Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ibuprofen

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators