Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis
Key facts
- Where
- Barcelona, Burgos, Leganés, Majadahonda, Murcia, and Salamanca, SpainSee the 7 sites
- Phase
- Phase 3
Where in Spain
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario De BurgosBurgos, SpainTaking people
- Hospital Universitario Severo OchoaLeganés, SpainTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpainTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Trial code
- NCT06686862EU 2024-513803-15-00
- Record updated
- 13 February 2026
- Original description
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.Read full original descriptionShow less
Non-Steroidal Anti-Inflammatory Drugs Versus Conventional Treatment in Acute Myocarditis (INFLAMA Trial)
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.
Inclusion: 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: Hypersensitivity to NSAIDs or previous use in the last 7 days; Severe liver failure (Child-Pugh class C); Poorly controlled pharmacological hypertension (repeatedly systolic arterial pressure >140 mmHg); Kidney disease stage 3b, 4 and 5 (creatinine clearance by CKD-EPI <45 ml/min/1.73 m2); Pregnancy, breastfeeding, or women of childbearing age unwilling to use appropriate contraception throughout the study; Diagnosis criteria for acute pericarditis; Moderate or severe pericardial effusion (>10 mm in total); Contraindication for MRI; Participation in another clinical trial; Any circumstance that, in the investigator's opinion, compromises participation in the clinical trial.