Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis
Spain150 participantsStarted 2025-04-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in late gadolinium enhancement (measured in % relative to indexed myocardial mass) compared to baseline (CMR) at admission)
Timeframe: 6 months
Trial details
NCT IDNCT06686862
SponsorFundación Centro Nacional de Investigaciones Cardiovasculares Carlos III