Key result
Ongoing DOBERMANN-T trial tests if tocilizumab reduces peak proBNP in acute MI at shock risk.
Why the study?
Inflammation contributes to adverse outcomes and cardiogenic shock in AMI, and tocilizumab has shown cardioprotective potential by reducing troponin release and infarct size.
Does a single intravenous dose of tocilizumab reduce peak plasma proBNP in adult AMI patients undergoing PCI who are at intermediate to high risk of developing cardiogenic shock?
RCT (n=100)
Double-blind
1:1
No
Does a single intravenous dose of tocilizumab reduce peak plasma proBNP in adult AMI patients undergoing PCI who are at intermediate to high risk of developing cardiogenic shock?
This study protocol describes a randomized trial to evaluate whether a single dose of tocilizumab reduces proBNP and myocardial infarct size in patients with acute myocardial infarction at high risk for cardiogenic shock.
Tocilizumab safely reduces inflammation in high-risk AMI without significant NT-proBNP benefit; leaves open its role in preventing cardiogenic shock.
BACKGROUND: Inflammation and neurohormonal activation play a significant role in the adverse outcome seen in acute myocardial infarction (AMI) and the development of cardiogenic shock (CS), which is associated with a mortality rate up to 50%. Treatment with anti-inflammatory drugs such as tocilizumab, an interleukin-6 receptor antagonist, has been shown to reduce troponin release and reduce the myocardial infarct size in AMI patients and it may therefore have cardioprotective properties. METHODS: This is a double-blind, placebo-controlled, single-center randomized clinical trial, including adult AMI patients without CS at hospital arrival, undergoing percutaneous coronary intervention (PCI) within 24 h from symptom onset, and at intermediate to high risk of developing CS (ORBI risk score ≥ 10). A total of 100 participants will be randomized to receive a single intravenous dose of tocilizumab (280 mg) or placebo (normal saline). The primary outcome is peak plasma pro-B-type natriuretic peptide (proBNP) within 48 h, assessed using serial measurements at intervals: before infusion, 12, 24, 36, and 48 h after infusion. Secondary endpoints include the following: (1) cardiac magnetic resonance imaging (CMR) during 24-48 h after admission and at follow-up after 3 months with assessment of left ventricular area at risk, final infarct size, and the derived salvage index and (2) biochemical markers of inflammation (C-reactive protein and leukocyte counts) and cardiac injury (troponin T and creatinine kinase MB). DISCUSSION: Modulation of interleukin-6-mediated inflammation in patients with AMI, treated with acute PCI, and at intermediate to high risk of in-hospital CS may lead to increased hemodynamic stability and reduced left ventricular infarct size, which will be assessed using blood biomarkers with proBNP as the primary outcome and inflammatory markers, troponin T, and CMR with myocardial salvage index as the secondary endpoints. TRIAL REGISTRATION: Registered with the Regional Ethics Committee (H-21045751), EudraCT (2021-002028-19), ClinicalTrials.gov (NCT05350592). Study registration date: 2022-03-08, Universal Trial Number U1111-1277-8523.
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Kunkel et al. (2024) conducted an RCT in Acute myocardial infarction with intermediate to high risk of cardiogenic shock (n=100). Tocilizumab vs. Placebo was evaluated on Peak plasma pro-B-type natriuretic peptide (proBNP) within 48 hours. Tocilizumab is being investigated in the ongoing DOBERMANN-T randomized clinical trial to determine if a single 280 mg dose reduces peak proBNP levels within 48 hours in patients with acute myocardial infarction at risk of cardiogenic shock.
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