Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

NCT06686862 | Recruiting Phase 3

• 1 other identifier: 2024-513803-15-00
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocarditis Acute

Keywords

Nonsteroidal antiinflammatory agents; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Change in late gadolinium enhancement (measured in % relative to indexed myocardial mass) compared to baseline (CMR) at admission)

  6 months

Secondary Outcomes (9)

• Change in late gadolinium enhancement (measured in % relative to indexed myocardial mass by CMR) compared to baseline at 3 months.

  3 months

• Changes in T2 mapping values (measured in milliseconds by CMR) compared to baseline at 6 months.

  6 months

• Changes in T2 mapping values (measured in milliseconds by CMR) compared to baseline at 3 months.

  3 months

• Changes in T1 mapping values (measured in milliseconds) and extracellular volume (measured in %) by CMR compared to baseline at 6 months.

  6 months

• Changes in T1 mapping values (measured in milliseconds) and extracellular volume (measured in %) by CMR compared to baseline at 3 months.

  3 months

Study Arms (2)

Ibuprofen

EXPERIMENTAL

Ibuprofen tapering schedule during 3 weeks.

Drug: ibuprofen

Acetaminophen

NO INTERVENTION

Acetaminophen or metamizole in case of allergy until pain resolution, according to routine clinical practice.

Interventions

ibuprofen DRUG

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.

Ibuprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Moderate or severe pericardial effusion (\>10 mm in total).
• Hypersensitivity to NSAIDs or previous use in the last 7 days.
• Contraindication for MRI.
• Participation in another clinical trial.
• Pregnancy, breastfeeding, or women of childbearing age unwilling to use appropriate contraception throughout the study.
• Any circumstance that, in the investigator's opinion, compromises participation in the clinical trial.

Sponsors & Collaborators

• Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III: lead
• Fundación Investigación Biomédica Puerta de Hierro Majadahonda: collaborator

Study Sites (1)

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, 28222, Spain

RECRUITING

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Fernando Domínguez-Rodriguez, MD, PhD

  Heart Failure and Inherited Cardiac Diseases Unit, Department of Cardiology, Hospital Universitario Puerta de Hierro, IDIPHISA, Madrid, Spain

  PRINCIPAL INVESTIGATOR

• Pablo García-Pavía, MD, PhD

  Heart Failure and Inherited Cardiac Diseases Unit, Department of Cardiology, Hospital Universitario Puerta de Hierro, IDIPHISA, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Domínguez Rodríguez, MD, PhD

CONTACT

+34 91 1916000; fdominguezr@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The analysis of the cardiac magnetic resonance imaging will be performed by evaluators blinded to the treatment and the timing of the imaging.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: April 28, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After study scientific publication
• Access Criteria: Under request to Study Chair

Locations

ES (1)