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

NL84199.018.23

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.

2023-10-01

2027-10-01

2028-07-01

Not yet recruiting

456

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: 1. Hypotension 1. systolic blood pressure \<90 mmHg for at least 30 min OR 2. mean arterial pressure \<60 mmHg for at least 30 min 2. Hypoperfusion 1. 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) 2. 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) 3. creatinine rise ≥ 0.3 mg/dl/24h ( 26,53 μmol/L) 4. oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h) 3. Inotropes/vasoactives (use of) Exclusion Criteria: 1. Contraindications for Impella 5.5 2. Severe concomitant RV failure 3. Grade IV mitral regurgitation eligible for surgical treatment 4. Dialysis for end-stage renal failure 5. Acute coronary syndrome (type 1, AMI) 6. Bradycardia and AV blocks necessitating pacemaker implantation 7. HD parameters and biochemistry alterations as specifically defined for SCAI CS E 8. Combined cardiorespiratory failure 9. Resuscitated (OHCA/PEA) 10. History of CVA or TIA within previous 90 days 11. History of acute myocardial infarction within previous 30 days 12. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions 13. Inflammatory 14. Active systemic infections 15. Acute myocarditis

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 456, 'type': 'ESTIMATED'}}

2023-08-01