Phase 3 Cardiomyopathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Men and women who have an inflammatory heart muscle disease linked to abnormal heart rhythms coming from the lower chambers, a weakened pumping function, or significantly raised levels of certain heart stress markers in the blood.
• People aged 18 years or older.
• People who have had a specialised heart scan (cardiac MRI or FDG-PET) showing signs of heart inflammation, taken within the past 3 months (for the treatment part of the trial) or within the past 12 months (for the observational registry part).
• People whose symptoms have been present for more than 1 month, and who also have one of the following: a high number of extra heartbeats from the lower chambers (3,000 or more in 24 hours), short runs of fast abnormal heart rhythms, or episodes of sustained fast abnormal heart rhythms.
• People whose heart pumping function is below normal on ultrasound or cardiac MRI.
• People with significantly elevated levels of certain heart stress proteins in the blood (NT-proBNP of 1,000 pg/mL or more, or BNP of 200 pg/mL or more).
• People with persistently raised heart injury markers (troponin) after at least 2 months, along with at least 1,000 extra heartbeats from the lower chambers in 24 hours.

Who may not be able to join:

• People with a confirmed history of a heart attack with scarring visible on imaging.
• People with significant blockages (more than 50%) in the arteries supplying the heart, found on coronary artery testing.
• People whose heart muscle disease is caused by alcohol, illicit drugs, or specific conditions such as amyloidosis or hypertrophic cardiomyopathy.
• People with a known systemic autoimmune disease, except in certain cases where there is also a family history of heart muscle disease, heart inflammation, or abnormal heart rhythms and genetic testing confirms a specific result — those people may be eligible for the registry part only (confirm with trial site).
• People who have previously had heart surgery, such as repair of a heart defect present from birth or a heart valve procedure.
• People with a known long-term infectious disease, such as HIV or tuberculosis.
• People who have taken an investigational drug in another clinical trial within the past 30 days, or within 5 half-lives of that drug, whichever is the longer period.
• People with another serious illness or condition where life expectancy is estimated at less than 12 months, or where participation could pose a risk or affect the trial results, based on the investigator's assessment.
• Women of childbearing potential are not eligible for the treatment part of the trial, due to insufficient safety information about the study drug (colchicine) during pregnancy (confirm with trial site).
• People currently experiencing symptoms caused by irregular rhythms in the upper chambers of the heart (such as persistent atrial fibrillation) together with a weakened pumping function.
• People with advanced heart failure (classified as NYHA Class III or requiring certain heart-stimulating medications), or people who have had repeated abnormal heart rhythms despite previous catheter ablation treatment.
• People with a known systemic autoimmune condition or other conditions where immune-suppressing treatment is considered appropriate (such as cardiac sarcoidosis).
• People already taking long-term immune-suppressing medications, including colchicine, or for whom such treatment is considered necessary.
• People with a known allergy or sensitivity to colchicine or any of its ingredients (including lactose and sucrose).
• People with significantly reduced kidney function (eGFR below 30 ml/min/1.73m²).
• People with a known history of liver cirrhosis, or liver enzyme levels more than three times the upper limit of normal at the start of the trial.
• People with a high level of a particular type of white blood cell called eosinophils (more than 10% of white blood cells), or a known condition causing this.
• People with severe problems absorbing or processing food through the digestive system, such as malabsorption syndrome or severe ongoing diarrhoea.
• Women who are currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.