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LOW-DOSE DOBUTAMINE INFUSION AND SINGLE-DOSE TOCILIZUMAB IN ACUTE MYOCARDIAL INFARCTION PATIENTS WITH HIGH RISK OF CARDIOGENIC SHOCK DEVELOPMENT (DOBERMANN) - A 2X2 MULTIFACTORIAL, DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515999-13-00
Acronym
RH-CARD-Pharma001
Enrollment
100
Registered
2024-09-25
Start date
2022-03-13
Completion date
2025-09-30
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction with increased risk of Cardiogenic Shock

Brief summary

NTproBNP in blood samples drawn from hospital admission to 48 hours after admission.

Detailed description

Infarct size measured by cMRi during index admission and after 3 months, Biomarkers reflecting neurohormonal activation, endothelial function/damage, inflammation (pro- and anti-inflammatory processes – including IL-6 and C-reactive peptide (CRP)), connec-tive tissue damage, organ dysfunction, and other relevant processes, 2D echocardiographic measurements of hemodynamics (VTI) and left ventricular function including strain measurements according to protocol, SOFA score (PaO2, FiO2, on medical ventilation, Platelets, GCS, Bilirubin, mean arterial pressure OR administration of vasoactive agents required, Creatinine, COVID-19 status), Development of in-hospital CS and/or in-hospital cardiac arrest and/or transfer to the ICU during index admission, Long-term all-cause mortality, PCI operator's post-procedure clinical assessment of the patient (survives to discharge 'yes/no'), Development of non-cardiac arrest arrythmia (sustained ventricular tachycardia, atrial fibrillation with a frequency above 120 for more than 30 minutes) during index admission (safety), Re-admission (all cause and cardiovascular) during the first year after index hospitalization, Re-admission with heart failure and re-infarction during the first year after index hospitalization, Quality of Life and mental and cognitive health at baseline and after three months

Interventions

DRUGopløsning
DRUGIsoton (0
DRUG9%) NaCl
DRUGRoActemra 20 mg/mL concentrate for solution for infusion

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
NTproBNP in blood samples drawn from hospital admission to 48 hours after admission.

Secondary

MeasureTime frame
Infarct size measured by cMRi during index admission and after 3 months, Biomarkers reflecting neurohormonal activation, endothelial function/damage, inflammation (pro- and anti-inflammatory processes – including IL-6 and C-reactive peptide (CRP)), connec-tive tissue damage, organ dysfunction, and other relevant processes, 2D echocardiographic measurements of hemodynamics (VTI) and left ventricular function including strain measurements according to protocol, SOFA score (PaO2, FiO2, on medical ventilation, Platelets, GCS, Bilirubin, mean arterial pressure OR administration of vasoactive agents required, Creatinine, COVID-19 status), Development of in-hospital CS and/or in-hospital cardiac arrest and/or transfer to the ICU during index admission, Long-term all-cause mortality, PCI operator's post-procedure clinical assessment of the patient (survives to discharge 'yes/no'), Development of non-cardiac arrest arrythmia (sustained ventricular tachycardia, atrial fibrillation with a frequen

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026