Ibuprofen versus acetaminophen for uncomplicated acute myocarditis
Non-Steroidal Anti-Inflammatory Drugs Versus Conventional Treatment in Acute Myocarditis (INFLAMA Trial)
This trial will test whether a 3-week ibuprofen taper compared with acetaminophen helps adults hospitalized with uncomplicated acute myocarditis (LVEF ≥50%) reduce heart scarring seen on cardiac MRI at 6 months.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III Academic / other |
| Locations | 1 site (Majadahonda, Madrid) |
| Trial ID | NCT06686862 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults hospitalized for confirmed acute myocarditis with LVEF ≥50%, elevated troponin, no signs of acute heart failure, able to undergo MRI, and without contraindications to NSAIDs are the ideal candidates.
Not a fit: Patients with reduced LVEF, moderate or severe pericardial disease, advanced kidney or liver failure, NSAID hypersensitivity, pregnancy, MRI contraindications, or other exclusion criteria are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, ibuprofen could reduce MRI-detected myocardial scarring and potentially improve longer-term outcomes for patients with uncomplicated acute myocarditis.
How similar studies have performed: Observational studies have suggested NSAIDs may reduce late gadolinium enhancement in this subgroup and NSAIDs are standard for pericarditis, but randomized controlled data in uncomplicated myocarditis are limited and some animal models have shown potential harm.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Majadahonda, Madrid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.