Unloading in Heart Failure Cardiogenic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Impella 5.5, Inotropes.
- Who it may be relevant to
- Registry conditions: Cardiogenic Shock. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.
Overview
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
- Device Impella 5.5
temporary Mechanical Circulatory Support (tMCS) - Drug Inotropes
Enoximone, Dobutamine, Dopamine, Milrinone
Primary outcome measures
- 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]
Secondary outcome measures (12)
- In-hospital mortality (Efficacy - Secondary Endpoint) [Time frame: baseline to 28 days]
- In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint) [Time frame: baseline to 28 days]
- Cardiac mortality (Efficacy - Secondary Endpoint) [Time frame: baseline to 1 year]
- All-cause mortality (Efficacy - Secondary Endpoint) [Time frame: baseline to 1 year]
- Mechanical ventillation (Efficacy - Secondary Endpoint) [Time frame: baseline to 1 year]
- Renal replacement therapy (Efficacy - Secondary Endpoint) [Time frame: baseline to 1 year]
- Hospitalization or urgent hospital visit for heart failure (Efficacy - Secondary Endpoint) [Time frame: baseline to 1 year]
- Urgent / rescue MCS implantation (permanent) (Efficacy - Secondary Endpoint) [Time frame: baseline to 1 year]
- Hospitalization time (Efficacy - Secondary Endpoint) [Time frame: baseline to 28 days]
- Vasoactive Inotropic Score (maximal) (Efficacy - Secondary Endpoint) [Time frame: baseline to 28 days]
- LVAD / Heart transplantation (Efficacy - Secondary Endpoint) [Time frame: baseline to 1 year]
- KCCQ-12 (Efficacy - Secondary Endpoint) [Time frame: 90 days, 1 year]
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:
- 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)
- oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h)
- Inotropes/vasoactives (use of)
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
- History of acute myocardial infarction within previous 30 days
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions
- Inflammatory
- Active systemic infections
- Acute myocarditis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 5 centers
- Academical Medical Center (AMC) — Amsterdam
- VU University Medical Center (VUMC) — Amsterdam
- Univerity Medical Center Groningen (UMCG) — Groningen
- Leids Universitair Medisch Centrum (LUMC) — Leiden
- University Medical Center Utrecht (UMCU) — Utrecht
Identifiers
NCT: NCT05064202 · NL84199.018.23