Ireland
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Starting soon Not applicable

Unloading in Heart Failure Cardiogenic Shock

NCT05064202 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2023-10-01
Last updated
2023-08-01

Condition(s) studied

Cardiogenic Shock

Investigational drug(s) / intervention(s)

Impella 5.5Inotropes

Impella 5.5: temporary Mechanical Circulatory Support (tMCS)

Inotropes: Enoximone, Dobutamine, Dopamine, Milrinone

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint) — baseline to 90 days
    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

Trial sites (5)

FacilityCityRegionStatus
Academical Medical Center (AMC) Amsterdam Netherlands
VU University Medical Center (VUMC) Amsterdam Netherlands
Univerity Medical Center Groningen (UMCG) Groningen Netherlands
Leids Universitair Medisch Centrum (LUMC) Leiden Netherlands
University Medical Center Utrecht (UMCU) Utrecht Netherlands
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05064202 on ClinicalTrials.gov ↗ ← All trials in the Netherlands