Study to assess the efficacy of colchicine to treat patients with cardiomyopathy with chronic inflammatory cardiomyopathy and myocarditis.

Phase 1

• Conditions: Cardiomyopathy with myocarditis (chronic inflammatory cardiomyopathy); MedDRA version: 20.0Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2022-003912-99-IT
• Lead Sponsor: AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-20
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients of 18 years or older
2. 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.
3. 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 =3000 in 24 hours, or NSVTs (defined as >3 more consecutive beat 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Proven history of myocardial infarction with evidence of ischemic scar on echocardiogram or CMRI,
2. Significant flow-limiting coronary artery disease (stenosis above 50%) on invasive coronary angiography or computed tomography (CT) coronary angiography,
3. Cardiomyopathy attributed to toxins such as alcohol and illicit drugs, or to specific causes (i.e. amyloidosis or hypertrophic cardiomyopathy)
4. 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.
5. Previous history of cardiac surgery for instance correction of congenital heart disease or a valve repair/replacement
6. Known chronic infective disease, such as HIV infection or tuberculosis
7. Participants involved in another clinical trial;
8. Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) test measures (urine/blood) for women of 18-50 years of age; and breastfeeding women.
9. 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.
10. Current symptomatic atrial arrhythmias (including persistent atrial fibrillation) associated with LV dysfunction,
11.. Advance heart failure (NYHA III or need for inotropes including levosimendan), or recurrent VA despite previous catheter ablation,
12.. Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful (i.e. cardiac sarcoidosis),
13. Patients already on chronic immunosuppressive therapies (including colchicine) or in whom immunosuppressive therapy is deemed necessary
14. Contraindication to colchicine, including allergies to this medication and its excipients (i.e., lactose and sucrose),
15. Impaired renal function (eGFR<30 ml/min/1.73m2),
16. Known history of hepatic cirrhosis or transaminase levels at baseline > x3-fold the URL
17.Patients with peripheral eosinophilia (eosinophil count >10% of the leukocytes) or known hypereosinophilic syndrome at the time of randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified