Actively Recruiting
Colchicine Versus Placebo in Acute Myocarditis Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-25
300
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
H
Hospices Civils de Lyon
Collaborating Sponsor
AI-Summary
What this Trial Is About
Myocarditis is an inflammatory disease of the heart, mostly caused by viruses. Patients with acute myocarditis are exposed to several complications: recurrence, ventricular arrhythmias (from 5 to 30%), heart failure (5-10%), death or heart transplantation (\< 4%). To date, there is no specific treatment for myocarditis. Patient management only focuses upon empirical optimal care of arrhythmia and heart failure. There is a strong rationale for using colchicine in acute myocarditis: * the IL1 (Interleukin1) pathway plays a detrimental role in acute myocarditis. NLRP3 (NOD-like receptor family, pyrin domain containing 3) inflammasome assembly, and subsequent IL-1beta production, are profoundly inhibited by colchicine. * colchicine has been shown to improve cardiac outcomes in inflammatory cardiac disorders, including pericarditis, coronary artery disease, and post pericardiotomy syndrome. * In murine model of CVB3-induced myocarditis (coxsackievirus B3), colchicine improved myocarditis through reduction of NLRP3 activity. * Small case series with improvement of left ejection fraction in myocarditis following low-dose colchicine in addition to conventional heart failure therapy have been reported. With its pleiotropic anti-inflammatory effect in the pro-inflammatory cascade, reducing the myocardial damage and cell death induced during myocarditis, colchicine has the potential to reduce the risk of heart failure and ventricular arrhythmias. Finally, colchicine is a drug widely available, at low cost, and has a long and well-known safety record.
CONDITIONS
Official Title
Colchicine Versus Placebo in Acute Myocarditis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptom onset within 28 days or less
- Myocarditis presenting with chest pain, heart failure symptoms, or palpitations
- Troponin levels above the 99th percentile at any time between admission and inclusion
- Myocarditis diagnosis confirmed by Contrast-Enhanced Cardiac Magnetic Resonance according to Lake Louise criteria
- No evidence of ischemic heart disease for patients over 40 with cardiovascular risk factors
- Women of child-bearing age must use effective contraception during treatment and one month after
- Men must agree to use effective contraception during treatment and one month after
- Participant must be affiliated with the French Health Care System
- Written informed consent obtained
You will not qualify if you...
- Cardiogenic shock requiring inotropes or vasopressors (unless discontinued for more than 24 hours)
- Giant cell or eosinophilic myocarditis
- Acute coronary syndrome or known coronary stenosis greater than 50%
- Toxic cardiomyopathy
- Active chronic inflammatory disease, chronic active infection, or evolving cancer
- Recent severe sepsis within 7 days
- Hypersensitivity to colchicine or any excipients
- Contraindications to Cardiac Magnetic Resonance or contrast agents
- Presence of implantable cardioverter-defibrillator or pacemaker
- Chronic treatment with corticosteroids, NSAIDs, high-dose aspirin, or immunosuppressants
- Sarcoidosis
- Severe liver disease (Child Pugh C) or severe kidney dysfunction (GFR ≤30 ml/min)
- Cytopenia with specified low blood counts within 7 days before inclusion
- Major digestive disorders such as chronic diarrhea or uncontrolled inflammatory bowel disease
- Immunosuppression or spinal cord aplasia
- Hemopathy
- High eosinophil count (greater than 0.5 G/L)
- Pregnant or nursing women
- Participation in another investigational drug trial within 30 days before randomization
- Use of medications that interact with colchicine
- Under legal protection such as guardianship or trusteeship
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Unité de Soins Intensifs Cardiologiques - Hôpital Cardiovasculaire Louis Pradel
Bron, France, 69029
Actively Recruiting
2
Institut de Cardiologie - APHP Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
Research Team
T
Thomas BOCHATON
CONTACT
J
Julia CANTERINI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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