Phase 3 Cardiomyopathy Trial, Recruiting

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

Who might be able to join this trial:

• You are 18 years of age or older
• You have been formally diagnosed with a condition called ATTR cardiomyopathy (a disease where a protein called TTR builds up in the heart), either the inherited type or the age-related type
• Your diagnosis has been confirmed through a heart tissue sample, a specific type of nuclear medicine heart scan, or a combination of scan results and blood/urine tests showing the TTR protein is involved
• An ultrasound of your heart (echocardiogram) shows that the wall between the two sides of your heart measures 12mm or thicker
• You have ongoing heart failure (ranging from mild to severe symptoms) and have either been hospitalised for it at least once, or have had symptoms such as breathlessness, leg swelling, or fluid build-up that required water tablet (diuretic) treatment
• Your heart medications have been at a stable dose (no more than 50% change, no new types added) for at least 4 weeks before joining the study — except for water tablets (diuretics)
• You are able to walk more than 50 metres during a 6-minute walking test at your screening visit

Who may not be able to join:

• You have a known allergy or sensitivity to the study treatment or similar products
• You have previously taken part in a clinical trial involving an investigational ATTR-reducing or ATTR gene-editing treatment
• Your liver test results show bilirubin levels more than 3 times the normal upper limit at screening
• You have a different type of amyloidosis (not ATTR), multiple myeloma, or a condition where amyloid affects the brain and spinal cord lining
• Your heart failure is mainly caused by something other than ATTR cardiomyopathy, such as high blood pressure, valve disease, or blocked heart arteries (in the opinion of the doctor)
• You are currently in hospital or were hospitalised within the 14 days before your screening visit
• You are currently taking medication to artificially strengthen your heart's pumping action (positive inotropic drugs)
• You have a severe, uncorrected problem with a valve on the left side of your heart that significantly affects blood flow
• You have had a heart attack, unstable chest pain, stroke, mini-stroke, heart procedure, heart valve repair, or major surgery within 60 days before screening
• You have had an organ transplant in the past, or one is planned during the study period
• Your heart's pumping function (ejection fraction) is below 30%, as measured by a heart ultrasound
• You have had a cancer diagnosis (other than certain low-risk or skin cancers, or stable prostate cancer — confirm with trial site) within the 3 years before screening
• You have very advanced kidney disease, including being on dialysis or having a kidney filtration rate below 15 mL/min/1.73m²

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