Phase 3 Cardiomyopathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Symptoms began 28 days ago or less
• The condition first appeared with chest pain, signs of heart failure, and/or palpitations
• A blood test result called troponin was above the normal upper limit at any point between hospital admission and enrolment in the trial
• A heart scan using contrast-enhanced Cardiac MRI (a special imaging test) has confirmed the diagnosis of myocarditis, using established diagnostic guidelines
• For people over 40 years old who have one or more heart disease risk factors (such as high blood pressure, smoking, high cholesterol, diabetes, or a personal or family history of heart artery disease), a scan or procedure has ruled out blocked heart arteries
• Women of childbearing age who are using an effective form of contraception throughout the treatment period and for one month after it ends
• Men who agree to use effective contraception throughout the treatment period and for one month after it ends
• People enrolled in the French national health insurance system ("sécurité sociale")
• People who have given written consent to participate

Who may not be able to join:

• People currently in severe heart failure requiring medication to support heart or blood pressure function (though people who stopped such medication more than 24 hours ago may still be considered)
• People whose myocarditis has been identified as a specific type called giant cell myocarditis or eosinophilic myocarditis
• People who have had a heart attack or who are known to have a significant blockage (more than 50%) in a heart artery
• People whose heart condition is caused by toxic substances
• People with an active long-term inflammatory disease, a chronic active infection, or a cancer that is currently progressing
• People who have had a severe widespread infection (sepsis) within the last 7 days
• People with a known allergy or sensitivity to the trial medication colchicine, or to any of its ingredients — including lactose, sucrose, microcrystalline cellulose, colloidal silica, magnesium stearate, or certain colourants (E127, Dual Red 40)
• People who cannot undergo a Cardiac MRI for any reason — including claustrophobia, metal fragments in the eyes, certain surgical clips in the brain or major blood vessels, cochlear implants, any implant held in place by a magnet, or a known allergy to the contrast dye used in the scan; people with an implanted heart device such as a defibrillator or pacemaker are also excluded
• People who are already taking corticosteroids, anti-inflammatory medications (NSAIDs), high-dose aspirin, or immune-suppressing drugs on an ongoing basis
• People diagnosed with sarcoidosis
• People with severe liver disease (classified as Child-Pugh C) or significantly reduced kidney function (confirm with trial site for exact threshold)
• People whose recent blood tests show low levels of red blood cells, white blood cells, or platelets (within 7 days before enrolment)
• People with significant ongoing digestive problems, such as chronic diarrhoea, uncontrolled ulcerative colitis, or active Crohn's disease
• People with a weakened immune system or a condition affecting bone marrow function
• People with a blood or bone marrow disorder (haemopathy)
• People whose recent blood tests show an elevated level of a specific type of white blood cell called eosinophils (above a certain level within 7 days before enrolment)
• Women who are pregnant or breastfeeding
• People who have taken part in another clinical trial or received an experimental drug within the 30 days before joining this trial
• People currently taking certain medications that interact with colchicine — including some antibiotics (such as azithromycin, clarithromycin, erythromycin, and others), cyclosporine, verapamil, certain HIV or hepatitis medications, strong antifungal drugs, blood thinners called vitamin K antagonists, and other specified drugs (confirm the full list with the trial site)
• People who are under a legal guardianship or protection order

Important: Always verify eligibility with the trial site directly before applying.