Using low-dose dobutamine and tocilizumab for treating acute heart attacks at high risk of shock
Low-dose Dobutamine Infusion and Single-dose Tocilizumab in Acute Myocardial Infarction Patients With High Risk of Cardiogenic Shock Development - a 2x2 Multifactorial, Double-blinded, Randomized, Placebo Controlled Trial
This study is testing if a combination of low-dose dobutamine and tocilizumab can help people who have had a heart attack and are at risk of serious complications feel better and recover more effectively.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | Tocilizumab |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05350592 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a low-dose dobutamine infusion and a single intravenous dose of tocilizumab in patients with acute myocardial infarction who are at intermediate to high risk of developing cardiogenic shock. The study involves randomizing eligible patients to receive either the active treatment or a placebo after undergoing percutaneous coronary intervention. Key biomarkers, including proBNP, will be monitored to assess the treatment's impact on hemodynamic stability and inflammation. The trial aims to evaluate both clinical outcomes and specific cardiac function indicators over a defined period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who present with acute myocardial infarction within 24 hours of chest pain and have an ORBI risk score of 10 or higher.
Not a fit: Patients who are in overt cardiogenic shock at admission or have contraindications to the treatments being tested may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve outcomes for patients experiencing acute myocardial infarction and reduce the risk of cardiogenic shock.
How similar studies have performed: While the combination of these specific treatments is novel, previous studies have shown promising results with similar approaches in managing acute myocardial infarction and cardiogenic shock.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute myocardial infarction * Revascularization with PCI * Presentation within 24 hours of chest pain * ORBI risk score ≥ 10 * Age ≥ 18 Exclusion Criteria: * Unwilling to give informed consent to study participation * Unable to give consent due to language barrier * Comatose after cardiac arrest * Cardiogenic shock with systolic blood pressure \< 100 mmHg for more than 30 minutes or need for vasopressor to maintain blood pressure and arterial lactate \> 2,5 (2,0) mmol/L developed before leaving the cath. lab. * Other major clinical non-coronary condition (stroke, sepsis etc.), which can explain a high ORBI risk score * Referral for acute coronary artery bypass grafting (CABG) (\< 24 hours) after the CAG * Contraindications against dobutamine infusion (sustained ventricular tachycardia prior to admission or noted in the cath.lab., known pheochromocytoma, idiopathic hypertrophic subaortic stenosis) * Tocilizumab allergy * Pregnant- or breastfeeding women * Known liver disease/dysfunction * Ongoing uncontrollable infection * Immune deficiency/treatment with immunosuppressants * Known, uncontrolled gastrointestinal (GI) disease predisposing to GI perforation
Where this trial is running
Copenhagen
- Rigshospitalet, Copenhagen University Hospital — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Helle Søholm, MD, PhD — Dept. of Cardiology, Rigshospitalet
- Study coordinator: Helle Soeholm, MD, PhD
- Email: helle.soeholm@regionh.dk
- Phone: +4535454842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.