Effect of early use of levosimendan versus placebo on top of a conventional strategy of inotrope use on a combined morbidity-mortality endpoint in patients with cardiogenic shock. LevoHeartShock

Cardiogenic Shock

All-cause mortality and/or ECLS and/or dialysis at day 30 following randomization.

Prioritized composite endpoint at days 90 with the following priority order: 1/ time to death, 2/ escalation to permanent left ventricular assist device or cardiac transplantation, 3/ dialysis, 4/ ECLS requirement, 5/ number of cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure)., Major adverse cardiovascular events: death, ECLS requirement, dialysis, cardiac transplantation, escalation to permanent left ventricular assist device, major cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure) on days 90, Composite endpoint of all-cause mortality and/or ECLS requirement and/or dialysis on day 90;, Number of dobutamine free days between randomization and D30, Number of vasopressors free days between randomization and D30;, Number of ventilatory free days between randomization and D30, Number of renal replacement free days between randomization and D 90, Lactate clearance from randomization to D7, Duration of ICU stay and hospitalization, Composite endpoint of all-cause mortality and/or ECLS requirement and/or dialysis on days 7, 60, and 180 days and 12 months following randomization, Number of renal replacement free days between randomization and D 30, 60, 180 and at 12 months, Major adverse cardiovascular events: death, ECLS requirement, dialysis, cardiac transplantation, escalation to permanent left ventricular assist device, major cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure) on days 180 and at 12 months;, Occurrence of arrhythmias requiring therapy with anti-arrhythmic drugs or electric cardioversion (including atrial fibrillation, ventricular tachycardia, ventricular fibrillation, torsade de pointe) from randomization to ICU or CCU discharge., Changes in biomarkers between randomization and ICU/CCU discharge, For objectives B2 and B3 the primary outcome will be considered

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