Project Details
Projekt
Colchicine for the treatment of chronic inflammatory cardiomyopathy
Applicant
Professor Dr. Carsten Tschöpe
Subject Area
Cardiology, Angiology
Term
since 2022
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 464108923
Inflammatory cardiomyopathy (DCMi) is a predominantly acquired heart disease that can progress to dilated cardiomyopathy (DCM), associated with poor prognosis if not treated. Currently, no specific treatment exists. Immunosuppressive therapies can exert beneficial effects in chronic, virus-negative DCMi. The effectiveness of immunosuppressive interventions with cortisone is limited, carries the risk of virus activation and is often associated with side effects. Safer and more specific intervention is still unavailable. In this context, the anti-inflammatory agent colchicine, which has traditionally been used to treat gout, has been shown to be beneficial in percarditis, and even in COVID-19. The results of our own animal studies confirm favorable effects in the mouse myocarditis model, whereby the inflammasome-3 in particular was inhibited. Colchicine is the only selective inflammsome-3 blocking agent available. OLdTIMer is a feasibility study on colchicine in patients with lymphocytic DCMi (n = 80) to check whether the patients can safely tolerate the medication and whether they have positive effects on cardiac function and inflammation. It is designed as a randomized, double-blind, placebo-controlled study with endpoints on cardiac function, quality of life, cardiac inflammation and safety. The effects are monitored by myocardial biopsies and magnetic resonance tomography (MRI). Male or female 18-75 year old patients with a cardiac ejection fraction (EF <49%) who meet the inclusion and exclusion criteria are considered eligible. Four study centers will take part in the study (Univ-Halle, Univ, - Greifswald, Berlin: Charite; DHZB). The study participants shall receive a twice-daily dose of 0.5 mg colchicine or placebo for six months. The primary study endpoint is improvement of EF assessed via CMR imaging. The secondary endpoints include improvement of quality of life, functional capacity, CMR-proven and biopsy-proven reduction of the cardiac inflammatory status and reduction of hospitalization rate. Safety measures include adverse and serious adverse events assessment together with regular follow-up of blood picture, kidney function, liver function, electrolyte balance and several biochemical safety markers including serum troponin-T, CK-MB and NT-proBNP. During the course of the study, seven visits shall take place to assess the patients-safety as well as the study endpoints. OLdTIMer will clarify whether colchicine has the potential to treat DCMi. If yes, the feasibility study results and experience will form the basis for deciding the duration of treatment, monitoring method (e.g. CMR or biopsy), optimal end-points and sample size for a large-scale phase II/III study.
DFG Programme
Clinical Trials
