About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ibuprofen
Treatment groups
Sponsors and collaborators
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Lead sponsor
Puerta de Hierro University Hospital
Collaborator