Colchicine treatment for patients with acute myocarditis
Official title: Colchicine Versus Placebo in Acute Myocarditis Patients to Reduce Late Gadolinium Enhancement Mass on Cardiac Magnetic Resonance and the Risk of Clinical Outcomes: The ARGO Trial
Run by Assistance Publique - Hôpitaux de Paris · NCT05855746 · Data updated 2026-11-12
This study is testing if colchicine can help hospitalized patients with acute myocarditis feel better and improve their heart health compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Bron and 1 other locations) |
| Status | Recruiting |
| Started | July 16, 2024 |
| Main results expected | January 16, 2028 |
| Study ends | July 16, 2028 |
| Registry record updated | February 25, 2026 |
| Trial ID | NCT05855746 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with acute myocarditis symptoms that began within the last 21 days and who meet specific diagnostic criteria.
✕Probably not a fit
Patients with ischemic heart disease or those who do not meet the inclusion criteria will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III clinical trial investigates the efficacy of colchicine compared to a placebo in patients diagnosed with acute myocarditis. The study involves a randomized, double-blind, multicenter approach where participants receive either colchicine or a placebo alongside standard care. Eligible patients will be hospitalized with symptoms of myocarditis and will be monitored for six months following treatment. The trial aims to assess whether colchicine can improve cardiac outcomes by targeting inflammation associated with the condition.
Why it matters
Potential benefit: If successful, this treatment could provide a specific therapeutic option for patients suffering from acute myocarditis, potentially reducing complications and improving recovery.
How similar studies have gone: Previous studies have shown colchicine to be effective in other inflammatory cardiac conditions, suggesting potential success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptom onset of 28 days or less, * Myocarditis initially presenting with chest pain and/or Heart failure symptoms and/or palpitations * Troponins superior to 99 percentile of reference value, at any time between admission and inclusion * Myocarditis diagnostic confirmation (by Contrast-Enhanced Cardiac Magnetic Resonance (CMR), according to the Lake Louise criteria (2009 or later), * No evidence for ischemic heart disease on coronary angiography or coronary computed tomography angiography for patients with age superior to 40-year-old with one or more cardiovascular risk factor (hypertension, smoking, hypercholesterolemia, diabetes, personal or family history of coronary artery disease), * Woman of child-bearing age with an effective contraception method according to the investigator for the duration of treatment and one month after, * Man accepting effective contraception for the duration of treatment and one month after, * Participant with affiliation to the French Health Care System "sécurité sociale", * Written informed consent of the patient obtained. Exclusion Criteria: * Cardiogenic shock requiring inotropes or vasopressors (patients with inotropes discontinued for more than 24 hours can be enrolled) * Giant cell myocarditis or eosinophilic myocarditis * Acute coronary syndrome or known coronary stenosis superior to 50% * Toxic cardiomyopathy * Active chronic inflammatory disease, chronic active infection, evolving cancer * A recent severe sepsis (7 days) * Hypersensitivity to Investgational Medical Product's active substances (colchicine) or to any of the excipients (including lactose, sucrose, microcrystalline cellulose, colloidal silica, magnesium stearate, colourants : E127, Dual Red 40 ) * Any known contra-indication to CMR or associated contract products (claustrophobia; intra-ocular metal foreign bodies, clips such as cerebral, carotid, or aortic aneurysm, cochlear implants, any implant held in by magnet, history of hypersensitivity to gadoteric acid or to gadolinium contrast agents or to meglumine). Patients with an implantable cardioverter-defibrillator (ICD) or pacemaker (PM) are also excluded due to the risk of imaging artifacts, which may compromise the reliable quantification of late gadolinium enhancement (LGE). * Chronic treatment with corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or high-dose aspirin or immunosuppressant. * Sarcoidosis * Severe liver (Child Pugh C) or known renal dysfunction (known Glomerular Filtration Rate (GFR) less or equal to 30 ml/min according Cockroft), * Cytopenia : hemoglobin less than 100 grams/L, white blood cell count less than 3.0 G/L, platelet count less than 100 G/L between admission and inclusion (within 7 days) * Major digestive disorders (chronic diarrhea, inflammatory disease of the digestive tract as uncontrolled ulcerative colitis or active Crohn disease) * Immunosuppression, spinal cord aplasia * Hemopathy * Hypereosinophilia more than 0.5 G/L between admission and inclusion * Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive local laboratory test, * Administration of any investigational drug or participation in another interventional trial, within 30 days before randomization, * Participant under treatment having an interaction with colchicine \[macrolides (telithromycin, azithromycin, clarithromycin, dirithromycin, erythromycin, josamycin, midecamycin, roxithromycin), pristinamycin,, cyclosporine, verapamil, all protease inhibitors, telaprevir, CYP3A4 powerful inhibitors, azole antifungals, vitamin K antagonists\] * Participant under legal protection: under guardianship (trusteeship or curatorship)
Where it's running
-
Unité de Soins Intensifs Cardiologiques - Hôpital Cardiovasculaire Louis Pradel
Bron, France Recruiting -
Institut de Cardiologie - APHP Pitié Salpêtrière
Paris, France Recruiting
Study contacts
- Study coordinator: Thomas BOCHATON
- Email: thomas.bochaton@chu-lyon.fr
- Phone: +33472357549
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Treatment of acute myocarditis with corticosteroids
This study is testing if a corticosteroid treatment can help people with acute myocarditis and heart function issues feel better compared to standard care.
-
Heart@Home: Safe, at-home care for people with acute heart problems compared with hospital care
This trial tests whether hospital-level care at home can safely and effectively treat adults with acute heart conditions who would normally be in the hospital.
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National platform for studying inflammatory heart disease
This study is trying to gather information from patients with suspected heart inflammation to better understand their symptoms, treatment, and the factors that affect their condition.
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Using Spectral CT to Diagnose Myocarditis in Patients with Chest Pain
This study is testing if a new type of CT scan can help doctors better diagnose myocarditis and other causes of chest pain in patients who might not have heart disease.
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Ibuprofen versus acetaminophen for uncomplicated acute myocarditis
This trial will test whether a 3-week ibuprofen taper compared with acetaminophen helps adults hospitalized with uncomplicated acute myocarditis (LVEF ≥50%) reduce heart scarring seen on cardiac MRI at 6 months.
-
National surveillance of myocarditis and pericarditis after mRNA COVID-19 vaccination
This study is trying to see how mRNA COVID-19 vaccines might affect heart health by following patients who develop heart inflammation after getting vaccinated.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.