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| Name | Class |
|---|---|
| Abiomed Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Impella 5.5 | Experimental | ADHF-CS patients who are in the experimental arm will be treated with an Impella 5.5 (+/- standard of care) |
|
| Standard of care | Other | ADHF-CS patients who are in the control arm will be treated with escalating doses of inotropes (standard of care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impella 5.5 | Device | temporary Mechanical Circulatory Support (tMCS) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality (Efficacy - Secondary Endpoint) | Number of patients suffering from cardiac death and non-cardiac death and undetermined death during hospitalisation | baseline to 28 days |
| In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint) |
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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
Hypoperfusion
Inotropes/vasoactives (use of)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Nap, MD PhD | Contact | +31(0)614102081 | a.nap@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Nap, MD PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academical Medical Center (AMC) | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Inotropes |
| Drug |
Enoximone, Dobutamine, Dopamine, Milrinone |
|
Number of patients with progression to SCAI CS stage D OR E (depending on stage directly after randomization) |
| baseline to 28 days |
| Cardiac mortality (Efficacy - Secondary Endpoint) | Number of patients that died of any cause at 90 days and 1 year | baseline to 1 year |
| All-cause mortality (Efficacy - Secondary Endpoint) | Number of patients that died of any cause at 90 days and 1 year | baseline to 1 year |
| Mechanical ventillation (Efficacy - Secondary Endpoint) | Number of patients that were mechanically ventilated during hospitalization, up to day 90 and 1 year | baseline to 1 year |
| Renal replacement therapy (Efficacy - Secondary Endpoint) | Number of patients that received renal replacement therapy during hospitalization, up to day 90 and 1 year | baseline to 1 year |
| Hospitalization or urgent hospital visit for heart failure (Efficacy - Secondary Endpoint) | Number of patients that were hospitalized or had an urgent hospital visit for heart failure up to day 30, 60 and 1 year | baseline to 1 year |
| Urgent / rescue MCS implantation (permanent) (Efficacy - Secondary Endpoint) | Number of patients that received a permanent MCS device implantation up to day 90 and 1 year | baseline to 1 year |
| Hospitalization time (Efficacy - Secondary Endpoint) | Lenght of index hospitalization for HF-CS in days | baseline to 28 days |
| Vasoactive Inotropic Score (maximal) (Efficacy - Secondary Endpoint) | Maximal VIS during hospitalization | baseline to 28 days |
| LVAD / Heart transplantation (Efficacy - Secondary Endpoint) | Number of patients that received heart treplacement therapy up to discharge, 90 days and 1 year | baseline to 1 year |
| KCCQ-12 (Efficacy - Secondary Endpoint) | Average KCCQ-12 at 90 days and 1 year | 90 days, 1 year |
| Stroke or TIA (Safety - Secondary Endpoint) | Number of patients that developed a stroke or TIA up to discharge | baseline to 28 days |
| Major Bleeding (Safety - Secondary Endpoint) | Number of patients that developed a major bleed up to discharge | baseline to 28 days |
| Major vascular events (Safety - Secondary Endpoint) | Number of patients that developed a major vascular event up to discharge | baseline to 28 days |
| Extremity ischemia (Safety - Secondary Endpoint) | Number of patients that developed limb ischemia up to discharge | baseline to 28 days |
| Hemolysis (Safety - Secondary Endpoint) | Number of patients diagnosed with hemolysis up to discharge | baseline to 28 days |
| Insertion site infection (Safety - Secondary Endpoint) | Number of patients that developed an infection at the insertion site up to discharge | baseline to 28 days |
| Aortic valve injury (Safety - Secondary Endpoint) | Number of patients that developed aortic valve insufficiency (by echo) up to day 90 | baseline to 90 days |
| 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 |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |