Actively Recruiting
Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis
Led by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III · Updated on 2026-02-13
150
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
F
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Lead Sponsor
F
Fundación Investigación Biomédica Puerta de Hierro Majadahonda
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 greater than 50%
- Elevated troponin I or T levels at least three times above the upper limit of normal
- No acute heart failure present
- No ischemic heart disease as confirmed by coronary angiography or coronary CT scan (for those over 40 years old)
- Meets diagnostic criteria for myocarditis by cardiac magnetic resonance imaging (Lake Louise 2018 update)
You will not qualify if you...
- Kidney disease stage 3b, 4, or 5 with creatinine clearance less than 45 ml/min/1.73 m2
- Severe liver failure (Child-Pugh class C)
- Poorly controlled high blood pressure (systolic pressure repeatedly over 140 mmHg)
- Diagnosed acute pericarditis
- Moderate or severe pericardial fluid accumulation (more than 10 mm)
- Allergic to NSAIDs or used NSAIDs in the last 7 days
- Cannot undergo MRI
- Currently participating in another clinical trial
- Pregnant, breastfeeding, or women of childbearing age not using contraception
- Any condition that the investigator believes would interfere with participation
AI-Screening
AI-Powered Screening
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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
CONTACT
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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