EMPAGLIFLOZIN for Cardiogenic shock

Inclusion criteria

• {"criterion_text":"- Adult patients ≥18 years old hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock\n- 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.\n- Person affiliated to a social security scheme"}

Exclusion criteria

• {"criterion_text":"- GFR< 20 ml/min/1.73m2."}
• {"criterion_text":"- 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.."}
• {"criterion_text":"- Women of childbearing age without effective contraception"}
• {"criterion_text":"- Type 1 diabete patient"}
• {"criterion_text":"- 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))"}
• {"criterion_text":"- Chronic dialysis"}
• {"criterion_text":"- Patient on SGLT2 inhibitors prior to admission to intensive care unit or CCU"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Patients on lithium."}
• {"criterion_text":"- Patient in shock for another cause or moribund (SAPS2> 90)."}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessed at 12 weeks from randomization using the win-ratio method. Rank 1 and Rank 2 are time-to-event measures (time to all-cause death/heart transplant/mechanical ventricular assist; time to rehospitalization for heart failure). Rank 3 is left ventricular ejection fraction measured by echocardiography."}

Secondary endpoints

• {"endpoint_text":"- Death at 12 weeks","definition_or_measurement_approach":"All-cause mortality assessed at 12 weeks."}
• {"endpoint_text":"- Heart transplantation or long-term ventricular assistance at 12 weeks","definition_or_measurement_approach":"Occurrence of heart transplant or long-term ventricular assist device implantation assessed at 12 weeks."}
• {"endpoint_text":"- Rehospitalization for heart failure from hospital discharge to 12-week","definition_or_measurement_approach":"Rehospitalization for heart failure occurring between hospital discharge and 12 weeks."}
• {"endpoint_text":"- Left ventricular ejection fraction at 12 weeks","definition_or_measurement_approach":"Left ventricular ejection fraction measured by echocardiography at 12 weeks."}
• {"endpoint_text":"- Left ventricular relaxation and filling pressures assessed at 12 weeks: e' wave, E/e' ratio,","definition_or_measurement_approach":"Echocardiographic measures of diastolic function (e' wave, E/e' ratio) assessed at 12 weeks."}
• {"endpoint_text":"- Right ventricular function assessed at 12 weeks: TAPSE, S wave","definition_or_measurement_approach":"Right ventricular function assessed by echocardiographic parameters (TAPSE, S wave) at 12 weeks."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Number of patients requiring renal replacement therapy between randomization and 12 weeks; renal function evolution measured by eGFR calculated with CKD-EPI at randomization and 12 weeks."}
• {"endpoint_text":"- Liver function assessed at randomization and at 12 weeks: Bilirubin, Prothrombin Ratio , SGOT, SGPT.","definition_or_measurement_approach":"Biochemical liver function tests (bilirubin, prothrombin ratio, SGOT/ASAT, SGPT/ALAT) measured at randomization and 12 weeks."}
• {"endpoint_text":"- Weight and NT-proBNP (at randomization and at 12 weeks).","definition_or_measurement_approach":"Body weight and NT-proBNP levels measured at randomization and 12 weeks."}

France

Earliest CTIS Part Ii Submission Date

28-02-2024

Latest Decision Or Authorization Date

27-11-2025

Processing Time Days

638

Number Of Sites

8

Number Of Participants

164

Primary sponsor

Full Name

CHRU De Nancy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"French Ministry of Health (PHRC IR 2021)","duties_or_roles":"Monetary support","organisation_type":""}