Cardiogenic ShockPhase 2NCT06336655
Physiology of Unloading VA ECMO Trial
A Phase 2 study testing IABP in people with Cardiogenic Shock, run by University of Utah at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for cardiogenic shock (CS). The main aims of the study are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- IABP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to 1 Feb 2029
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age 18 years or older)
- Diagnosis of acute cardiogenic shock (CS)
- Patients failing medical therapy, defined as 1 or more of the following:
- Society for Coronary Angiography and Interventions (SCAI) Stage C or greater
- 2 or more inotropic medications and not improving
- IABP in place and clinically worsening
- Placed on VA ECMO for CS
- In the opinion of the attending physician, patient has worsening CS and could require VA ECMO support in the near-term
Who cannot join
- Metastatic or stage 4 cancer
- Atrial septostomy
- Planned LV unloading on ECMO
- Anticipated death <72 hours
- Existing durable left ventricular assist device (dLVAD)
- Unwillingness to randomize
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Joseph E. Tonna, MD, FAAEM, 801.587.9373, joseph.tonna@hsc.utah.edu
About this study
The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for cardiogenic shock (CS). The main aims of the study are:
- To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO
- To determine the effects on myocardial function of adding LV unloading to ECMO
- To test the effects on myocardial recovery of adding LV unloading to VA ECMO
Participants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups.
Read the detailed description
Although extracorporeal membrane oxygenation (ECMO) for cardiogenic shock (CS) is used in over 3,000 patients per year, the best management strategies are not known. Identifying and improving treatment of CS is critically important, as CS occurs in 160,000 patients per year in the US with a 50% mortality rate. VA ECMO is an increasingly used method of mechanical circulatory support (MCS) for patients with CS refractory to medical therapy. Despite the benefit of full cardiopulmonary support ECMO is also thought to increase after load in the failing heart- which paradoxically reduces cardiac output and may lead to myocardial injury and cardiac congestion. A potential solution is to add a device to VA ECMO that decreases after-load - known as left ventricular (LV) unloading. LV unloading can be achieved with different approaches, directly with transvalvular pumps (known as a peripheral ventricular assist device (pVAD)), or indirectly with an intra-aortic balloon pump (IABP)
Preliminary data suggests that unloading the LV is associated with improved survival. Results from a cohort of VA ECMO patients with medical CS, showed a hospital survival benefit LV unloading (aOR 0.87 (0.79, 094); p=0.001). Data has also shown that the survival benefit of LV unloading was much larger with pVAD (HR 0.6), but with higher complications, including limb ischemia - a potentially catastrophic complication. However, results also show that different unloading approaches have different physiologic effects on the myocardium and on peripheral perfusion - highlighting the uncomfortable observation that it is not known how (physiologically) these unloading devices lead to changes in survival.
There are two potential pathways whereby LV unloading could influence survival, including myocardial effects (distension, injury, ejection fraction ) and peripheral effects (peripheral pulse pressure, lactate clearance, CO2 gap). Determining the physiologic effects from LV unloading according to device type and patient etiology will allow us to match the intervention with the patient's physiology. Data suggests that ECMO patients with acute myocardial infarction (AMI) have different mortality and different physiologic changes than patients with decompensated chronic heart failure (CHF) when unloaded.
The ultimate goal is to reduce morbidity and mortality in cardiogenic shock. This study will define the physiologic benefit of LV unloading during CS.
- Conditions
- Cardiogenic Shock
- Being tested
- IABP
- Keywords
- cardiogenic shock, extracorporeal membrane oxygenation, left ventricular unloading
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IABPDevice
Also called LV unloading
LV unloading via intra-aortic balloon pump (IABP)
| Study group | Role | What they receive |
|---|---|---|
| With LV Unloading | Experimental | Patients on VA ECMO who randomize to receive LV unloading Receives: Device: IABP |
| Without LV Unloading | No intervention | Patients on VA ECMO who randomize to receive no LV unloading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary capillary wedge pressure
Change in pulmonary capillary wedge pressure (PCWP) from ECMO start to ECMO day 5 (Day 5 - Baseline) with and without LV unloading
Measured: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Secondary outcomes (14)
Change in pulmonary artery diastolic pressure
Change in pulmonary artery diastolic pressure (PADP) from ECMO start to ECMO day 5 (Day 5 - baseline) with and without LV unloading
Measured: ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Change in left ventricular end diastolic diameter
Change in left ventricular end diastolic diameter (LVEDd) from ECMO start to ECMO day 5 (Day 5 - baseline) with and without LV unloading
Measured: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Change in N-terminal pro b-type natriuretic peptide
Change in N-terminal pro b-type natriuretic peptide (NT-pro BNP) from ECMO start to ECMO day 5 (Day 5 - baseline) with and without LV unloading
Measured: ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Hemodynamic stability
Hemodynamic stability (defined as a change in mean arterial pressure [MAP] from prior to turn down until 2 minutes of wean) at ECMO day 5 with and without LV unloading
Measured: ECMO start, ECMO day 5
Global cardiovascular function
Global cardiovascular function is defined as arterial pulse pressure during the protocoled wean. To assess this outcome, the investigators will calculate the change in pulse pressure from prior to wean to 2 minutes during wean.
Measured: ECMO start, ECMO days 1-5
Difference in partial pressure of carbon dioxide (pCO2)
As part of assessing global cardiovascular function, the investigators will measure, via lab draw, pCO2, which is the difference in CO2 between arterial and central venous blood. This is a marker of peripheral perfusion.
Measured: ECMO start, q12 hours ECMO days 1-3, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Lactate
As part of assessing global cardiovascular function, the investigators will measure, via lab draw, arterial lactate. This is a marker of peripheral perfusion.
Measured: ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Cardiac BIN1
Change in Cardiac BIN1 (cBIN1) serum level from Baseline to Day 5 (Day 5 - Baseline). cBIN1is a validated marker of myocardial recovery in heart failure.
Measured: ECMO start, ECMO day 5, day of ICU discharge up to 6 months
Troponin I
Change in troponin I from ECMO start to ECMO day 5 (Day 5 - Baseline)
Measured: ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Tumor necrosis factor alpha
Change in tumor necrosis factor alpha (TNFa) from ECMO start to ECMO day 5 (Day 5 - Baseline)
Measured: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Ejection fraction percentage
Assessment of heart function via echocardiography
Measured: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Interferon gamma
Predictor of myocardial recovery assessed from baseline through ICU discharge
Measured: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Limb ischemia
Ischemia in the ipsilateral limb as the IABP will be tracked from baseline until 48 hours after the intervention is removed.
Measured: Randomization, 48 hours post-device removal
Mortality
Assessment of patient mortality status at hospital discharge
Measured: Hospital discharge up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start2 Oct 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Joseph Tonna, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336655
- Sponsor's protocol ID
- 153309
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology of Unloading VA ECMO Trial
- ClinicalTrials.gov ID
- NCT06336655
- Acronym / sponsor ID
- 153309
- Conditions
- Cardiogenic Shock
- Keywords
- cardiogenic shock, extracorporeal membrane oxygenation, left ventricular unloading
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 29 Mar 2024 (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 goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for cardiogenic shock (CS). The main aims of the study are:
- To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO
- To determine the effects on myocardial function of adding LV unloading to ECMO
- To test the effects on myocardial recovery of adding LV unloading to VA ECMO
Participants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups.
Detailed description
Although extracorporeal membrane oxygenation (ECMO) for cardiogenic shock (CS) is used in over 3,000 patients per year, the best management strategies are not known. Identifying and improving treatment of CS is critically important, as CS occurs in 160,000 patients per year in the US with a 50% mortality rate. VA ECMO is an increasingly used method of mechanical circulatory support (MCS) for patients with CS refractory to medical therapy. Despite the benefit of full cardiopulmonary support ECMO is also thought to increase after load in the failing heart- which paradoxically reduces cardiac output and may lead to myocardial injury and cardiac congestion. A potential solution is to add a device to VA ECMO that decreases after-load - known as left ventricular (LV) unloading. LV unloading can be achieved with different approaches, directly with transvalvular pumps (known as a peripheral ventricular assist device (pVAD)), or indirectly with an intra-aortic balloon pump (IABP)
Preliminary data suggests that unloading the LV is associated with improved survival. Results from a cohort of VA ECMO patients with medical CS, showed a hospital survival benefit LV unloading (aOR 0.87 (0.79, 094); p=0.001). Data has also shown that the survival benefit of LV unloading was much larger with pVAD (HR 0.6), but with higher complications, including limb ischemia - a potentially catastrophic complication. However, results also show that different unloading approaches have different physiologic effects on the myocardium and on peripheral perfusion - highlighting the uncomfortable observation that it is not known how (physiologically) these unloading devices lead to changes in survival.
There are two potential pathways whereby LV unloading could influence survival, including myocardial effects (distension, injury, ejection fraction ) and peripheral effects (peripheral pulse pressure, lactate clearance, CO2 gap). Determining the physiologic effects from LV unloading according to device type and patient etiology will allow us to match the intervention with the patient's physiology. Data suggests that ECMO patients with acute myocardial infarction (AMI) have different mortality and different physiologic changes than patients with decompensated chronic heart failure (CHF) when unloaded.
The ultimate goal is to reduce morbidity and mortality in cardiogenic shock. This study will define the physiologic benefit of LV unloading during CS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With LV Unloading | Experimental | Device: IABPPatients on VA ECMO who randomize to receive LV unloading |
| Without LV Unloading | No intervention | –Patients on VA ECMO who randomize to receive no LV unloading |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients (age 18 years or older)
- Diagnosis of acute cardiogenic shock (CS)
- Patients failing medical therapy, defined as 1 or more of the following:
Key exclusion criteria (7 listed)
- Metastatic or stage 4 cancer
- Atrial septostomy
- Planned LV unloading on ECMO
- Anticipated death <72 hours
- Existing durable left ventricular assist device (dLVAD)
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 |
|---|---|---|
| IABPAlso: LV unloadingLV unloading via intra-aortic balloon pump (IABP) | Device | With LV Unloading |
Primary outcome
Change in pulmonary capillary wedge pressure
Time frame: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Change in pulmonary capillary wedge pressure (PCWP) from ECMO start to ECMO day 5 (Day 5 - Baseline) with and without LV unloading
14 secondary outcomes
Change in pulmonary artery diastolic pressure
Time frame: ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Change in left ventricular end diastolic diameter
Time frame: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Change in N-terminal pro b-type natriuretic peptide
Time frame: ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Hemodynamic stability
Time frame: ECMO start, ECMO day 5
Global cardiovascular function
Time frame: ECMO start, ECMO days 1-5
Difference in partial pressure of carbon dioxide (pCO2)
Time frame: ECMO start, q12 hours ECMO days 1-3, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Lactate
Time frame: ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Cardiac BIN1
Time frame: ECMO start, ECMO day 5, day of ICU discharge up to 6 months
Troponin I
Time frame: ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Tumor necrosis factor alpha
Time frame: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Ejection fraction percentage
Time frame: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Interferon gamma
Time frame: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
Limb ischemia
Time frame: Randomization, 48 hours post-device removal
Mortality
Time frame: Hospital discharge up to 6 months
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 30 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IABP in people with Cardiogenic Shock, run by University of Utah at 1 site in United States.
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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary capillary wedge pressure (time frame: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months). 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 30 Apr 2026.