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 ( EMPASHOCK )

Phase 1

• Conditions: Cardiogenic Shock; MedDRA version: 20.0Level: PTClassification code: 10007625Term: Cardiogenic shock Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-503602-37-00
• Lead Sponsor: CHRU De Nancy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Adult patients =18 years old hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock, Patient on catecholamine for more than 12 hours., Person affiliated to a social security scheme

Exclusion Criteria

GFR< 20 ml/min/1.73m2., Women of childbearing age without effective contraception, Type 1 diabete patient, 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)), Chronic dialysis, Patient on SGLT2 inhibitors prior to admission to intensive care unit 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: a. cardiac transplant patient or on transplant list. b. of peripartum, adrenergic, valvular, restrictive, post embolic heart disease. c. caused by a conduction/rhythm disorder of non-ischemic etiology. d. related to cardiotropic drug intoxication. e. 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)).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified