Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis
A legfontosabb adatok
- Fázis
- 3. fázis
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Azonosító
- NCT06686862EU 2024-513803-15-00
- A regiszteradat frissítve
- 2026. február 13.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.