Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function. (EMPASHOCK)
Cardiogenic Shock
About this trial
This is an interventional treatment trial for Cardiogenic Shock focused on measuring Heart failure, Acute heart failure, Cardiogenic shock, SGLT2 inhibitor, Mortality
Eligibility Criteria
Inclusion Criteria: Adult patients hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock Patient on catecholamine for more than 12 hours and less than 5 days. 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, restrictive, post embolic heart disease. caused by a conduction/rhythm disorder of non-ischemic etiology. related to cardiotropic drug intoxication. secondary to a cardiocirculatory arrest with more than 25 min of "low flow" or more than 5 min of "no flow" before recovery of a stable cardiac activity. Patient undergoing VA-ECMO at admission (before or in whom implantation is imminent (less than 3 hours)). 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))
Sites / Locations
- CHR Metz - Thionville
- CHU de Besançon
- CHU de Dijon Bourgogne
- CHU Lille
- CHU Reims
- Hôpitaux Universitaires de Strasbourg
- CHRU de NANCY
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Empaglifozin in addition to standard management
Standard management
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
Patients in cardiogenic shock receiving a standard management. SGLT2 inhibitor, which are now standard of care in chronic heart failure, in the strict respect of their indications, could be prescribed in the standard management group after hospitalization discharge.