Drug: Empagliflozin 10 MG<br>* Empagliflozin 10 MG<br>|
| Placebo Comparator: Placebo<br>Matching placebo | Drug: Placebo<br>* Matching placebo containing Lactose content (0.26 gram)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAKE30 | The composite outcome of death, new dialysis, and sustained loss of kidney function (which was defined as a 25% or greater decline in eGFR from baseline) assess at 30 days following randomization | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality rate | In-hospital mortality rate | During admission | 
| 30-days mortality rate | 30-days mortality rate | 30 days | 
| Initiation of Renal Replacement therapy | Initiation of Renal Replacement therapy | 30 days | 
| Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR | Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR | 30 days | 
| Recurrent heart failure | Recurrent heart failure required hospital administration | 30 days | 
| Vasoactive drug | Vasoactive drug use | 30 days | 
| Mechanical ventilation | Mechanical ventilation use | 30 days | 
| Ventricular tachycardia or ventricular fibrillation | Ventricular tachycardia or ventricular fibrillation | 30 days | 
| Resuscitation following a cardiac arrest | Resuscitation following a cardiac arrest | 30 days | 
| Reduction of prespecified renal biomarkers | Reduction of prespecified renal biomarkers | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Empagliflozin, SGLT2i, Cardiorenal syndrome, ADHF, AKI