Phase 3 Trial to Evaluate Colchicine Treatment for Patients with Chronic Inflammatory Cardiomyopathy and Myocarditis

What this Trial Is About

Researchers are evaluating colchicine as a treatment for patients with chronic inflammatory cardiomyopathy Infl-CMP, a heart condition caused by inflammation of the heart muscle that can lead to dangerous heart rhythm problems and heart failure. This phase III trial also includes a registry to study the role of genetic factors in the disease. The trial aims to find out if colchicine can reduce inflammation and improve heart function compared to placebo, especially considering patients genetic backgrounds. In this randomized, single-blinded, multi-center trial, patients with Infl-CMP will receive colchicine at doses of 0.5 to 1 mg daily or placebo tablets for 6 months. The study includes patients with signs of heart inflammation confirmed by imaging tests like cardiac MRI or PET scans, along with specific heart rhythm abnormalities or reduced heart pumping ability. A prospective registry will follow additional patients to explore the impact of genetic testing on disease outcomes. Blood and tissue samples will also be studied to understand the underlying molecular mechanisms. Participants will undergo regular assessments over the 6-month treatment period, including imaging tests, heart rhythm monitoring, blood tests, and evaluations of symptoms and quality of life. Researchers will measure whether patients remain alive without disease worsening and look for improvements in heart imaging or arrhythmia burden. Safety monitoring and follow-up will continue through the trial, with results aimed at guiding future personalized treatments for Infl-CMP.

CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine