Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

Recruiting now · Phase 3

Conditions studied: Myocarditis Acute

In brief

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.

Key facts

Study ID

NCT06686862

Run by

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

People needed

150

Starts

2025-04-28

Expected to finish

2027-10-01

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Universitario Puerta de Hierro-Majadahonda — Majadahonda, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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