IABP with VA ECMO for Cardiogenic Shock

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Utah

Disqualifiers: Metastatic cancer, Atrial septostomy, Pregnancy, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO 2. To determine the effects on myocardial function of adding LV unloading to ECMO 3. 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Intra-aortic Balloon Pump (IABP) with VA ECMO for Cardiogenic Shock?

Research suggests that using an intra-aortic balloon pump (IABP) along with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) may reduce in-hospital deaths in patients with cardiogenic shock compared to using VA-ECMO alone. A study found that patients receiving both treatments had a lower death rate (58.4%) compared to those with only VA-ECMO (63.1%). ^{1 2 3 4 5}

Is the combination of IABP and VA-ECMO generally safe for humans?

The safety of using an intra-aortic balloon pump (IABP) with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for cardiogenic shock is not fully clear, as studies show mixed results. While IABP may help improve heart function, the risks and benefits in real-life settings have not been thoroughly evaluated. ^{1 2 4 6 7}

How does the treatment of IABP with VA ECMO for cardiogenic shock differ from other treatments?

This treatment combines two technologies: the intra-aortic balloon pump (IABP), which helps the heart pump more effectively, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO), which provides heart and lung support. This combination is unique because it aims to improve blood flow and reduce the heart's workload simultaneously, which is not typically achieved with standard treatments. ^{1 2 3 4 8}

Research Team

Eligibility Criteria

This trial is for patients with non-postoperative cardiogenic shock, a severe heart condition where the heart can't pump enough blood. Participants must be receiving veno-arterial extracorporeal membrane oxygenation (VA ECMO) treatment.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with acute heart failure.

My heart condition is worsening despite medical treatment.

Exclusion Criteria

My cancer has spread to other parts of my body.

Planned LV unloading on ECMO

Anticipated death <72 hours

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive VA ECMO with or without LV unloading, with measurements taken via lab work, echocardiography, and pulmonary artery catheter

Up to 6 months

Daily monitoring during ECMO, regular follow-ups until ICU discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of myocardial recovery and mortality

Up to 6 months

Regular follow-ups until hospital discharge

Treatment Details

Interventions

• Intra-aortic Balloon Pump (Device)

Trial Overview The study compares two approaches: one group receives VA ECMO alone, while the other gets VA ECMO plus left ventricular unloading using an intra-aortic balloon pump (IABP). The effects on heart and lung function will be measured through lab tests, echocardiography, and pulmonary artery catheter data.

Participant Groups

Group I: With LV Unloading Experimental Treatment 1 Intervention

Patients on VA ECMO who randomize to receive LV unloading

Group II: Without LV Unloading Active Control 1 Intervention

Patients on VA ECMO who randomize to receive no LV unloading

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Utah Salt Lake City, UT

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1169

Patients Recruited

1,623,000+

University of Minnesota

Collaborator

Trials

1459

Patients Recruited

1,623,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant Intra-Aortic Balloon Pump Use in Cardiogenic Shock Requiring Veno-Arterial Extracorporeal Membrane Oxygenation. Vallabhajosyula, S., O'Horo, JC., Antharam, P., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venoarterial extracorporeal membrane oxygenation with intra-aortic balloon pump for postcardiotomy cardiogenic shock: A systematic review and meta-analysis. Huang, D., Xu, A., Guan, Q., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left ventricular decompression on Veno-arterial extracorporeal membrane oxygenation with intra-aortic balloon Counterpulsation. Griffin, JM., Restaino, S., Takeda, K., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracorporeal life support for cardiogenic shock: influence of concomitant intra-aortic balloon counterpulsation. Ro, SK., Kim, JB., Jung, SH., et al.[2014]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an intra-aortic balloon pump with venoarterial extracorporeal membrane oxygenation on mortality of patients with cardiogenic shock: a systematic review and meta-analysis†. Li, Y., Yan, S., Gao, S., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-aortic balloon counterpulsation in the emergency department: a 7-year review and analysis of predictors of survival. Bur, A., Bayegan, K., Holzer, M., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Change in ESC Guidelines on Clinical Characteristics and Outcomes of Cardiogenic Shock Patients Receiving IABP Therapy. Nevzorov, R., Daum, A., Jafari, J., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intra-aortic balloon pump with veno-arterial extracorporeal membrane oxygenation in acute myocardial infarction with cardiogenic shock: A meta-analysis. Liu, Y., Zeng, M., Zhou, Y., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Concomitant Intra-Aortic Balloon Pump Use in Cardiogenic Shock Requiring Veno-Arterial Extracorporeal Membrane Oxygenation. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Venoarterial extracorporeal membrane oxygenation with intra-aortic balloon pump for postcardiotomy cardiogenic shock: A systematic review and meta-analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Left ventricular decompression on Veno-arterial extracorporeal membrane oxygenation with intra-aortic balloon Counterpulsation. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Extracorporeal life support for cardiogenic shock: influence of concomitant intra-aortic balloon counterpulsation. [2014]

5. Germany pubmed.ncbi.nlm.nih.gov

Effect of an intra-aortic balloon pump with venoarterial extracorporeal membrane oxygenation on mortality of patients with cardiogenic shock: a systematic review and meta-analysis†. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

Intra-aortic balloon counterpulsation in the emergency department: a 7-year review and analysis of predictors of survival. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of the Change in ESC Guidelines on Clinical Characteristics and Outcomes of Cardiogenic Shock Patients Receiving IABP Therapy. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Effect of intra-aortic balloon pump with veno-arterial extracorporeal membrane oxygenation in acute myocardial infarction with cardiogenic shock: A meta-analysis. [2023]