Ibuprofen versus acetaminophen for uncomplicated acute myocarditis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, multicenter, open-label Phase 3 trial enrolling about 150 adults with confirmed uncomplicated acute myocarditis and preserved left ventricular ejection fraction, randomized 1:1 to a 3-week ibuprofen taper or to conventional analgesics (acetaminophen or metamizole). Baseline cardiac MRI will be obtained during admission with follow-up CMR at 3 and 6 months and clinical follow-up to 12 months. The primary endpoint is change in late gadolinium enhancement on CMR at 6 months, with predefined safety monitoring for NSAID-related adverse events. The trial seeks to determine whether NSAID therapy reduces MRI-detected myocardial scarring compared with standard analgesic care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Puerta de Hierro-Majadahonda
  Majadahonda, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Fernando Domínguez-Rodriguez, MD, PhD — Heart Failure and Inherited Cardiac Diseases Unit, Department of Cardiology, Hospital Universitario Puerta de Hierro, IDIPHISA, Madrid, Spain
• Study coordinator: Fernando Domínguez Rodríguez, MD, PhD
• Email: fdominguezr@salud.madrid.org
• Phone: +34 91 1916000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.