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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
Les Hopitaux De Chartres Le Coudray France
Institut Des Neurosciences De La Timone Marseille France
Centre Hospitalier De Haguenau Haguenau France
Centre Hospitalier D Avignon Avignon France
Centre Hospitalier Saint Joseph Saint Luc Lyon France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier D Auxerre Auxerre France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Cbj doxhdrmffcaqgg Epagny Metz Tessy France
Crmxoq Hqytjnwdlfa Reydfume Uxyhchgiuvstp Dl Tiftr Tours France
Cnmszt Hjjkzxhkjqn Rgutmunl Dvctmmhytreiht Angers France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
16.07.2024

Trial locations

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.

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 ID:
2024-514610-13-00
Protocol code:
APHP211429
NCT ID:
NCT05855746
Trial Phase:
Therapeutic confirmatory (Phase III)

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