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.
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.
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.
Parallel
ibuprofen
DrugIbuprofen tapering schedule during 3 weeks. First week: Ibuprofen 600 mg every 8 hours. Second week: Ibuprofen 600 mg every 12 hours. Third week: Ibuprofen 600 mg every 24 hours.
Change in late gadolinium enhancement (measured in % relative to indexed myocardial mass) compared to baseline (CMR) at admission)
Change in late gadolinium enhancement (measured in % relative to indexed myocardial mass by CMR) compared to baseline at 3 months.
Changes in T2 mapping values (measured in milliseconds by CMR) compared to baseline at 6 months.
Changes in T2 mapping values (measured in milliseconds by CMR) compared to baseline at 3 months.
Changes in T1 mapping values (measured in milliseconds) and extracellular volume (measured in %) by CMR compared to baseline at 6 months.
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Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Lead sponsor
Puerta de Hierro University Hospital
Collaborator
