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Study Comparing Ibuprofen and Acetaminophen for Treating Acute Myocarditis with Normal Heart Function
Led by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III · Updated on 2026-02-13
150
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a 3-week ibuprofen tapering treatment compared to conventional pain relievers like acetaminophen in patients with acute myocarditis who have a normal left ventricular ejection fraction over 50%. This study addresses the unclear treatment options for uncomplicated myocarditis where NSAIDs are controversial but may reduce heart tissue damage as seen on cardiac MRI scans. Participants will be randomly assigned to receive either ibuprofen following a tapering schedule over three weeks or conventional treatment with acetaminophen or metamizole if allergic. The ibuprofen dosing starts at 600 mg every 8 hours in the first week, then every 12 hours in the second week, and every 24 hours in the third week. Treatment will begin during hospital admission, and patients will be monitored over a 12-month period with cardiac MRI scans performed at admission, 3 months, and 6 months. During the study, participants will undergo assessments including cardiac magnetic resonance imaging to measure changes in heart tissue damage, exercise tests, and monitoring for arrhythmias and hospitalizations related to myocarditis or heart complications. Researchers will focus on changes in late gadolinium enhancement at 6 months as the primary outcome and track safety events at 1 month. The study aims to understand how these treatments affect heart health and patient outcomes over time.
CONDITIONS
Brief Title
Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis
Research Team
F
Fernando Domínguez Rodríguez, MD, PhD
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