NCT05064202Not yet recruiting
Unloading in Heart Failure Cardiogenic Shock
Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.
Source: ClinicalTrials.gov · Last updated 1 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 456 (estimated)
- First submitted
- 26 Aug 2021
- Start date
- 1 Oct 2023
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Heart failure
- NCT number
- NCT05064202
What you commit to
- Study type: Interventional
- Planned participants: 456
- From 1 Oct 2023 to the primary completion date, 1 Oct 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VU University Medical Center (VUmc) Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Academical Medical Center (AMC) Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Univerity Medical Center Groningen (UMCG) Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| University Medical Center Utrecht(UMCU) Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.