Unloading in Heart Failure Cardiogenic Shock (UNLOAD HF-CS)

July 29, 2023 updated by: Alexander Nap, Amsterdam UMC, location VUmc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
456

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Academical Medical Center (AMC)
        • Contact:
          • Jose PS Henriques, MD PhD
      • Amsterdam, Netherlands
        • VU University Medical Center (VUMC)
        • Contact:
          • Alexander Nap, MD PhD
      • Groningen, Netherlands
        • Univerity Medical Center Groningen (UMCG)
        • Contact:
          • Kevin Damman, MD PhD
      • Leiden, Netherlands
        • Leids Universitair Medisch Centrum (LUMC)
        • Contact:
          • Jose Montero-Cabezas, MD PhD
      • Utrecht, Netherlands
        • University Medical Center Utrecht (UMCU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Impella 5.5
ADHF-CS patients who are in the experimental arm will be treated with an Impella 5.5 (+/- standard of care)
Device: Impella 5.5
temporary Mechanical Circulatory Support (tMCS)
Other: Standard of care
ADHF-CS patients who are in the control arm will be treated with escalating doses of inotropes (standard of care)
Drug: Inotropes
Enoximone, Dobutamine, Dopamine, Milrinone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline to 90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-hospital mortality (Efficacy - Secondary Endpoint)
Time Frame: baseline to 28 days
Number of patients suffering from cardiac death and non-cardiac death and undetermined death during hospitalisation
baseline to 28 days
In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint)
Time Frame: baseline to 28 days
Number of patients with progression to SCAI CS stage D OR E (depending on stage directly after randomization)
baseline to 28 days
Cardiac mortality (Efficacy - Secondary Endpoint)
Time Frame: baseline to 1 year
Number of patients that died of any cause at 90 days and 1 year
baseline to 1 year
All-cause mortality (Efficacy - Secondary Endpoint)
Time Frame: baseline to 1 year
Number of patients that died of any cause at 90 days and 1 year
baseline to 1 year
Mechanical ventillation (Efficacy - Secondary Endpoint)
Time Frame: baseline to 1 year
Number of patients that were mechanically ventilated during hospitalization, up to day 90 and 1 year
baseline to 1 year
Renal replacement therapy (Efficacy - Secondary Endpoint)
Time Frame: baseline to 1 year
Number of patients that received renal replacement therapy during hospitalization, up to day 90 and 1 year
baseline to 1 year
Hospitalization or urgent hospital visit for heart failure (Efficacy - Secondary Endpoint)
Time Frame: baseline to 1 year
Number of patients that were hospitalized or had an urgent hospital visit for heart failure up to day 30, 60 and 1 year
baseline to 1 year
Urgent / rescue MCS implantation (permanent) (Efficacy - Secondary Endpoint)
Time Frame: baseline to 1 year
Number of patients that received a permanent MCS device implantation up to day 90 and 1 year
baseline to 1 year
Hospitalization time (Efficacy - Secondary Endpoint)
Time Frame: baseline to 28 days
Lenght of index hospitalization for HF-CS in days
baseline to 28 days
Vasoactive Inotropic Score (maximal) (Efficacy - Secondary Endpoint)
Time Frame: baseline to 28 days
Maximal VIS during hospitalization
baseline to 28 days
LVAD / Heart transplantation (Efficacy - Secondary Endpoint)
Time Frame: baseline to 1 year
Number of patients that received heart treplacement therapy up to discharge, 90 days and 1 year
baseline to 1 year
KCCQ-12 (Efficacy - Secondary Endpoint)
Time Frame: 90 days, 1 year
Average KCCQ-12 at 90 days and 1 year
90 days, 1 year
Stroke or TIA (Safety - Secondary Endpoint)
Time Frame: baseline to 28 days
Number of patients that developed a stroke or TIA up to discharge
baseline to 28 days
Major Bleeding (Safety - Secondary Endpoint)
Time Frame: baseline to 28 days
Number of patients that developed a major bleed up to discharge
baseline to 28 days
Major vascular events (Safety - Secondary Endpoint)
Time Frame: baseline to 28 days
Number of patients that developed a major vascular event up to discharge
baseline to 28 days
Extremity ischemia (Safety - Secondary Endpoint)
Time Frame: baseline to 28 days
Number of patients that developed limb ischemia up to discharge
baseline to 28 days
Hemolysis (Safety - Secondary Endpoint)
Time Frame: baseline to 28 days
Number of patients diagnosed with hemolysis up to discharge
baseline to 28 days
Insertion site infection (Safety - Secondary Endpoint)
Time Frame: baseline to 28 days
Number of patients that developed an infection at the insertion site up to discharge
baseline to 28 days
Aortic valve injury (Safety - Secondary Endpoint)
Time Frame: baseline to 90 days
Number of patients that developed aortic valve insufficiency (by echo) up to day 90
baseline to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amsterdam UMC, location VUmc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abiomed Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexander Nap, MD PhD, Amsterdam Umc, Location Vumc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL84199.018.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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