Tests colchicine in people with inflammatory heart muscle disease

Trial details

Who runs it

Niguarda Hospital

Trial code

NCT06158698

Record updated

20 April 2026

Original description

Two-parallel groups randomized, single-blinded, multi-center phase III controlled trial in patients with chronic inflammatory cardiomyopathy to assess the efficacy of colchicine and associated prospective registry to assess the prognostic value of positive genetic testing in this population.Read full original descriptionShow less

Single-blinded Randomized Investigator-initiated Controlled Trial to Assess the Efficacy of Colchicine to Treat Patients With Cardiomyopathy With Myocarditis (Chronic Inflammatory Cardiomyopathy)

Two-parallel groups randomized, single-blinded, multi-center phase III controlled trial in patients with chronic inflammatory cardiomyopathy to assess the efficacy of colchicine and associated prospective registry to assess the prognostic value of positive genetic testing in this population.

Inclusion: Males and females with Infl-CMP associated with VA (including high PVC burden), reduced LVEF, or significantly increased levels of natriuretic peptides; Patients of 18 years or older; Evidence of myocardial inflammation on CMRI (using 2018 Lake Louis criteria) or FDG-PET performed in the 3 months before randomization to be included in the trial OR in the last 12 months before for the registry; Presence of any of the following characteristics and if symptoms have been present for more than 1 month:; Mono-morphic or polymorphic PVC burden of ≥3000 in 24 hours, or NSVTs (defined as >3 more consecutive beat lasting <30 seconds) or evidence of sustained ventricular tachycardias (SVT); Reduced LVEF on echocardiogram (<50%) or on CMRI (<60%)-. Increased N-terminal pro-B-type natriuretic peptide (NT- proBNP) concentration of 1000 pg/mL or more, or a B-type natriuretic peptide (BNP) concentration of 200 pg/mL or more; Persistence of increased high-sensitivity troponin levels above the upper reference limit (URL) after at least 2 months from the first assessment and at least a mono-morphic or polymorphic PVC burden of ≥1000 in 24 hours.

Exclusion: Cardiomyopathy attributed to toxins such as alcohol and illicit drugs, or to specific causes (i.e. amyloidosis or hypertrophic cardiomyopathy); Previous history of cardiac surgery for instance correction of congenital heart disease or a valve repair/replacement; Participants involved in another clinical trial, defined by the participation in a clinical trial in which an investigational drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer; Cardiomyopathy attributed to toxins such as alcohol and illicit drugs, or to specific causes (i.e. amyloidosis or hypertrophic cardiomyopathy); Previous history of cardiac surgery for instance correction of congenital heart disease or a valve repair/replacement; Participants involved in another clinical trial, defined by the participation in a clinical trial in which an investigational drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer; Advance heart failure (NYHA III or need for inotropes including levosimendan), or recurrent VA despite previous catheter ablation,; Patients already on chronic immunosuppressive therapies (including colchicine) or in whom immunosuppressive therapy is deemed necessary; Proven history of myocardial infarction with evidence of ischemic scar on echocardiogram or CMRI,; Significant flow-limiting coronary artery disease (stenosis above 50%) on invasive coronary angiography or computed tomography (CT) coronary angiography,; Known systemic autoimmune disorder (the exception will be for patients with systemic autoimmune disease or isolated cardiac sarcoidosis with a family history of cardiomyopathy, myocarditis, or arrhythmias, where overlap between an autoimmune event and a genetic background can occur). These patients will undergo genetic tests. Patients with autoimmune systemic disorders and isolated cardiac sarcoidosis with positive genetic tests for MCVG will be included in the registry; Known chronic infective disease, such as HIV infection or tuberculosis; Any other significant disease or disorder which (expected life expectancy <12 months), in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial or the participant's ability to participate in the trial; Proven history of myocardial infarction with evidence of ischemic scar on echocardiogram or CMRI,; Significant flow-limiting coronary artery disease (stenosis above 50%) on invasive coronary angiography or computed tomography (CT) coronary angiography,; Known systemic autoimmune disorder (the exception will be for patients with systemic autoimmune disease or isolated cardiac sarcoidosis with a family history of cardiomyopathy, myocarditis, or arrhythmias, where overlap between an autoimmune event and a genetic background can occur). These patients will undergo genetic tests. Patients with autoimmune systemic disorders and isolated cardiac sarcoidosis with positive genetic tests for MCVG will be included in the registry; Known chronic infective disease, such as HIV infection or tuberculosis; Any other significant disease or disorder which (expected life expectancy <12 months), in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial or the participant's ability to participate in the trial; Current symptomatic atrial arrhythmias (including persistent atrial fibrillation) associated with LV dysfunction,; Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful (i.e. cardiac sarcoidosis),; Contraindication to colchicine, including allergies to this medication and its excipients (i.e., lactose and sucrose),; Severe gastrointestinal insufficiency (for instance, malabsorption syndrome, severe chronic diarrhea); Impaired renal function (eGFR<30 ml/min/1.73m2),; Known history of hepatic cirrhosis or transaminase levels at baseline > x3-fold the URL; Patients with peripheral eosinophilia (eosinophil count >10% of the leukocytes) or known hypereosinophilic syndrome at the time of randomization; Women with childbearing potential (this exclusion criterion is due to insufficient human information regarding the embryofoetal risk with colchicine); Women during breastfeeding.

ClinicalTrials.gov NCT06158698