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Study on Colchicine for Reducing Heart Damage in Patients with Acute Myocarditis

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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 colchicine in patients who have been diagnosed with acute myocarditis. Acute myocarditis is a condition where the heart muscle becomes inflamed, often leading to symptoms like chest pain, heart failure, or palpitations. The study aims to see if colchicine can help reduce the damage to the heart muscle as seen on a special type of heart scan called Cardiac Magnetic Resonance (CMR) and improve overall heart health outcomes.

Participants in the study will receive either colchicine or a placebo, which is a substance with no active medication. The study will last for about six months, during which time the effects of colchicine on heart health will be closely monitored. This includes looking at changes in heart muscle damage and any heart-related symptoms or events that occur during the study period. The goal is to determine if colchicine can effectively reduce heart inflammation and improve the condition of patients with acute myocarditis.

Throughout the study, various health markers will be assessed, such as heart function and any side effects related to colchicine. The study will also track any serious health events, like heart failure or the need for heart-related medical procedures. By the end of the study, researchers hope to gather valuable information on whether colchicine can be a beneficial treatment for those suffering from acute myocarditis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, symptom onset, and diagnostic confirmation of acute myocarditis through cardiac magnetic resonance imaging (CMR).

  2. Step 2

    Initial assessment

    An initial assessment is conducted, which includes a review of medical history and current symptoms. Baseline measurements such as troponin levels and other serum biomarkers are taken.

  3. Step 3

    Medication administration

    Participants receive either colchicine or a placebo. The medication is administered orally in the form of a 1 mg tablet. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Follow-up assessments

    Follow-up assessments occur at specified intervals to monitor the participant's health and response to the medication. These assessments include cardiac magnetic resonance imaging (CMR) to evaluate myocardial damage and other clinical outcomes.

  5. Step 5

    Monitoring for side effects

    Participants are monitored for any side effects related to the medication, such as diarrhea, nausea, or myelotoxicity. Renal function is also assessed during hospitalization and at 6 months.

  6. Step 6

    Final evaluation

    A final evaluation is conducted at 6 months to assess the extent of late gadolinium enhancement on CMR and any composite clinical outcomes. This includes checking for heart failure, recurrence of myocarditis, or other significant events.

  7. Step 7

    Long-term follow-up

    Participants may be followed up for up to 1 year to evaluate the long-term efficacy of colchicine compared to placebo. This includes monitoring for any cardiovascular events or changes in cardiac function.

Who can join the trial?

10 criteria

  • Must be between 18 and 65 years old.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.
  • Symptoms must have started 21 days ago or less.
  • Must have chest pain, symptoms of heart failure, or palpitations (feeling of a fast or irregular heartbeat).
  • Troponin levels must be higher than the 99th percentile of the reference value. Troponins are proteins released when the heart muscle is damaged.
  • Myocarditis diagnosis must be confirmed by Cardiac Magnetic Resonance (CMR) imaging using the Lake Louise criteria from 2009 or later. CMR is a type of heart scan.
  • No signs of ischemic heart disease, which is a condition where the heart doesn't get enough blood. This must be checked by coronary angiography or coronary computed tomography angiography for patients over 40 with one or more risk factors like high blood pressure, smoking, high cholesterol, diabetes, or a personal or family history of heart disease.
  • Women of child-bearing age must use an effective contraception method during the treatment and for 1 month after, as determined by the study investigator.
  • Men must agree to use effective contraception during the treatment and for 1 month after.
  • Must be affiliated with the French Health Care System, known as "sécurité sociale."

Who cannot join the trial?

4 criteria

  • Patients who do not have a confirmed diagnosis of acute myocarditis on Cardiac magnetic resonance imaging. Acute myocarditis is a condition where the heart muscle becomes inflamed.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not able to provide informed consent or are considered part of a vulnerable population.
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Investigated drugs

Colchicine is a medication being studied in this trial for its potential to reduce inflammation in patients with acute myocarditis. The trial aims to see if colchicine can decrease the amount of heart muscle damage, as observed through cardiac imaging, and improve clinical outcomes over a period of six months.

What is already known about the treatment

Colchicine – Colchicine is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in treating acute myocarditis, a condition characterized by inflammation of the heart muscle. The main therapeutic indication for colchicine in this context is to reduce myocardial inflammation and improve clinical outcomes. At the molecular level, colchicine works by inhibiting microtubule polymerization, which reduces the activity of inflammatory cells. It is classified as an anti-inflammatory medication.

Investigated diseases

Acute Myocarditis – Acute myocarditis is an inflammation of the heart muscle, often caused by viral infections. It can lead to symptoms such as chest pain, fatigue, and shortness of breath. The inflammation can disrupt the heart's electrical system, causing arrhythmias or irregular heartbeats. Over time, the heart muscle may weaken, affecting its ability to pump blood effectively. This condition can develop suddenly and may resolve on its own or progress to more severe heart issues. Monitoring and supportive care are often necessary to manage symptoms and prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514610-13-00Protocol codeAPHP211429Estimated enrolment300 patientsSponsorAssistance Publique Hopitaux De Paris

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