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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 )
EU CTIS ID: 2023-503602-37-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.