Clinical trial NCT05064202: Unloading in Heart Failure Cardiogenic Shock
Official title: Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiogenic Shock
Keywords: Unloading
Acute Decompensated Heart Failure
Cardiogenic Shock
temporary Mechanical Circulatory Support (tMCS)
Inotropes
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Abiomed Inc.
First posted: 2021-10-01
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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 outcomes:
measure: Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint)
timeFrame: baseline to 90 days
Secondary outcomes:
measure: In-hospital mortality (Efficacy - Secondary Endpoint)
timeFrame: baseline to 28 days
measure: In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint)
timeFrame: baseline to 28 days
measure: Cardiac mortality (Efficacy - Secondary Endpoint)
timeFrame: baseline to 1 year
measure: All-cause mortality (Efficacy - Secondary Endpoint)
timeFrame: baseline to 1 year
measure: Mechanical ventillation (Efficacy - Secondary Endpoint)
timeFrame: baseline to 1 year
measure: Renal replacement therapy (Efficacy - Secondary Endpoint)
timeFrame: baseline to 1 year
measure: Hospitalization or urgent hospital visit for heart failure (Efficacy - Secondary Endpoint)
timeFrame: baseline to 1 year
measure: Urgent / rescue MCS implantation (permanent) (Efficacy - Secondary Endpoint)
timeFrame: baseline to 1 year
measure: Hospitalization time (Efficacy - Secondary Endpoint)
timeFrame: baseline to 28 days
measure: Vasoactive Inotropic Score (maximal) (Efficacy - Secondary Endpoint)
timeFrame: baseline to 28 days
measure: LVAD / Heart transplantation (Efficacy - Secondary Endpoint)
timeFrame: baseline to 1 year
measure: KCCQ-12 (Efficacy - Secondary Endpoint)
timeFrame: 90 days, 1 year
measure: Stroke or TIA (Safety - Secondary Endpoint)
timeFrame: baseline to 28 days
measure: Major Bleeding (Safety - Secondary Endpoint)
timeFrame: baseline to 28 days
measure: Major vascular events (Safety - Secondary Endpoint)
timeFrame: baseline to 28 days
measure: Extremity ischemia (Safety - Secondary Endpoint)
timeFrame: baseline to 28 days
measure: Hemolysis (Safety - Secondary Endpoint)
timeFrame: baseline to 28 days
measure: Insertion site infection (Safety - Secondary Endpoint)
timeFrame: baseline to 28 days
measure: Aortic valve injury (Safety - Secondary Endpoint)
timeFrame: baseline to 90 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academical Medical Center (AMC)
city: Amsterdam
country: Netherlands
facility: VU University Medical Center (VUMC)
city: Groningen
country: Netherlands
facility: Univerity Medical Center Groningen (UMCG)
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC)
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht (UMCU)
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Alexander Nap, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: