Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Impella 5.5
- Conditions
- Cardiogenic Shock
- Sponsor
- Amsterdam UMC, location VUmc
- Enrollment
- 456
- Locations
- 5
- Primary Endpoint
- Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Alexander Nap
Principal Investigator
Amsterdam UMC, location VUmc
Eligibility Criteria
Inclusion Criteria
- •Evidence of HFrEF according to ESC HF guidelines (LVEF ≤ 35%)
- •Signs of (persistent) congestion (elevated CVP, edema, rales, ascites, pleural effusion)
- •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)
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
Arms & Interventions
Impella 5.5
ADHF-CS patients who are in the experimental arm will be treated with an Impella 5.5 (+/- standard of care)
Intervention: 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)
Intervention: Inotropes
Outcomes
Primary Outcomes
Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint)
Time Frame: 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 Outcomes
- Hospitalization or urgent hospital visit for heart failure (Efficacy - Secondary Endpoint)(baseline to 1 year)
- In-hospital mortality (Efficacy - Secondary Endpoint)(baseline to 28 days)
- In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint)(baseline to 28 days)
- Vasoactive Inotropic Score (maximal) (Efficacy - Secondary Endpoint)(baseline to 28 days)
- KCCQ-12 (Efficacy - Secondary Endpoint)(90 days, 1 year)
- Major vascular events (Safety - Secondary Endpoint)(baseline to 28 days)
- Aortic valve injury (Safety - Secondary Endpoint)(baseline to 90 days)
- All-cause mortality (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Mechanical ventillation (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Cardiac mortality (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Renal replacement therapy (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Urgent / rescue MCS implantation (permanent) (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Hospitalization time (Efficacy - Secondary Endpoint)(baseline to 28 days)
- LVAD / Heart transplantation (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Stroke or TIA (Safety - Secondary Endpoint)(baseline to 28 days)
- Major Bleeding (Safety - Secondary Endpoint)(baseline to 28 days)
- Extremity ischemia (Safety - Secondary Endpoint)(baseline to 28 days)
- Hemolysis (Safety - Secondary Endpoint)(baseline to 28 days)
- Insertion site infection (Safety - Secondary Endpoint)(baseline to 28 days)