A Phase 3 interventional study of ibuprofen in Myocarditis Acute, sponsored by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III · Phase 3, Interventional, and Treatment
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.
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.
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ibuprofen tapering schedule during 3 weeks.
Drug: ibuprofen
Acetaminophen or metamizole in case of allergy until pain resolution, according to routine clinical practice.
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.
Change in late gadolinium enhancement (measured in % relative to indexed myocardial mass) compared to baseline (CMR) at admission)
Time frame: 6 months
Change in late gadolinium enhancement (measured in % relative to indexed myocardial mass by CMR) compared to baseline at 3 months.
Time frame: 3 months
Changes in T2 mapping values (measured in milliseconds by CMR) compared to baseline at 6 months.
Time frame: 6 months
Changes in T2 mapping values (measured in milliseconds by CMR) compared to baseline at 3 months.
Time frame: 3 months
Changes in T1 mapping values (measured in milliseconds) and extracellular volume (measured in %) by CMR compared to baseline at 6 months.
Time frame: 6 months
Changes in T1 mapping values (measured in milliseconds) and extracellular volume (measured in %) by CMR compared to baseline at 3 months.
Time frame: 3 months
Compare exercise capacity using METs (metabolic equivalent) in conventional treadmill exercise test at 3 months.
Time frame: 3 months
Proportion of patients experiencing arrhythmias during treadmill exercise test at 3 months
Time frame: 3 months
Proportion of patients from each group experiencing hospitalization due to recurrent myocarditis, heart failure, severe ventricular arrhythmias, or cardiovascular death at 12 months.
Time frame: 1 year
Proportion of patients developing adverse events in each treatment group at 1 month
Adverse events: severe adverse event, grade 3-4 adverse event, adverse reaction, special interest adverse event.
Time frame: 1 month
Plan to share: Yes — Under agreement, individual or aggregated patient data could be shared with other scientific groups for scientific projects. Data can be shared only for scientific purposes and in full compliance with Personal Data Protection requirements in the EU.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
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Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III