Tests Impella 5.5 heart pump support in heart failure with cardiogenic shock
Tests a heart pump against usual care in adults with heart failure and shock.
Plain-language title generated from the registry record
Registry title: Unloading in Heart Failure Cardiogenic Shock
Key facts
- Where
- Amsterdam, Groningen, Leiden, and Utrecht, NetherlandsSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05064202, who can take part
Where in Netherlands
- Academical Medical Center (AMC)Amsterdam, NetherlandsNo longer taking part
- VU University Medical Center (VUmc)Amsterdam, NetherlandsNo longer taking part
- Univerity Medical Center Groningen (UMCG)Groningen, NetherlandsNo longer taking part
- Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsNo longer taking part
- University Medical Center Utrecht(UMCU)Utrecht, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC, location VUmc
- Trial code
- NCT05064202
- Record updated
- 1 August 2023
- Original description
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.Read full original descriptionShow less
Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.
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.
Inclusion: 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: Severe concomitant RV failure; Grade IV mitral regurgitation eligible for surgical treatment; History of CVA or TIA within previous 90 days; History of acute myocardial infarction within previous 30 days; Dialysis for end-stage renal failure; Acute coronary syndrome (type 1, AMI); Combined cardiorespiratory failure; History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions; Active systemic infections; Contraindications for Impella 5.5; Bradycardia and AV blocks necessitating pacemaker implantation; HD parameters and biochemistry alterations as specifically defined for SCAI CS E; Resuscitated (OHCA/PEA); Inflammatory; Acute myocarditis.