ibuprofen: Ibuprofen 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in late gadolinium enhancement (measured in % relative to indexed myocardial mass) compared to baseline (CMR) at admission) — 6 months
Trial sites (1)
Facility
City
Region
Status
Hospital Universitario Puerta de Hierro-Majadahonda
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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