Early Use of Empagliflozin for 3 Months in Adults With Cardiogenic Shock to Improve Survival, Heart Function, and Kidney Health

What this Trial Is About

Researchers are studying the effects of early treatment with Empagliflozin in patients experiencing cardiogenic shock, a serious heart condition where the heart suddenly cant pump enough blood. This trial aims to see if adding Empagliflozin to standard care can reduce death, the need for heart transplantation or mechanical assistance, and rehospitalization, while improving heart function over 12 weeks. The study is a randomized, open-label Phase 3 trial sponsored by Central Hospital, Nancy, France. Participants are randomly assigned to receive either Empagliflozin 10 mg daily, taken by mouth or through a tube if intubated, alongside standard management, or standard management alone. The treatment lasts for 12 weeks. After hospitalization, patients in the standard group may receive SGLT2 inhibitors according to routine care guidelines. The trial focuses on the early use of Empagliflozin right after cardiogenic shock. During the study, patients will have heart function monitored by ultrasound to measure left ventricular ejection fraction and other heart performance indicators. Researchers will track outcomes including time to death, heart transplantation, mechanical assistance, and rehospitalization for heart failure within 12 weeks. Kidney function and various blood tests will also be assessed. The total study participation lasts at least 12 weeks after randomization, during which safety and effectiveness measures are closely observed.

Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function.