Cardiogenic ShockNCT05577195
Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO
A study testing Impella and VA-ECMO in people with Cardiogenic Shock, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Prospective, multi-center, randomized (1:1), controlled trial of Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Impella and VA-ECMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteGermany
- Study dates
- 17 Nov 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe cardiogenic shock due to severe left ventricular dysfunction:
- Systolic blood pressure <90 mmHg or need for catecholamines to maintain such blood pressure
- Signs of impaired organ perfusion with at least one of the following: altered mental status OR cold, clammy skin OR oliguria with urine output <30 ml/h
- Arterial lactate >5 mmol/l
Who cannot join
- Post-cardiotomy cardiogenic shock.
- Cardiogenic shock due to acute rejection in heart transplant recipients.
- Obstructive cardiogenic shock (e.g. cardiogenic shock due to fulminant pulmonary embolism)
- Cardiogenic shock due to other causes (e.g. bleeding, hypothermia)
- Pre-existing Impella treatment.
- Onset of shock >12 hours.
Show all 12Show fewer
- Mechanical complication of acute myocardial infarction.
- Prolonged resuscitation (>60 minutes).
- Severe peripheral artery disease with infeasibility for Impella or veno-arterial extracorporeal membrane oxygenation implantation.
- Age <18 or >80 years.
- Other severe concomitant disease with life expectancy <6 months.
- Participation in another trial with an intervention or pregnancy.
Trial locations and contacts
1 site in 1 country.
Benedikt Schrage, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
University Heart and Vascular Center Hamburg
Hamburg, 20251
Benedikt Schrage, MD, PhD
About this study
Official title: UNLOAD ECMO - Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO - a Prospective, Randomized, Controlled, Multi-center Trial
Prospective, multi-center, randomized (1:1), controlled trial of Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock.
Read the detailed description
In the past years extensive efforts in developing treatment strategies for patients with cardiogenic shock have been performed. One promising such strategy is active unloading of the left ventricle while simultaneously supporting the circulatory system with veno-arterial extracorporeal membrane oxygenation. Recently, in a multinational, multicenter, retrospective registry, it has been shown that this approach might be associated with lower mortality .
The investigators now seek to extend the evidence on this topic and to test this approach in a prospective, randomized, controlled, multicenter trial. A power calculation has been conducted based on the data from the registry. N=198 patients with cardiogenic shock will be randomized 1:1 to be either treated with an Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation or with veno-arterial extracorporeal membrane oxygenation alone. A blinded interim analysis will be performed, which might lead to an adjustment of the enrollment target. The primary endpoint of this study will be death from any cause 30 days after randomization.
- Conditions
- Cardiogenic Shock
- Being tested
- Impella, VA-ECMO
- Keywords
- Active left ventricular unloading, VA-ECMO, Impella, Cardiogenic shock
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImpellaDevice
To provide active left ventricular unloading in the experimental arm
VA-ECMODevice
To provide circulatory support in both arms
| Study group | Role | What they receive |
|---|---|---|
| Impella + VA-ECMO | Experimental | Not described Receives: Device: Impella; Device: VA-ECMO |
| VA-ECMO only | Active comparator | Not described Receives: Device: VA-ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death from any-cause within 30 days after randomization
Time to death from any-cause within 30 days after randomization
Measured: 30 days
Secondary outcomes (10)
Death from any-cause at 6 and 12 months as well as time to death at these time points
Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points
Measured: 6 and 12 months
Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points
Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points
Measured: 30 days, 6 and 12 months
Length of veno-arterial extracorporeal membrane oxygenation therapy, mechanical ventilation, inotrope therapy and stay at the intensive care unit (in days).
Length of veno-arterial extracorporeal membrane oxygenation therapy, mechanical ventilation, inotrope therapy and stay at the intensive care unit (in days).
Measured: 12 months
Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days
Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days
Measured: 30 days
Need for renal replacement therapy until day 30, 6 months and 12 months
Need for renal replacement therapy, intermittent or ongoing, until day 30, 6 months and 12 months
Measured: 30 days, 6 and 12 months
Neurological function (per Cerebral Performance Category) at day 30, 6 months and 12 months
Neurological function (per Cerebral Performance Category) at day 30, 6 months and 12 months
Measured: 30 days, 6 and 12 months
Rate of incidence of hospitalization for heart failure (hospitalization for more than 24 hours with heart failure as the main reason) as well as time to first event after 6 months and 12 months and recurrent events within 12 months
Rate of incidence of hospitalization for heart failure (hospitalization for more than 24 hours with heart failure as the main reason) as well as time to first event after 6 months and 12 months and recurrent events within 12 months
Measured: 6 and 12 months
Left ventricular function assessed by echocardiography at day 30, 6 months and 12 months
Left ventricular function assessed by echocardiography at day 30, 6 months and 12 months
Measured: 30 days, 6 and 12 months
Quality of life as assessed by the "Kansas City Cardiomyopathy Questionnaire" at 30-days and at 12 months
Quality of life as assessed by the "Kansas City Cardiomyopathy Questionnaire" at 30-days and at 12 months
Measured: 30 days and 6 months
6-Minute Walking Distance at day 30, 6 months and 12 months
6-Minute Walking Distance at day 30, 6 months and 12 months
Measured: 30 days, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start17 Nov 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577195
- Sponsor's protocol ID
- UNLOAD ECMO
- Status last verified
- Dec 2022
- First submitted
- 10 Oct 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moussa MD, Roux J, Jungling M, Ramdane N, Loobuyck V, Brassart B, Rousse N, Dupre C, Mugnier A, Khalipha A, Bardeesi ASA, Lukowiak O, Lefebvre L, Juthier F, Robin E, Labreuche J, Thellier L, Vincentelli A. Impella Versus Selective Biatrial Canulation for Left Ventricular Unloading During Extracorporeal Membrane Oxygenation. Cardiovasc Ther. 2026 Feb 8;2026:3669575. doi: 10.1155/cdr/3669575. eCollection 2026.
PubMed 41668891Schrage B, Sundermeyer J, Blankenberg S, Colson P, Eckner D, Eden M, Eitel I, Frank D, Frey N, Graf T, Kirchhof P, Kupka D, Landmesser U, Linke A, Majunke N, Mangner N, Maniuc O, Mierke J, Mobius-Winkler S, Morrow DA, Mourad M, Nordbeck P, Orban M, Pappalardo F, Patel SM, Pauschinger M, Pazzanese V, Radakovic D, Schulze PC, Scherer C, Schwinger RHG, Skurk C, Thiele H, Varshney A, Wechsler L, Westermann D. Timing of Active Left Ventricular Unloading in Patients on Venoarterial Extracorporeal Membrane Oxygenation Therapy. JACC Heart Fail. 2023 Mar;11(3):321-330. doi: 10.1016/j.jchf.2022.11.005. Epub 2023 Jan 11.
PubMed 36724180
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNLOAD ECMO - Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO - a Prospective, Randomized, Controlled, Multi-center Trial
- ClinicalTrials.gov ID
- NCT05577195
- Acronym / sponsor ID
- UNLOAD ECMO
- Conditions
- Cardiogenic Shock
- Keywords
- Active left ventricular unloading, VA-ECMO, Impella, Cardiogenic shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 13 Oct 2022 (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.
Prospective, multi-center, randomized (1:1), controlled trial of Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock.
Detailed description
In the past years extensive efforts in developing treatment strategies for patients with cardiogenic shock have been performed. One promising such strategy is active unloading of the left ventricle while simultaneously supporting the circulatory system with veno-arterial extracorporeal membrane oxygenation. Recently, in a multinational, multicenter, retrospective registry, it has been shown that this approach might be associated with lower mortality .
The investigators now seek to extend the evidence on this topic and to test this approach in a prospective, randomized, controlled, multicenter trial. A power calculation has been conducted based on the data from the registry. N=198 patients with cardiogenic shock will be randomized 1:1 to be either treated with an Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation or with veno-arterial extracorporeal membrane oxygenation alone. A blinded interim analysis will be performed, which might lead to an adjustment of the enrollment target. The primary endpoint of this study will be death from any cause 30 days after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impella + VA-ECMO | Experimental | Device: Impella, Device: VA-ECMO |
| VA-ECMO only | Active comparator | Device: VA-ECMO |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Systolic blood pressure <90 mmHg or need for catecholamines to maintain such blood pressure
- Signs of impaired organ perfusion with at least one of the following: altered mental status OR cold, clammy skin OR oliguria with urine output <30 ml/h
- Arterial lactate >5 mmol/l
Key exclusion criteria (12 listed)
- Post-cardiotomy cardiogenic shock.
- Cardiogenic shock due to acute rejection in heart transplant recipients.
- Obstructive cardiogenic shock (e.g. cardiogenic shock due to fulminant pulmonary embolism)
- Cardiogenic shock due to other causes (e.g. bleeding, hypothermia)
- Pre-existing Impella treatment.
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 |
|---|---|---|
| ImpellaTo provide active left ventricular unloading in the experimental arm | Device | Impella + VA-ECMO |
| VA-ECMOTo provide circulatory support in both arms | Device | Impella + VA-ECMO, VA-ECMO only |
Primary outcome
Time to death from any-cause within 30 days after randomization
Time frame: 30 days
Time to death from any-cause within 30 days after randomization
10 secondary outcomes
Death from any-cause at 6 and 12 months as well as time to death at these time points
Time frame: 6 and 12 months
Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points
Time frame: 30 days, 6 and 12 months
Length of veno-arterial extracorporeal membrane oxygenation therapy, mechanical ventilation, inotrope therapy and stay at the intensive care unit (in days).
Time frame: 12 months
Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days
Time frame: 30 days
Need for renal replacement therapy until day 30, 6 months and 12 months
Time frame: 30 days, 6 and 12 months
Neurological function (per Cerebral Performance Category) at day 30, 6 months and 12 months
Time frame: 30 days, 6 and 12 months
Rate of incidence of hospitalization for heart failure (hospitalization for more than 24 hours with heart failure as the main reason) as well as time to first event after 6 months and 12 months and recurrent events within 12 months
Time frame: 6 and 12 months
Left ventricular function assessed by echocardiography at day 30, 6 months and 12 months
Time frame: 30 days, 6 and 12 months
Quality of life as assessed by the "Kansas City Cardiomyopathy Questionnaire" at 30-days and at 12 months
Time frame: 30 days and 6 months
6-Minute Walking Distance at day 30, 6 months and 12 months
Time frame: 30 days, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Derived from this study: PubMed 41668891Moussa MD, Roux J, Jungling M, Ramdane N, Loobuyck V, Brassart B, Rousse N, Dupre C, Mugnier A, Khalipha A, Bardeesi ASA, Lukowiak O, Lefebvre L, Juthier F, Robin E, Labreuche J, Thellier L, Vincentelli A. Impella Versus Selective Biatrial Canulation for Left Ventricular Unloading During Extracorporeal Membrane Oxygenation. Cardiovasc Ther. 2026 Feb 8;2026:3669575. doi: 10.1155/cdr/3669575. eCollection 2026.
- Derived from this study: PubMed 36724180Schrage B, Sundermeyer J, Blankenberg S, Colson P, Eckner D, Eden M, Eitel I, Frank D, Frey N, Graf T, Kirchhof P, Kupka D, Landmesser U, Linke A, Majunke N, Mangner N, Maniuc O, Mierke J, Mobius-Winkler S, Morrow DA, Mourad M, Nordbeck P, Orban M, Pappalardo F, Patel SM, Pauschinger M, Pazzanese V, Radakovic D, Schulze PC, Scherer C, Schwinger RHG, Skurk C, Thiele H, Varshney A, Wechsler L, Westermann D. Timing of Active Left Ventricular Unloading in Patients on Venoarterial Extracorporeal Membrane Oxygenation Therapy. JACC Heart Fail. 2023 Mar;11(3):321-330. doi: 10.1016/j.jchf.2022.11.005. Epub 2023 Jan 11.
- 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. This study is not recruiting at the moment.
Benedikt Schrage, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impella and VA-ECMO in people with Cardiogenic Shock, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk Westermann, Prof. (0049 40 7410 0, d.westermann@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to death from any-cause within 30 days after randomization (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05577195, which also lists 2 linked publications.
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 29 Dec 2022.