Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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