Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05879276

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

Led by Central Hospital, Nancy, France · Updated on 2025-06-27

164

Participants Needed

8

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock
  • Patients who have been or are on catecholamines for at least 12 hours for cardiogenic shock
  • Patients who are able to take oral tablets
Not Eligible

You will not qualify if you...

  • Glomerular filtration rate (GFR) less than 20 ml/min/1.73m2
  • Patients on chronic dialysis
  • Patients already using SGLT2 inhibitors before ICU or CCU admission
  • Known allergy to SGLT2 inhibitors or related substances
  • Patients taking lithium
  • Patients in shock from other causes or moribund with SAPS2 greater than 90
  • Cardiogenic shock due to specific causes: cardiac transplant or on transplant list; peripartum, adrenergic, valvular, non-ischemic, or post embolic heart disease; cardiotropic drug intoxication; comatose after cardiac arrest
  • Women of childbearing age without effective contraception
  • Pregnant or breastfeeding women, minors not emancipated, or adults under legal protection measures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

CHR Metz - Thionville

Ars-Laquenexy, France, 57000

Actively Recruiting

2

CHU de Besançon

Besançon, France, 25000

Actively Recruiting

3

CHU de Dijon Bourgogne

Dijon, France, 21000

Not Yet Recruiting

4

CHU Lille

Lille, France, 59000

Not Yet Recruiting

5

CHU Reims

Reims, France, 51000

Not Yet Recruiting

6

Hôpitaux Universitaires de Strasbourg

Strasbourg, France, 67000

Actively Recruiting

7

CHRU de NANCY - réanimation médicale

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

8

Chru Nancy - Usic

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

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Research Team

A

Antoine KIMMOUN, MD PhD

CONTACT

D

Dany JANAH, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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