RecruitingPhase 3NCT06686862

Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

Non-Steroidal Anti-Inflammatory Drugs Versus Conventional Treatment in Acute Myocarditis (INFLAMA Trial)

Sponsor

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Enrollment

150 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

Myocarditis Acute

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria10

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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Interventions

DRUGibuprofen

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.