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Beta receptor modulation trial in cardiogenic shock patients supported by V-A ECMO
EU CTIS ID: 2024-511805-42-00
What this study is testing
1. To demonstrate safety and feasibility of a strategy involving a reduction in BR stimulation and subsequent inhibition through application of an intravenous BB (BR inhibition). 2. To study the effect of a beta receptor inhibition strategy versus a strategy to continue beta receptor stimulation (as is done in routine clinical care) on heart rate.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Having received V-A ECMO support for severe circulatory insufficiency due to left- or bi-ventricular failure
- ≤ 16 hours after initiation of V-A ECMO support
- Receiving ≥ 2 mcg/kg/min of dobutamine
- Norepinephrine infusion ≤ 0.6 mcg/kg/min
- Heart rate of ≥ 80 bpm (being sinus rhythm, atrial fibrillation or atrial flutter) after V-A ECMO initiation
You likely can't join if
- Objection during the deferred consent procedure
- Second- or third- degree AV block
- Pregnancy
- Estimated life expectancy of < 24 hours
- Participation in another randomized clinical trial
- Inability to start study treatment within 4 hours after randomization
See the full eligibility criteria
- Age ≥ 18 years
- Having received V-A ECMO support for severe circulatory insufficiency due to left- or bi-ventricular failure
- ≤ 16 hours after initiation of V-A ECMO support
- Receiving ≥ 2 mcg/kg/min of dobutamine
- Norepinephrine infusion ≤ 0.6 mcg/kg/min
- Heart rate of ≥ 80 bpm (being sinus rhythm, atrial fibrillation or atrial flutter) after V-A ECMO initiation
- Objection during the deferred consent procedure
- Second- or third- degree AV block
- Pregnancy
- Estimated life expectancy of < 24 hours
- Participation in another randomized clinical trial
- Inability to start study treatment within 4 hours after randomization
- Post heart transplantation patients
- V-A ECMO usage confined to the period during surgery or another intervention (the ECMO was removed at the end of the intervention)
- Concomittant durable LVAD
- Polymorphic ventricular tachycardia necessitating betablocker therapy
- Isolated right ventricular failure (e.g. due to pulmonary embolism)
- Need of high dose dobutamine > 6.0 mcg/kg/min
- Epinephrine infusion
- Signs of insufficient trans cardiac flow (Absence of aortic valve opening, pulse pressure <10 mmHg (with IABP standby), spontaneous contrast in the heart at echocardiography)
- Contraindications for-, intolerance to- or allergy to esmolol
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.