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RECRUITING
NCT06686862
PHASE3

Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

View on ClinicalTrials.gov

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.

Official title: Non-Steroidal Anti-Inflammatory Drugs Versus Conventional Treatment in Acute Myocarditis (INFLAMA Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-04-28

Completion Date

2027-10

Last Updated

2026-02-13

Healthy Volunteers

No

Interventions

DRUG

ibuprofen

Ibuprofen tapering schedule during 3 weeks. First week: Ibuprofen 600 mg every 8 hours. Second week: Ibuprofen 600 mg every 12 hours. Third week: Ibuprofen 600 mg every 24 hours.

Locations (1)

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, Spain