Unloading in Heart Failure Cardiogenic Shock (UNLOAD HF-CS)

Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.

The purpose of this research study is to evaluate whether timely and aggressive temporary Mechanical Circulatory Support (tMCS) through the Impella 5.5® in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) has the potential to reduce the HF-CS related clinical events compared to the current standard of care.

To demonstrate the efficacy of timely temporary mechanical left ventricular unloading with the Impella 5.5® assist device in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) vs. current standard of (pharmacological) care

Unloading, Acute Decompensated Heart Failure, Cardiogenic Shock, temporary Mechanical Circulatory Support (tMCS), Inotropes

ADHF-CS patients who are in the experimental arm will be treated with an Impella 5.5 (+/- standard of care)

ADHF-CS patients who are in the control arm will be treated with escalating doses of inotropes (standard of care)

Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint)

Number of patients suffering from any of: all-cause death, renal replacement therapy and rehospitalization or urgent hospital visit for heart failure up to 90 days

Number of patients suffering from cardiac death and non-cardiac death and undetermined death during hospitalisation

Number of patients with progression to SCAI CS stage D OR E (depending on stage directly after randomization)

Number of patients that received renal replacement therapy during hospitalization, up to day 90 and 1 year

Number of patients that were hospitalized or had an urgent hospital visit for heart failure up to day 30, 60 and 1 year

Inclusion Criteria: 1. Evidence of HFrEF according to ESC HF guidelines (LVEF ≤ 35%) 2. Signs of (persistent) congestion (elevated CVP, edema, rales, ascites, pleural effusion) 3. Evidence of CS with presence of at least 2 of the 3 following: Hypotension systolic blood pressure <90 mmHg for at least 30 min OR mean arterial pressure <60 mmHg for at least 30 min Hypoperfusion lactate > 2.0 mmol/L (two consecutive values > 2 mmol/L with at least 30 min between samples, with non-decreasing trend on if on (steady doses of) inotropes and/or vasopressors) amino-L-transferase >200 U/L (two consecutive values > 200 Ul/L with at least 30 min between samples, with non-decreasing trend if on (steady doses of) inotropes and/or vasopressors) creatinine rise ≥ 0.3 mg/dl/24h ( 26,53 μmol/L) oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h) Inotropes/vasoactives (use of) Exclusion Criteria: Contraindications for Impella 5.5 Severe concomitant RV failure Grade IV mitral regurgitation eligible for surgical treatment Dialysis for end-stage renal failure Acute coronary syndrome (type 1, AMI) Bradycardia and AV blocks necessitating pacemaker implantation HD parameters and biochemistry alterations as specifically defined for SCAI CS E Combined cardiorespiratory failure Resuscitated (OHCA/PEA) History of CVA or TIA within previous 90 days History of acute myocardial infarction within previous 30 days History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions Inflammatory Active systemic infections Acute myocarditis