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EMPASHOCK: Empagliflozin in Cardiogenic Shock
NCT05879276Phase 3
Key facts
- Status
- Recruiting
- Start
- Dec 2024
- Primary completion
- Mar 2027
- Countries
- 1
- Sponsor
- CHRU de Nancy - Hôpital Central
- Modality
- Small Molecules
- Drugs
- empagliflozin
- Conditions
- cardiogenic shock
01
Overview
Phase 3, randomised, open-label trial of empagliflozin in cardiogenic shock (2 arms), sponsored by CHRU de Nancy - Hôpital Central. Primary endpoints: Time to all-cause death at 12 weeks, Time to cardiac transplantation at 12 weeks and 3 more. Started Dec 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Empagliflozin Arm
Empagliflozin 10 mg/day + Standard Care
Standard Care Arm
Standard Care alone
03
Who it enrols
Adult patients with cardiogenic shock on catecholamines for at least 12 hours, excluding those with severe renal impairment (GFR < 20), chronic dialysis, prior SGLT2 inhibitor use, or specific shock etiologies.
04
Endpoints
Primary
Time to all-cause death
Time to cardiac transplantation
Time to mechanical ventricular assist
Time to rehospitalization for heart failure
Left ventricular ejection fraction
Secondary
All-cause death
Heart transplantation or long-term ventricular assistance
Rehospitalization for heart failure
Left ventricular ejection fraction
E' wave assessed by cardiac ultrasound
E/e' ratio assessed by cardiac ultrasound
TAPSE assessed by cardiac ultrasound
S wave at the annular tricuspid level
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