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 )
- Conditions
- Cardiogenic Shock
- Registration Number
- 2023-503602-37-00
- Lead Sponsor
- CHRU De Nancy
- Brief Summary
To compare the effect of early introduction of empagliflozin in addition to usual management versus usual management alone at 12 weeks on a hierarchical composite morbidity endpoint including all-cause death or transplantation or long-term mechanical assistance or rehospitalization for heart failure and left ventricular ejection fraction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Not specified
- Target Recruitment
- 164
Adult patients ≥18 years old hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock
Who must have been or is under catecholamine for at least 12 hours for the treatment of cardiogenic shock. The definition of cardiogenic shock is as follows, adapted from the SHARC expert consensus: it refers to a patient with cardiac dysfunction resulting in a systolic blood pressure lower than 90 mmHg for at least 30 minutes (or requiring the use of vasopressors, inotropes, or mechanical circulatory support to maintain a systolic blood pressure of at least 90 mmHg) with evidence of hypoperfusion (≥ 1): •Elevated arterial lactate (>2 mmol/L), • Acute renal failure (creatinine ≥ 2x the upper normal limit) or oliguria (e.g., urine output <0.5 mL/kg/h), • Acute liver failure (e.g., AST and/or ALT > 3x the upper normal limit), • Cold extremities or mottling or capillary refill time (CRT) ≥ 3 seconds, •Altered consciousness unexplained by another cause.
Person affiliated to a social security scheme
GFR< 20 ml/min/1.73m2.
Specific cardiogenic shock context: a. cardiac transplant patient or on transplant list. b. of peripartum, adrenergic, non ischemic valvular, post embolic heart disease. c. related to cardiotropic drug intoxication. d. secondary to a cardiocirculatory arrest for which the patient remains comatose before inclusion..
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): - Rank 1: time to all-cause death or heart transplant or mechanical ventricular assist. - Rank 2: time to rehospitalization for heart failure - Rank 3: left ventricular ejection fraction assessed by echocardiography Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): - Rank 1: time to all-cause death or heart transplant or mechanical ventricular assist. - Rank 2: time to rehospitalization for heart failure - Rank 3: left ventricular ejection fraction assessed by echocardiography
- Secondary Outcome Measures
Name Time Method Death at 12 weeks Death at 12 weeks
Heart transplantation or long-term ventricular assistance at 12 weeks Heart transplantation or long-term ventricular assistance at 12 weeks
Rehospitalization for heart failure from hospital discharge to 12-week Rehospitalization for heart failure from hospital discharge to 12-week
Left ventricular ejection fraction at 12 weeks Left ventricular ejection fraction at 12 weeks
Left ventricular relaxation and filling pressures assessed at 12 weeks: e' wave, E/e' ratio, Left ventricular relaxation and filling pressures assessed at 12 weeks: e' wave, E/e' ratio,
Right ventricular function assessed at 12 weeks: TAPSE, S wave Right ventricular function assessed at 12 weeks: TAPSE, S wave
Number of patients requiring extra-renal purification between randomization and 12 weeks, and evolution of renal function assessed at randomization and at 12 weeks: glomerular filtration rate calculated by the CKD-EPI method Number of patients requiring extra-renal purification between randomization and 12 weeks, and evolution of renal function assessed at randomization and at 12 weeks: glomerular filtration rate calculated by the CKD-EPI method
Liver function assessed at randomization and at 12 weeks: Bilirubin, Prothrombin Ratio , SGOT, SGPT. Liver function assessed at randomization and at 12 weeks: Bilirubin, Prothrombin Ratio , SGOT, SGPT.
Weight and NT-proBNP (at randomization and at 12 weeks). Weight and NT-proBNP (at randomization and at 12 weeks).
Trial Locations
- Locations (7)
CHRU De Nancy
🇫🇷Vandoeuvre Les Nancy, France
Centre Hospitalier Universitaire Reims
🇫🇷Reims Cedex, France
Centre Hospital Region Metz Thionville
🇫🇷Metz Cedex 03, France
Besancon University Hospital Center
🇫🇷Besancon Cedex, France
Centre Hospitalier Universitaire De Lille
🇫🇷Lille, France
Les Hopitaux Universitaires De Strasbourg
🇫🇷Strasbourg Cedex, France
Centre Hospitalier Universitaire De Dijon
🇫🇷Dijon, France
CHRU De Nancy🇫🇷Vandoeuvre Les Nancy, FranceAntoine KIMMOUNSite contact+33383154079a.kimmoun@chru-nancy.frBatric POPOVICSite contact+33383154615b.popovic@chru-nancy.fr