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New treatment option for Cardiomyopathies
Official title CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
ClinicalTrials.gov ID: NCT06158698
What this study is testing
What is Colchicine?
Colchicine is an investigational medicine, given as an once-daily, being studied as a potential treatment for cardiomyopathies.
Also referred to as Treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Trial and Registry:
- Males and females with Infl-CMP associated with VA (including high PVC burden), reduced LVEF, or significantly increased levels of natriuretic...
- 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...
- Presence of any of the following characteristics and if symptoms have been present for more than 1 month:
You likely can't join if
- Registry:
- 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...
- 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...
- Previous history of cardiac surgery for instance correction of congenital heart disease or a valve repair/replacement
See the full eligibility criteria
Who can join
- Trial and Registry:
- 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...
- 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...
What rules you out
- Registry:
- 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,
- 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...
- 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, 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...
- 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...
- 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,
- 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...
- 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, 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...
- 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...
- Women with childbearing potential (this exclusion criterion is due to insufficient human information regarding the embryofoetal risk with colchicine)
- 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)
- Women during breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Campania, Italy
- Bologna, Emilia-Romagna, Italy
- Trieste, Friuli Venezia Giulia, Italy
- Udine, Friuli Venezia Giulia, Italy
- Rome, Lazio, Italy
- Milan, Lombardy, Italy
- Turin, Piedmont, Italy
- Ancona, The Marches, Italy
- Arezzo, Tuscany, Italy
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Campania, Italy; Bologna, Emilia-Romagna, Italy; Trieste, Friuli Venezia Giulia, Italy; Udine, Friuli Venezia Giulia, Italy; Rome, Lazio, Italy; Milan, Lombardy, Italy and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.