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NCT Number: NCT05879276

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

Long term prognosis of cardiogenic shock is related to the resolution of haemodynamic failure, associated visceral failure and the recovery of an adequate myocardial function. In the immediate aftermath of cardiogenic shock, after catecholamines weaning, there are no recommendations on cardiovascular treatments that would improve this long term prognosis. Indeed, the standard cardiovascular treatments such as inhibitors of the renin-angiotensin and aldosterone system and beta-blockers have hypotensive and negative inotropic effects and may worsen the renal function. In practice, given their side effects, they are not prescribed in the immediate aftermath of cardiogenic shock.

Sodium-glucose co-transporter 2 (iSGLT2) inhibitors are now an integral part of the drug management of chronic heart failure and the EMPULSE-HF trial has just demonstrated a benefit in acute heart failure (PMID: 35228754). Several pivotal clinical trials have demonstrated a significant effect of iSGLT2 on the survival and the risk of re hospitalisation for heart failure (PMID: 32865377, 31535829, 33200892). Our hypothesis is that, in patients in cardiogenic shock, early treatment with Empaglifozin in addition to the standard management could reduce mortality and morbidity (death, transplantation/LVAD and rehospitalisation for heart failure) and improve myocardial function at 12 weeks, compared with standard management alone.

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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

Interventional

Phase

Phase 3

Primary location

CHR Metz - Thionville, Ars-Laquenexy, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock
  • "Who must have been or is on catecholamines for at least 12 hours for the treatment of cardiogenic shock.
  • Patients who are able to take oral tablets

Exclusion criteria

  • GFR< 20 ml/min/1.73m2.
  • Chronic dialysis.
  • Patient on SGLT2 inhibitors prior to admission to ICU or CCU.
  • Known allergy to SGLT2 inhibitors or to any of its excipients (in particular, patients with hereditary disorders of galactose intolerance, total lactase deficiency or glucose or galactose malabsorption syndrome)
  • Patients on lithium.
  • Patient in shock for another cause or moribund (SAPS2> 90).
  • Specific cardiogenic shock context:
  • cardiac transplant patient or on transplant list.
  • peripartum, adrenergic, valvular, non ischemic, post embolic heart disease.
  • related to cardiotropic drug intoxication.
  • Secondary to a cardiac arrest for which the patient remains comatose prior to inclusion.
  • Women of childbearing age without effective contraception.
  • Person referred to in Articles 10, 31, 32, 33 and 34 of EU Regulation 536/2014 (Pregnant woman, parturient or breastfeeding mother, Minor (not emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice))

Treatment and study plan

Empagliflozin 10 MG

Drug

Patients in cardiogenic shock receiving empagliflozin in addition to standard management at a dose of 10 mg per day per os (or through nasogastric tube in intubated patients) for a duration of 12 weeks.

Primary outcomes

  1. Time to all-cause death

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components:

    • All-cause mortality or heart transplantation or ventricular assist,
    • Rehospitalization for heart failure,
    • Left ventricular ejection fraction.

    Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method):

    • Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist,
    • Rank 2: Time to rehospitalization for heart failure,
    • Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.

  2. Time to cardiac transplantation

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components:

    • All-cause mortality or heart transplantation or ventricular assist,
    • Rehospitalization for heart failure,
    • Left ventricular ejection fraction.

    Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method):

    • Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist,
    • Rank 2: Time to rehospitalization for heart failure,
    • Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.

  3. Time to mechanical ventricular assist

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components:

    • All-cause mortality or heart transplantation or ventricular assist,
    • Rehospitalization for heart failure,
    • Left ventricular ejection fraction.

    Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method):

    • Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist,
    • Rank 2: Time to rehospitalization for heart failure,
    • Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.

  4. Time to rehospitalization for heart failure.

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components:

    • All-cause mortality or heart transplantation or ventricular assist,
    • Rehospitalization for heart failure,
    • Left ventricular ejection fraction.

    Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method):

    • Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist,
    • Rank 2: Time to rehospitalization for heart failure,
    • Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.

  5. Left ventricular ejection fraction assessed by cardiac ultrasound.

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components:

    • All-cause mortality or heart transplantation or ventricular assist,
    • Rehospitalization for heart failure,
    • Left ventricular ejection fraction.

    Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method):

    • Rank 1: Time to all-cause death or cardiac transplantation or mechanical ventricular assist,
    • Rank 2: Time to rehospitalization for heart failure,
    • Rank 3: Left ventricular ejection fraction assessed during a research cardiac ultrasound.

Secondary outcomes

  1. Death

    Time frame: 12-week after randomisation

    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 from randomization

  2. Heart transplantation or long-term ventricular assistance

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on heart transplantation or long-term ventricular assistance, at 12 weeks from randomization

  3. Rehospitalization for heart failure

    Time frame: from hospital discharge to 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on rehospitalization for heart failure, at 12 weeks from randomization

  4. Left ventricular ejection fraction assessed by cardiac ultrasound.

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on left ventricular ejection fraction, at 12 weeks from randomization.

  5. E' wave assessed by cardiac ultrasound

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the left ventricular diastolic function and filling pressures, at 12 weeks from randomization.

  6. E/e' ratio assessed by cardiac ultrasound

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the left ventricular diastolic function and filling pressures, at 12 weeks from randomization.

  7. TAPSE assessed by cardiac ultrasound

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the right ventricular function, at 12 weeks from randomization

  8. S wave at the annular tricuspid level assessed by cardiac ultrasound

    Time frame: 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the right ventricular function, at 12 weeks from randomization

  9. Renal replacement therapy

    Time frame: Randomisation and 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the renal function, at 12 weeks from randomization

  10. Renal function

    Time frame: Randomisation and 12-week after randomisation

    The number of patients requiring renal replacement therapy between randomization and 12 weeks, and change in renal function assessed at baseline and 12 weeks: glomerular filtration rate calculated by the CKD-EPI method

  11. Bilirubin

    Time frame: Randomisation and 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the hepatic function, at 12 weeks from randomization

  12. Prothrombin Ratio (PT)

    Time frame: Randomisation and 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the hepatic function, at 12 weeks from randomization

  13. SGOT

    Time frame: Randomisation and 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the hepatic function, at 12 weeks from randomization

  14. SGPT

    Time frame: Randomisation and 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the hepatic function, at 12 weeks from randomization

  15. NT-Pro-BNP

    Time frame: Randomisation and 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the evolution of the hydro-sodic overload, at 12 weeks from randomization. The measure of NT-Pro-BNP will be measured at 12 weeks and delta from randomisation will be calculated

  16. Weight

    Time frame: Randomisation and 12-week after randomisation

    To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on the evolution of the hydro-sodic overload, at 12 weeks from randomization. The weight will be measured at 12 weeks and delta from randomisation will be calculated

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine KIMMOUN, MD PhD

CONTACT

[email protected]

3 83 15 40 79 ext. +33

Dany JANAH, MD

CONTACT

[email protected]

3 20 44 59 62 ext. +33

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, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function. A Randomized Multicentric Open Trial

Acronym: EMPASHOCK

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 30, 2023
Registry last updated
Jun 27, 2025

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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