NCT06336655 Physiology of Unloading VA ECMO Trial
| NCT ID | NCT06336655 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Utah |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2024-10-02 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 104 participants in total. It began in 2024-10-02 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06336655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06336655 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06336655 currently recruiting?
Yes, NCT06336655 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Utah to inquire about joining.
Where is the NCT06336655 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06336655 clinical trial?
NCT06336655 is sponsored by University of Utah. The trial plans to enroll 104 participants.