Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock
Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
In the present study, we aim to investigate the effects of dobutamine infusion and/or a
single intravenous (IV) dose of the IL-6 antagonist Tocilizumab administered after
percutaneous coronary intervention (PCI) to patients with acute myocardial infarction (AMI)
presenting < 24 hours from onset of chest pain and an intermediate to high risk of
cardiogenic shock (CS) by assessment with the ORBI risk score (≥11 - not in overt shock at
hospital admission).
Plasma concentrations of N-terminal pro-B-type natriuretic peptide (NTproBNP) as a proxy for
development of cardiogenic shock (CS) and hemodynamic instability will be sampled for primary
endpoint analysis.
Effects on clinical parameters, mortality, morbidity as well as specific indicators of
inflammation, cardiac function, and infarct size will secondarily be assessed noninvasively.
The rationale behind the current study is that inflammatory and neurohormonal responses are
associated with subclinical hemodynamic instability in patients with AMI with high risk of CS
have worse outcomes. The potentially unstable condition may be targeted pharmacologically as
an add-on to existing therapy. This is investigated in patients at elevated risk of CS by
sampling biomarkers reflecting the inflammatory and neurohormonal responses, as well as
determining effects on patient outcomes and infarct size.
Phase:
Phase 2
Details
Lead Sponsor:
Rigshospitalet, Denmark
Collaborators:
Helge Peetz og Verner Peetz og hustru Vilma Peetz Legat Novo Nordisk A/S Simon Spies Fonden