Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

Phase

Condition

Dermatomyositis (Connective Tissue Disease)

Chest Pain

Treatment

ibuprofen

Clinical Study ID

NCT06686862

2024-513803-15-00

Ages > 18
All Genders

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 Criteria

Inclusion

Inclusion Criteria:

Aged 18 years or older.
Patients hospitalized for confirmed acute myocarditis and left ventricular ejectionfraction 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 CTin individuals over 40 years).
Diagnostic criteria for myocarditis (Lake Louise, 2018 update) by cardiac magneticresonance imaging.

Exclusion

Exclusion Criteria:

Kidney disease stage 3b, 4 and 5 (creatinine clearance by CKD-EPI <45 ml/min/1.73m2).
Severe liver failure (Child-Pugh class C).
Poorly controlled pharmacological hypertension (repeatedly systolic arterialpressure >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 appropriatecontraception throughout the study.
Any circumstance that, in the investigator's opinion, compromises participation inthe clinical trial.

Study Design

ibuprofen

April 28, 2025

October 31, 2027

Study Description

The treatment for patients with uncomplicated myocarditis (left ventricular ejection fraction >50% without heart failure) is not currently well defined. Analgesic drugs are commonly used to manage pain. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) among analgesics is controversial due to potential harmful effects observed in animal models. However, NSAIDs are the standard treatment for pericarditis, even when it is associated with mild myocardial involvement. In patients with acute myocarditis and normal left ventricular ejection fraction, observational studies have suggested that NSAIDs may have a beneficial effect in reducing late gadolinium enhancement (LGE) measured in cardiac magnetic resonance (CMR), an important prognostic marker in this population.

We plan to conduct a prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of NSAIDs versus conventional analgesic treatment in patients with uncomplicated acute myocarditis and left ventricular ejection fraction ≥50%.

Approximately 150 patients will be randomized 1:1 to NSAID treatment (ibuprofen tapering schedule during 3 weeks) or conventional treatment (acetaminophen or metamizole in case of allergy until pain resolution) during hospital admission. Patients will be followed for a 12-month period. Baseline CMR will be performed at initial hospitalization for acute myocarditis and at 3 and 6 months.

The primary objective is to assess the utility of ibuprofen versus conventional treatment with analgesics in acute myocarditis with preserved LVEF, in terms of reducing LGE on CMR at 6-month follow-up compared to baseline.

Connect with a study center

Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid 28222
Spain
Site Not Available
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda 3117667, Madrid 3117732 28222
Spain
Active - Recruiting

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