Empagliflozin in Cardiorenal Syndrome Type 1
Conditions
Keywords
Empagliflozin, SGLT2i, Cardiorenal syndrome, ADHF, AKI
Brief summary
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
Interventions
DRUGEmpagliflozin 10 MG
Empagliflozin 10 MG
DRUGPlacebo
Matching placebo containing Lactose content (0.26 gram)
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAKE30 | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality rate | During admission | In-hospital mortality rate |
| 30-days mortality rate | 30 days | 30-days mortality rate |
| Initiation of Renal Replacement therapy | 30 days | Initiation of Renal Replacement therapy |
| 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 | Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR |
| Recurrent heart failure | 30 days | Recurrent heart failure required hospital administration |
| Vasoactive drug | 30 days | Vasoactive drug use |
| Mechanical ventilation | 30 days | Mechanical ventilation use |
| Ventricular tachycardia or ventricular fibrillation | 30 days | Ventricular tachycardia or ventricular fibrillation |
| Resuscitation following a cardiac arrest | 30 days | Resuscitation following a cardiac arrest |
| Reduction of prespecified renal biomarkers | 30 days | Reduction of prespecified renal biomarkers |
Countries
Thailand
Contacts
CONTACTSasipha Tachaboon
PRINCIPAL_INVESTIGATORNattachai Srisawat
Chulalongkorn University
Outcome results
None listed