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Common painkiller ibuprofen tested as treatment for heart inflammation

NCT ID NCT06686862

Disease control Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This clinical trial is testing whether a 3-week course of ibuprofen can reduce heart scarring better than standard acetaminophen in people hospitalized with acute myocarditis (heart muscle inflammation). The study will enroll 150 adults with mild cases (normal heart pumping function) and use MRI scans to measure inflammation and scarring over 6 months. If successful, ibuprofen could become a simple, low-cost treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ibuprofen
What this could lead to
If it works, this could provide a simple, widely available treatment to reduce heart scarring in acute myocarditis.
What could go wrong
This is a relatively small Phase 3 trial (150 people) and uses an open-label design, which can introduce bias. Ibuprofen may not outperform acetaminophen, and long-term benefits are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

acute myocarditis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myocarditis acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario Puerta de Hierro-Majadahonda

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

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