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Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock

NCT05350592 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-17

No results posted yet for this study

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 (≥10 - not in overt shock at hospital admission).

Plasma concentrations of pro-B-type natriuretic peptide (proBNP) 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.

Conditions

  • Acute Myocardial Infarction
  • Cardiogenic Shock

Interventions

DRUG

Tocilizumab

Single bolus

DRUG

Dobutamine

Continous weight-adjusted infusion

DRUG

NaCl 0.9%

Placebo comparator and diluent

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Simon Spies Fonden

    collaborator UNKNOWN

  • Helge Peetz og Verner Peetz og hustru Vilma Peetz Legat

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Helle Søholm, MD, PhD · Dept. of Cardiology, Rigshospitalet

  • Martin Frydland, MD, PhD · Dept. of Cardiology, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-13
Primary Completion
2025-06-30
Completion
2025-09-30

Countries

  • Denmark

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350592 on ClinicalTrials.gov