Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06686862

Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

Led by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III · Updated on 2026-02-13

150

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

Sponsors

F

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Lead Sponsor

F

Fundación Investigación Biomédica Puerta de Hierro Majadahonda

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Hospitalized for confirmed acute myocarditis with left ventricular ejection fraction greater than 50%
  • Elevated troponin I or T levels at least three times above the upper limit of normal
  • No acute heart failure present
  • No ischemic heart disease as confirmed by coronary angiography or coronary CT scan (for those over 40 years old)
  • Meets diagnostic criteria for myocarditis by cardiac magnetic resonance imaging (Lake Louise 2018 update)
Not Eligible

You will not qualify if you...

  • Kidney disease stage 3b, 4, or 5 with creatinine clearance less than 45 ml/min/1.73 m2
  • Severe liver failure (Child-Pugh class C)
  • Poorly controlled high blood pressure (systolic pressure repeatedly over 140 mmHg)
  • Diagnosed acute pericarditis
  • Moderate or severe pericardial fluid accumulation (more than 10 mm)
  • Allergic to NSAIDs or used NSAIDs in the last 7 days
  • Cannot undergo MRI
  • Currently participating in another clinical trial
  • Pregnant, breastfeeding, or women of childbearing age not using contraception
  • Any condition that the investigator believes would interfere with participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, Spain, 28222

Actively Recruiting

Loading map...

Research Team

F

Fernando Domínguez Rodríguez, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis | DecenTrialz