Effect of Early Empagliflozin Initiation in Cardiogenic Shock.

Condition(s) studied

Investigational drug(s) / intervention(s)

Patient in cardiogenic shock treated or not early with SGLT2 inhibitors.: Patient in cardiogenic shock hospitalized and treated or not early with SGLT2 inhibitors

Study summary

Cardiogenic shock represents a severe condition of heart pump dysfunction. Despite advances in medical management, the mortality rate for this condition remains high. Conventional treatments for cardiovascular diseases have several side effects that make their use impossible in patients with cardiogenic shock.

A new class of drugs has been developed in recent years and is an integral part of the management of patients with chronic heart failure. These are sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), namely empagliflozin and dapagliflozin. This therapeutic class has proven effective in reducing mortality as well as hospital readmissions for heart failure patients. Given their effectiveness in acute heart failure, which is physiologically closest to the cardiogenic shock population, and their good tolerance, SGLT2 inhibitors are increasingly being prescribed to patients with cardiogenic shock to improve long-term outcomes.

In order to improve medical knowledge and the management of patients in cardiogenic shock, the main objective of this research is to compare, in these patients, the effect of the early introduction of treatment with sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), in addition to usual care, versus usual care alone, on all-cause mortality and rehospitalization for heart failure at 12 weeks.

Eligibility

Primary outcome measure(s)

• Hierarchical composite endpoint (Rank 1: Time to all-cause death; Rank 2: Time to rehospitalization for heart failure) — 12 weeks
  To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1- All-cause mortality 2-rehospitalization for heart failure

Trial sites (1)

More Central Hospital, Nancy, France trials in France

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