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Study on Ibuprofen vs. Conventional Treatment for Patients with Acute Myocarditis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Ibuprofen in patients with a heart condition known as Acute Myocarditis. Acute Myocarditis is an inflammation of the heart muscle that can affect the heart's ability to pump blood effectively. The study will compare the use of Ibuprofen, a common non-steroidal anti-inflammatory drug (NSAID), with conventional treatment using another pain reliever, Paracetamol.

The purpose of the study is to determine if Ibuprofen is more effective than Paracetamol in treating Acute Myocarditis, particularly in patients whose heart is still functioning well. Participants will be given either Ibuprofen or Paracetamol for a period of three weeks. The study will monitor changes in the heart over a six-month period using a special imaging technique called Cardiac Magnetic Resonance (CMR), which helps visualize the heart's structure and function.

Throughout the study, participants will undergo regular check-ups to assess their heart health and any changes in their condition. The goal is to see if Ibuprofen can reduce the inflammation in the heart more effectively than the conventional treatment. This research aims to provide valuable insights into better treatment options for those affected by Acute Myocarditis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the inclusion criteria: being 18 years or older, hospitalized for confirmed acute myocarditis with a left ventricular ejection fraction of 50% or more, absence of acute heart failure, exclusion of ischemic heart disease, and ability to provide informed consent.

  2. Step 2

    Initial assessment

    An initial cardiac magnetic resonance imaging (MRI) is performed to confirm the diagnosis of acute myocarditis and to establish a baseline for late gadolinium enhancement, which is a measure used to assess heart tissue damage.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to one of two treatment groups. One group receives ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), administered orally. The dosage and frequency are determined by the study protocol and are taken for a duration of 3 weeks.

    The other group receives conventional treatment with analgesics, specifically paracetamol, also administered orally, following the same duration of 3 weeks.

  4. Step 4

    Follow-up assessments

    Participants undergo regular follow-up assessments to monitor their health status and any changes in symptoms. These assessments are scheduled according to the study protocol.

  5. Step 5

    Final assessment

    At 6 months after the initial diagnosis, a follow-up cardiac MRI is conducted to measure changes in late gadolinium enhancement compared to the baseline. This helps to evaluate the effectiveness of the treatment in reducing heart tissue damage.

Who can join the trial?

7 criteria

  • Must be 18 years or older.
  • Must be hospitalized for confirmed acute myocarditis, which is an inflammation of the heart muscle.
  • Must have a left ventricular ejection fraction of 50% or higher. This is a measure of how well the heart is pumping blood.
  • Must not have acute heart failure, which is when the heart suddenly can't pump enough blood to meet the body's needs.
  • Must not have ischemic heart disease, which is a condition caused by narrowed heart arteries.
  • Must meet the diagnostic criteria for myocarditis using a special heart scan called cardiac magnetic resonance imaging.
  • Must be able to provide informed consent, meaning you understand the study and agree to participate.

Who cannot join the trial?

8 criteria

  • Patients with other heart conditions that are not related to acute myocarditis cannot participate. Acute myocarditis is a condition where the heart muscle becomes inflamed.
  • Individuals who have had a recent heart attack or other serious heart events are excluded.
  • Patients with severe kidney or liver disease are not eligible.
  • People who are currently taking medications that might interfere with the study treatment cannot join.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Individuals with a history of allergic reactions to ibuprofen or paracetamol are excluded.
  • Participants in another clinical trial at the same time are not eligible.
  • Anyone with a condition that the study doctors believe would make it unsafe for them to participate will be excluded.
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Investigated drugs

  • Ibuprofen

    is a non-steroidal anti-inflammatory drug (NSAID) used in this trial to see if it can help reduce inflammation in the heart muscle for patients with acute myocarditis. The study aims to determine if taking ibuprofen for three weeks can improve heart health by reducing certain markers seen in heart imaging tests.

  • Paracetamol

    is a common pain reliever and fever reducer used as a conventional treatment in this trial. It is being compared to ibuprofen to see which is more effective in managing symptoms and improving heart health in patients with acute myocarditis.

What is already known about the treatment

  • Ibuprofen

    Ibuprofen is typically administered orally in tablet form and is widely used as a non-steroidal anti-inflammatory drug (NSAID). It is currently well-established in medical practice and literature for its anti-inflammatory and pain-relieving properties. In the context of acute myocarditis, ibuprofen is being evaluated for its potential to reduce inflammation and improve heart function. It works by inhibiting enzymes called cyclooxygenases, which play a key role in the production of substances that cause inflammation and pain. Ibuprofen is classified as an NSAID and is commonly used to treat conditions involving pain and inflammation.

  • Paracetamol

    Paracetamol, also known as acetaminophen, is usually taken orally in tablet form and is a widely used analgesic and antipyretic. It is well-documented in medical literature for its effectiveness in relieving mild to moderate pain and reducing fever. In the treatment of acute myocarditis, paracetamol is used as part of conventional therapy to manage pain without the anti-inflammatory effects. Its mechanism of action is not fully understood, but it is believed to involve the inhibition of certain enzymes in the brain that help transmit pain signals. Paracetamol is classified as an analgesic and antipyretic.

Investigated diseases

Acute myocarditis – Acute myocarditis is an inflammation of the heart muscle, often caused by viral infections, autoimmune diseases, or exposure to certain toxins. It can lead to symptoms such as chest pain, fatigue, shortness of breath, and irregular heartbeats. The inflammation can disrupt the heart's ability to pump blood effectively, potentially causing fluid buildup in the lungs or other parts of the body. In some cases, the condition may resolve on its own, while in others, it can progress to more severe heart problems. The severity and progression of symptoms can vary widely among individuals. Monitoring and supportive care are often necessary to manage the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513803-15-00Estimated enrolment150 patientsSponsorCentro Nacional De Investigaciones Cardiovasculares Carlos III

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