Effect of Early Empagliflozin Initiation in Cardiogenic Shock.

NCT07450417 | Active Not Recruiting

• 1 other identifier: 2022PI106
• Study Type: observational
• Target: 418
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiogenic Shock

Keywords

heart failure; acute heart failure; SGLT2 inhibitor; Mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to death

  12 weeks

• time to rehospitalization for heart failure

  12 weeks

• KDIGO score

  from admission to 90 days post admission

• Renal replacement therapy

  12 weeks

Study Arms (1)

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.

Interventions

Patient in cardiogenic shock treated or not early with SGLT2 inhibitors. DRUG

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

Patient in cardiogenic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Chru Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Failure

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Nicolas GIRERD, MD PHD

  CHRU de NANCY

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 4, 2026
• Study Start: March 10, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

FR (1)