Recruiting
Phase 2

Observational Study

Sponsor:

University of Utah

Code:

NCT06336655

Conditions

Cardiogenic Shock

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IABP

Study Details

Brief 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. 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.

Conditions

Cardiogenic Shock

Study ID

NCT06336655

Start date

Oct 2, 2024

Status verified date

Apr, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. Society for Coronary Angiography and Interventions (SCAI) Stage C or greater
2. 2 or more inotropic medications and not improving
3. IABP in place and clinically worsening
4. Placed on VA ECMO for CS
5. In the opinion of the attending physician, patient has worsening CS and could require VA ECMO support in the near-term

Exclusion Criteria:

  • 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

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: With LV Unloading

Patients on VA ECMO who randomize to receive LV unloading

no intervention: Without LV Unloading

Patients on VA ECMO who randomize to receive no LV unloading

Interventions

IABP

LV unloading via intra-aortic balloon pump (IABP)

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 ]

Central Contacts and Locations

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Joseph E. Tonna, MD, FAAEM

801.587.9373joseph.tonna@hsc.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • cardiogenic shock
  • extracorporeal membrane oxygenation
  • left ventricular unloading

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-04-30.