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NCT Number: NCT07450417

Effect of Early Empagliflozin Initiation in Cardiogenic Shock.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chru Nancy

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Hierarchical composite endpoint (Rank 1: Time to all-cause death; Rank 2: Time to rehospitalization for heart failure)

    Time frame: 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

Secondary outcomes

  1. Time to death

    Time frame: 12 weeks

    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

  2. time to rehospitalization for heart failure

    Time frame: 12 weeks

    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

  3. KDIGO score

    Time frame: from admission to 90 days post admission

    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.

  4. Renal replacement therapy

    Time frame: 12 weeks

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on renal replacement therapy

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: EMPASHOCKRETRO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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