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Myocarditis AcutePhase 3INFLAMANCT06686862

Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

A Phase 3 study testing ibuprofen in people with Myocarditis Acute, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocarditis Acute
What is being tested?
ibuprofen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSpain
Study dates
28 Apr 2025to Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fernando Domínguez Rodríguez, MD, PhD contact

+34 91 1916000

fdominguezr@salud.madrid.org

Spain1 site, 1 recruiting

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Majadahonda, Madrid, 28222

    Fernando Domínguez Rodríguez, MD, PhD, +34 91 1916000, fdominguezr@salud.madrid.org

    Noemí Ramos López, nramosl@cnic.es

    Recruiting

Other trials in Spain

About this study

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

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.

Read the detailed description

The treatment for patients with uncomplicated myocarditis (left ventricular ejection fraction >50% without heart failure) is not currently well defined. Analgesic drugs are commonly used to manage pain. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) among analgesics is controversial due to potential harmful effects observed in animal models. However, NSAIDs are the standard treatment for pericarditis, even when it is associated with mild myocardial involvement. In patients with acute myocarditis and normal left ventricular ejection fraction, observational studies have suggested that NSAIDs may have a beneficial effect in reducing late gadolinium enhancement (LGE) measured in cardiac magnetic resonance (CMR), an important prognostic marker in this population.

We plan to conduct a prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of NSAIDs versus conventional analgesic treatment in patients with uncomplicated acute myocarditis and left ventricular ejection fraction ≥50%.

Approximately 150 patients will be randomized 1:1 to NSAID treatment (ibuprofen tapering schedule during 3 weeks) or conventional treatment (acetaminophen or metamizole in case of allergy until pain resolution) during hospital admission. Patients will be followed for a 12-month period. Baseline CMR will be performed at initial hospitalization for acute myocarditis and at 3 and 6 months.

The primary objective is to assess the utility of ibuprofen versus conventional treatment with analgesics in acute myocarditis with preserved LVEF, in terms of reducing LGE on CMR at 6-month follow-up compared to baseline.

Being tested
ibuprofen
Keywords
Nonsteroidal antiinflammatory agents, Magnetic Resonance Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ibuprofenDrug

    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.

Study groups in NCT06686862
Study groupRoleWhat they receive
IbuprofenExperimentalIbuprofen tapering schedule during 3 weeks.
Receives: Drug: ibuprofen
AcetaminophenNo interventionAcetaminophen or metamizole in case of allergy until pain resolution, according to routine clinical practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (9)

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

    Measured: 3 months

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

    Measured: 6 months

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

    Measured: 3 months

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

    Measured: 6 months

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

    Measured: 3 months

  6. Compare exercise capacity using METs (metabolic equivalent) in conventional treadmill exercise test at 3 months.

    Measured: 3 months

  7. Proportion of patients experiencing arrhythmias during treadmill exercise test at 3 months

    Measured: 3 months

  8. Proportion of patients from each group experiencing hospitalization due to recurrent myocarditis, heart failure, severe ventricular arrhythmias, or cardiovascular death at 12 months.

    Measured: 1 year

  9. Proportion of patients developing adverse events in each treatment group at 1 month

    Adverse events: severe adverse event, grade 3-4 adverse event, adverse reaction, special interest adverse event.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start28 Apr 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06686862
Sponsor's protocol ID
2024-513803-15-00
Other IDs
2024-513803-15-00
Acronym
INFLAMA
Status last verified
Feb 2025
First submitted
12 Nov 2024
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Under agreement, individual or aggregated patient data could be shared with other scientific groups for scientific projects. Data can be shared only for scientific purposes and in full compliance with Personal Data Protection requirements in the EU.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ibuprofen in people with Myocarditis Acute, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fernando Domínguez Rodríguez, MD, PhD (+34 91 1916000, fdominguezr@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in late gadolinium enhancement (measured in % relative to indexed myocardial mass) compared to baseline (CMR) at admission) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06686862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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