Cardiogenic Shock
Conditions
Keywords
Unloading, Acute Decompensated Heart Failure, Cardiogenic Shock, temporary Mechanical Circulatory Support (tMCS), Inotropes
Brief 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.
Detailed description
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
Interventions
DEVICEImpella 5.5
temporary Mechanical Circulatory Support (tMCS)
DRUGInotropes
Enoximone, Dobutamine, Dopamine, Milrinone
Sponsors
Abiomed Inc.
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality (Efficacy - Secondary Endpoint) | baseline to 28 days | Number of patients suffering from cardiac death and non-cardiac death and undetermined death during hospitalisation |
| In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint) | baseline to 28 days | Number of patients with progression to SCAI CS stage D OR E (depending on stage directly after randomization) |
| Cardiac mortality (Efficacy - Secondary Endpoint) | baseline to 1 year | Number of patients that died of any cause at 90 days and 1 year |
| All-cause mortality (Efficacy - Secondary Endpoint) | baseline to 1 year | Number of patients that died of any cause at 90 days and 1 year |
| Mechanical ventillation (Efficacy - Secondary Endpoint) | baseline to 1 year | Number of patients that were mechanically ventilated during hospitalization, up to day 90 and 1 year |
| Renal replacement therapy (Efficacy - Secondary Endpoint) | baseline to 1 year | Number of patients that received renal replacement therapy during hospitalization, up to day 90 and 1 year |
| Hospitalization or urgent hospital visit for heart failure (Efficacy - Secondary Endpoint) | baseline to 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 |
| Urgent / rescue MCS implantation (permanent) (Efficacy - Secondary Endpoint) | baseline to 1 year | Number of patients that received a permanent MCS device implantation up to day 90 and 1 year |
| Hospitalization time (Efficacy - Secondary Endpoint) | baseline to 28 days | Lenght of index hospitalization for HF-CS in days |
| LVAD / Heart transplantation (Efficacy - Secondary Endpoint) | baseline to 1 year | Number of patients that received heart treplacement therapy up to discharge, 90 days and 1 year |
| KCCQ-12 (Efficacy - Secondary Endpoint) | 90 days, 1 year | Average KCCQ-12 at 90 days and 1 year |
| Stroke or TIA (Safety - Secondary Endpoint) | baseline to 28 days | Number of patients that developed a stroke or TIA up to discharge |
| Major Bleeding (Safety - Secondary Endpoint) | baseline to 28 days | Number of patients that developed a major bleed up to discharge |
| Major vascular events (Safety - Secondary Endpoint) | baseline to 28 days | Number of patients that developed a major vascular event up to discharge |
| Extremity ischemia (Safety - Secondary Endpoint) | baseline to 28 days | Number of patients that developed limb ischemia up to discharge |
| Hemolysis (Safety - Secondary Endpoint) | baseline to 28 days | Number of patients diagnosed with hemolysis up to discharge |
| Insertion site infection (Safety - Secondary Endpoint) | baseline to 28 days | Number of patients that developed an infection at the insertion site up to discharge |
| Aortic valve injury (Safety - Secondary Endpoint) | baseline to 90 days | Number of patients that developed aortic valve insufficiency (by echo) up to day 90 |
| Vasoactive Inotropic Score (maximal) (Efficacy - Secondary Endpoint) | baseline to 28 days | Maximal VIS during hospitalization |
Countries
Netherlands
Contacts
Primary ContactAlexander Nap, MD PhD
Outcome results
None listed