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Single-blinded randomized investigator-initiated controlled trial to assess the efficacy of colchicine to treat patients with cardiomyopathy with myocarditis (chronic inflammatory cardiomyopathy) – Trial and Registry to study the role of genotype environment interaction in Chronic myocarditis and inflammatory cardiomyopathies with ventricular pro-arrhythmic and heart failure phenotypes (PNRR-MAD-2022-12376225)
EU CTIS ID: 2024-517945-14-00
What this study is testing
The primary objective is to assess the efficacy of colchicine compared to placebo after 6 months of treatment. It is expected that among patients on optimal medical therapy (OMT) plus colchicine a larger proportion of patients will reach the primary endpoint with respect to the placebo arm.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 are present lasting for more than 1 month: a. Mono-morphic or polymorphic PVC burden of ≥500 in 24 hours, or NSVTs (defined as ≥3 consecutive beats at a rate >100 beats per minute lasting <30 seconds) or evidence of sustained ventricular tachycardias (SVT) b. Reduced LVEF on echocardiogram (<50%) or on CMRI (<60%) c. 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 d. 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
You likely can't join if
- Proven history of myocardial infarction with evidence of ischemic scar on echocardiogram or CMRI
- Current symptomatic atrial arrhythmias (including persistent atrial fibrillation) associated with LV dysfunction
- Advance heart failure (NYHA III or need for inotropes including levosimendan), or recurrent VA despite previous catheter ablation
- Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful (i.e. cardiac sarcoidosis)
- Patients already on chronic immunosuppressive therapies (including colchicine) or in whom immunosuppressive therapy is deemed necessary
- Contraindication to colchicine, including allergies to this medication and its excipients (i.e., lactose and sucrose)
See the full eligibility criteria
Who can join
- 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 are present lasting for more than 1 month: a. Mono-morphic or polymorphic PVC burden of ≥500 in 24 hours, or NSVTs (defined as ≥3 consecutive beats at a rate >100 beats per minute lasting <30 seconds) or evidence of sustained ventricular tachycardias (SVT) b. Reduced LVEF on echocardiogram (<50%) or on CMRI (<60%) c. 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 d. 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
What rules you out
- Proven history of myocardial infarction with evidence of ischemic scar on echocardiogram or CMRI
- Current symptomatic atrial arrhythmias (including persistent atrial fibrillation) associated with LV dysfunction
- Advance heart failure (NYHA III or need for inotropes including levosimendan), or recurrent VA despite previous catheter ablation
- Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful (i.e. cardiac sarcoidosis)
- Patients already on chronic immunosuppressive therapies (including colchicine) or in whom immunosuppressive therapy is deemed necessary
- Contraindication to colchicine, including allergies to this medication and its excipients (i.e., lactose and sucrose)
- 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.
- Severe gastrointestinal insufficiency (for instance, malabsorption syndrome, severe chronic diarrhea)
- Significant flow-limiting coronary artery disease (stenosis above 50%) on invasive coronary angiography or computed tomography (CT) coronary angiography
- Cardiomyopathy attributed to toxins such as alcohol and illicit drugs, or to specific causes (i.e. amyloidosis or hypertrophic cardiomyopathy)
- 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.
- Previous history of cardiac surgery for instance correction of congenital heart disease or a valve repair/replacement
- Known chronic infective disease, such as HIV infection or tuberculosis
- Participants involved in another clinical trial
- 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
- Women with childbearing potential
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.