Cardiogenic ShockUNLOAD HF-CSNCT05064202
Unloading in Heart Failure Cardiogenic Shock
A study testing Impella 5.5 and Inotropes in people with Cardiogenic Shock, run by Amsterdam UMC, location VUmc at 5 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Impella 5.5 and Inotropes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 5 sitesNetherlands
- Study dates
- 1 Oct 2023to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Netherlands5 sites
Academical Medical Center (AMC)
Amsterdam
Jose PS Henriques, MD PhD
VU University Medical Center (VUMC)
Amsterdam
Alexander Nap, MD PhD
Univerity Medical Center Groningen (UMCG)
Groningen
Kevin Damman, MD PhD
Leids Universitair Medisch Centrum (LUMC)
Leiden
Jose Montero-Cabezas, MD PhD
University Medical Center Utrecht (UMCU)
Utrecht
About this study
Official title: 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.
Read the 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
- Conditions
- Cardiogenic Shock
- Being tested
- Impella 5.5, Inotropes
- Keywords
- Unloading, Acute Decompensated Heart Failure, Cardiogenic Shock, temporary Mechanical Circulatory Support (tMCS), Inotropes
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella 5.5Device
temporary Mechanical Circulatory Support (tMCS)
InotropesDrug
Enoximone, Dobutamine, Dopamine, Milrinone
| Study group | Role | What they receive |
|---|---|---|
| Impella 5.5 | Experimental | ADHF-CS patients who are in the experimental arm will be treated with an Impella 5.5 (+/- standard of care) Receives: Device: Impella 5.5 |
| Standard of care | Other | ADHF-CS patients who are in the control arm will be treated with escalating doses of inotropes (standard of care) Receives: Drug: Inotropes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint)
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
Measured: baseline to 90 days
Secondary outcomes (19)
In-hospital mortality (Efficacy - Secondary Endpoint)
Number of patients suffering from cardiac death and non-cardiac death and undetermined death during hospitalisation
Measured: baseline to 28 days
In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint)
Number of patients with progression to SCAI CS stage D OR E (depending on stage directly after randomization)
Measured: baseline to 28 days
Cardiac mortality (Efficacy - Secondary Endpoint)
Number of patients that died of any cause at 90 days and 1 year
Measured: baseline to 1 year
All-cause mortality (Efficacy - Secondary Endpoint)
Number of patients that died of any cause at 90 days and 1 year
Measured: baseline to 1 year
Mechanical ventillation (Efficacy - Secondary Endpoint)
Number of patients that were mechanically ventilated during hospitalization, up to day 90 and 1 year
Measured: baseline to 1 year
Renal replacement therapy (Efficacy - Secondary Endpoint)
Number of patients that received renal replacement therapy during hospitalization, up to day 90 and 1 year
Measured: baseline to 1 year
Hospitalization or urgent hospital visit for heart failure (Efficacy - Secondary Endpoint)
Number of patients that were hospitalized or had an urgent hospital visit for heart failure up to day 30, 60 and 1 year
Measured: baseline to 1 year
Urgent / rescue MCS implantation (permanent) (Efficacy - Secondary Endpoint)
Number of patients that received a permanent MCS device implantation up to day 90 and 1 year
Measured: baseline to 1 year
Hospitalization time (Efficacy - Secondary Endpoint)
Lenght of index hospitalization for HF-CS in days
Measured: baseline to 28 days
Vasoactive Inotropic Score (maximal) (Efficacy - Secondary Endpoint)
Maximal VIS during hospitalization
Measured: baseline to 28 days
LVAD / Heart transplantation (Efficacy - Secondary Endpoint)
Number of patients that received heart treplacement therapy up to discharge, 90 days and 1 year
Measured: baseline to 1 year
KCCQ-12 (Efficacy - Secondary Endpoint)
Average KCCQ-12 at 90 days and 1 year
Measured: 90 days, 1 year
Stroke or TIA (Safety - Secondary Endpoint)
Number of patients that developed a stroke or TIA up to discharge
Measured: baseline to 28 days
Major Bleeding (Safety - Secondary Endpoint)
Number of patients that developed a major bleed up to discharge
Measured: baseline to 28 days
Major vascular events (Safety - Secondary Endpoint)
Number of patients that developed a major vascular event up to discharge
Measured: baseline to 28 days
Extremity ischemia (Safety - Secondary Endpoint)
Number of patients that developed limb ischemia up to discharge
Measured: baseline to 28 days
Hemolysis (Safety - Secondary Endpoint)
Number of patients diagnosed with hemolysis up to discharge
Measured: baseline to 28 days
Insertion site infection (Safety - Secondary Endpoint)
Number of patients that developed an infection at the insertion site up to discharge
Measured: baseline to 28 days
Aortic valve injury (Safety - Secondary Endpoint)
Number of patients that developed aortic valve insufficiency (by echo) up to day 90
Measured: baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Abiomed Inc.
- Responsible party
- Principal investigator, Alexander Nap, Amsterdam UMC, location VUmc
- Investigators
- Alexander Nap, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064202
- Sponsor's protocol ID
- NL84199.018.23
- Acronym
- UNLOAD HF-CS
- Status last verified
- Jul 2023
- First submitted
- 26 Aug 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.
- ClinicalTrials.gov ID
- NCT05064202
- Acronym / sponsor ID
- UNLOAD HF-CS / NL84199.018.23
- Conditions
- Cardiogenic Shock
- Keywords
- Unloading, Acute Decompensated Heart Failure, Cardiogenic Shock, temporary Mechanical Circulatory Support (tMCS), Inotropes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Abiomed Inc.
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impella 5.5 | Experimental | Device: Impella 5.5ADHF-CS patients who are in the experimental arm will be treated with an Impella 5.5 (+/- standard of care) |
| Standard of care | Other | Drug: InotropesADHF-CS patients who are in the control arm will be treated with escalating doses of inotropes (standard of care) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Hypoperfusion
- Inotropes/vasoactives (use of)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impella 5.5temporary Mechanical Circulatory Support (tMCS) | Device | Impella 5.5 |
| InotropesEnoximone, Dobutamine, Dopamine, Milrinone | Drug | Standard of care |
Primary outcome
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
19 secondary outcomes
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
Stroke or TIA (Safety - Secondary Endpoint)
Time frame: baseline to 28 days
Major Bleeding (Safety - Secondary Endpoint)
Time frame: baseline to 28 days
Major vascular events (Safety - Secondary Endpoint)
Time frame: baseline to 28 days
Extremity ischemia (Safety - Secondary Endpoint)
Time frame: baseline to 28 days
Hemolysis (Safety - Secondary Endpoint)
Time frame: baseline to 28 days
Insertion site infection (Safety - Secondary Endpoint)
Time frame: baseline to 28 days
Aortic valve injury (Safety - Secondary Endpoint)
Time frame: baseline to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Nap, MD PhD principal investigator
Amsterdam UMC, location VUmc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impella 5.5 and Inotropes in people with Cardiogenic Shock, run by Amsterdam UMC, location VUmc at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Nap, MD PhD (+31(0)614102081, a.nap@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.