RecruitingPhase 2

Physiology of Unloading VA ECMO Trial

United States104 participantsStarted 2024-10-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pulmonary capillary wedge pressure

Timeframe: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months

Trial details

NCT IDNCT06336655

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-01

View on ClinicalTrials.gov More Cardiogenic Shock trials