Actively Recruiting
Non-Steroidal Anti-Inflammatory Drugs Versus Conventional Treatment in Acute Myocarditis (INFLAMA Trial)
Led by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III · Updated on 2026-02-13
150
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
F
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Lead Sponsor
P
Puerta de Hierro University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a 3-week ibuprofen tapering treatment compared to conventional pain relievers like acetaminophen in patients with acute myocarditis who have a normal left ventricular ejection fraction (over 50%). This study addresses the unclear treatment options for uncomplicated myocarditis where NSAIDs are controversial but may reduce heart tissue damage as seen on cardiac MRI scans. Participants will be randomly assigned to receive either ibuprofen following a tapering schedule over three weeks or conventional treatment with acetaminophen or metamizole if allergic. The ibuprofen dosing starts at 600 mg every 8 hours in the first week, then every 12 hours in the second week, and every 24 hours in the third week. Treatment will begin during hospital admission, and patients will be monitored over a 12-month period with cardiac MRI scans performed at admission, 3 months, and 6 months. During the study, participants will undergo assessments including cardiac magnetic resonance imaging to measure changes in heart tissue damage, exercise tests, and monitoring for arrhythmias and hospitalizations related to myocarditis or heart complications. Researchers will focus on changes in late gadolinium enhancement at 6 months as the primary outcome and track safety events at 1 month. The study aims to understand how these treatments affect heart health and patient outcomes over time.
CONDITIONS
Brief Title
Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older.
- Hospitalized for confirmed acute myocarditis with left ventricular ejection fraction over 50%.
- Elevated troponin I or T levels at least three times above the upper normal limit.
- No acute heart failure.
- No ischemic heart disease confirmed by coronary angiography or CT in individuals over 40 years.
- Meet diagnostic criteria for myocarditis by cardiac magnetic resonance imaging according to Lake Louise 2018 update.
You will not qualify if you...
- Kidney disease stage 3b, 4, or 5 with creatinine clearance below 45 ml/min/1.73 m2.
- Severe liver failure (Child-Pugh class C).
- Poorly controlled high blood pressure with repeated systolic pressure over 140 mmHg.
- Diagnosis of acute pericarditis.
- Moderate or severe pericardial effusion greater than 10 mm.
- Allergy or hypersensitivity to NSAIDs or use of NSAIDs in the last 7 days.
- Contraindication for MRI.
- Participation in another clinical trial.
- Pregnancy, breastfeeding, or women of childbearing age not using contraception.
- Any other condition that may compromise participation as judged by the investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 weeks
Participants receive either ibuprofen following a tapering schedule over 3 weeks or conventional analgesic treatment until pain resolution during hospital admission.
Hospital admission with treatment duration of up to 3 weeks
Duration - 12 months
Participants are followed for safety and efficacy assessments including cardiac MRI scans and treadmill exercise tests.
Visits at 3, 6, and 12 months including cardiac MRI and treadmill exercise tests
Trial Site Locations
Total: 1 location
1
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
Research Team
F
Fernando Domínguez Rodríguez, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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