Beta receptor modulation for heart failure treatment

Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation - Beta Receptor Modulation Trial

This study is testing if using beta blockers instead of just dobutamine can help patients with heart failure on ECMO feel better and have better outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Erasmus Medical Center (Academic / other)
• Locations: 1 site (Rotterdam, South Holland)
• Trial ID: NCT06522594 on ClinicalTrials.gov

What this trial studies

This phase 2 pilot trial investigates the effects of reducing beta receptor stimulation and applying beta blockers in patients with cardiogenic shock supported by Veno-Arterial ExtraCorporeal Membrane Oxygenation (V-A ECMO). The study compares a strategy of decreasing dobutamine dosages and administering ultra-short acting beta blockers against a routine approach that continues dobutamine infusion. The goal is to assess the safety and feasibility of beta blockers in reducing heart rate and improving outcomes in this high-risk patient population. The trial aims to shift the therapeutic focus towards cardioprotective treatments during ECMO support.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are receiving V-A ECMO support for severe circulatory insufficiency due to left- or bi-ventricular failure.

Not a fit: Patients with isolated right ventricular failure or those requiring high doses of dobutamine may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve heart recovery and reduce mortality rates in patients with cardiogenic shock.

How similar studies have performed: While the use of beta blockers in heart failure has shown benefits in other contexts, this specific approach in conjunction with V-A ECMO is novel and has not been extensively tested.

Eligibility criteria

Inclusion 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 ≤ 0.4 mcg/kg/min
* Heart rate ≥ 80 bpm (being sinus rhythm, atrial fibrillation or atrial flutter) after V-A ECMO initiation

Exclusion Criteria:

* Objection during the deferred consent procedure
* V-A ECMO usage confined to the period during surgery or another intervention (the ECMO was removed at the end of the intervention).
* Concomitant durable Left Ventricular Assist Device (LVAD)
* Polymorphic ventricular tachycardia necessitating BB 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 intra-aortic balloon pump (IABP) standby)
  * Spontaneous contrast in the heart at echocardiography
* Contraindications for-, intolerance to- or allergy to esmolol
* Second- or third- degree AV block
* Pregnancy
* Life expectancy of less than 24 hours
* Participation in another randomized clinical trial (e.g. On Scene trial or Left Ventricular unloading trial)
* Inability to start study treatment within 4 hours after randomization
* Post heart transplantation patients

Where this trial is running

Rotterdam, South Holland

• Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Christiaan L. Meuwese — Erasmus Medical Center
• Study coordinator: Christiaan L. Meuwese, MD, PhD

Conditions Heart Failure; Cardiogenic Shock; Veno-Arterial ExtraCorporeal Membrane Oxygenation; Betablocker; Esmolol; Cardiogenic shock