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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitario Puerta de Hierro-Majadahonda
RECRUITING
Majadahonda
Contact Information
Primary
Fernando Domínguez Rodríguez, MD, PhD
fdominguezr@salud.madrid.org
+34 91 1916000
Time Frame
Start Date: 2025-04-28
Estimated Completion Date: 2027-10
Participants
Target number of participants: 150
Treatments
Experimental: Ibuprofen
Ibuprofen tapering schedule during 3 weeks.
No_intervention: Acetaminophen
Acetaminophen or metamizole in case of allergy until pain resolution, according to routine clinical practice.
Related Therapeutic Areas
Sponsors
Collaborators: Fundación Investigación Biomédica Puerta de Hierro Majadahonda
Leads: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

This content was sourced from clinicaltrials.gov