Effect of Early Empagliflozin Initiation in Cardiogenic Shock. (EMPASHOCKRETRO)

Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality and Rehospitalization. Retrospective Monocentric Trial.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Drug: Patient in cardiogenic shock treated or not early with SGLT2 inhibitors.

• Study Type: Observational
• Enrollment (Estimated): 418

Contacts and Locations

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54500
    • CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in Intensive Care or Cardiac Intensive Care at the CHRU of Nancy between January 1, 2018, and December 31, 2023, for cardiogenic shock.

Description

Inclusion Criteria:

• Patients over 18 years old;
• Hospitalized in an Intensive Care or Cardiac Intensive Care unit in cardiogenic shock;
• Hospitalized at CHRU of NANCY between 01/01/2018 and 31/12/2023.

Exclusion Criteria:

At admission to intensive care/cardiac intensive care for cardiogenic shock:

• eGFR < 20 ml/min/1.73m²
• Chronic dialysis patient
• Patient on SGLT2 inhibitors prior to admission to intensive care or cardiac intensive care
• Cardiogenic shock:
• a) From peripartum cardiomyopathy, adrenergic, restrictive, or post-embolic
• b) Due to drug-induced cardiotoxicity
• c) Secondary to a cardiac arrest with more than 25 minutes of "low flow" or more than 5 minutes of "no flow" before recovery of stable cardiac activity
• Adult subject under a legal protective measure (guardianship, curatorship, judicial safeguard)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient in cardiogenic shock; Patients hospitalized in Intensive Care or Cardiac Intensive Care at the CHRU of Nancy between January 1, 2018, and December 31, 2023, for cardiogenic shock and treated or not early with SGLT2 inhibitors.	Drug: Patient in cardiogenic shock treated or not early with SGLT2 inhibitors.; Patient in cardiogenic shock hospitalized and treated or not early with SGLT2 inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hierarchical composite endpoint (Rank 1: Time to all-cause death; Rank 2: Time to rehospitalization for heart failure)	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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to death	To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on all-cause mortality at 12 weeks	12 weeks
time to rehospitalization for heart failure	To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on time to rehospitalization for heart failure, at 12 weeks	12 weeks
KDIGO score	To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on Acute kidney injury onset defined by the maximal KDIGO score reached in intensive care unit.	from admission to 90 days post admission
Renal replacement therapy	To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on renal replacement therapy	12 weeks

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Chair: Nicolas GIRERD, MD PHD, CHRU de Nancy

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: heart failure; Mortality; acute heart failure; SGLT2 inhibitor
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Heart Failure; Shock, Cardiogenic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Pharmacologic Actions; Chemical Actions and Uses; Sodium-Glucose Transporter 2 Inhibitors
• Other Study ID Numbers: 2022PI106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No