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Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

RecruitingPhase 3Ages 18 Years - anyAllFundación Centro Nacional de Investigaciones Card…
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In plain words

What the trial is, and whether it could suit you

Prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of a 3-week ibuprofen tapering regimen compared to conventional analgesic treatment (acetaminophen) in patients with acute myocarditis and left ventricular ejection fraction ≥50%. The objective is to assess the reduction in late gadolinium enhancement on cardiac magnetic resonance imaging at 6-month follow-up.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 18 years or older. * Patients hospitalized for confirmed acute myocarditis and left ventricular ejection fraction ventricular \>50%. * Elevated troponin I/T (3 times above the upper limit of normal). * Absence of acute heart failure. * Absence of ischemic heart disease (ruled out by coronary angiography or coronary CT in individuals over 40 years). * Diagnostic criteria for myocarditis (Lake Louise, 2018 update) by cardiac magnetic resonance imaging. Exclusion Criteria: * Kidney disease stage 3b, 4 and 5 (creatinine clearance by CKD-EPI \<45 ml/min/1.73 m2). * Severe liver failure (Child-Pugh class C). * Poorly controlled pharmacological hypertension (repeatedly systolic arterial pressure \>140 mmHg). * Diagnosis criteria for acute pericarditis. * Moderate or severe pericardial effusion (\>10 mm in total). * Hypersensitivity to NSAIDs or previous use in the last 7 days. * Contraindication for MRI. * Participation in another clinical trial. * Pregnancy, breastfeeding, or women of childbearing age unwilling to use appropriate contraception throughout the study. * Any circumstance that, in the investigator's opinion, compromises participation in the clinical trial.
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What it tests

  • ibuprofen
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Where

1 site
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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