Phase 4 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:

• People aged 18 to 90 years old at the time of signing the consent form
• People who have been diagnosed with ATTR-CM (a type of heart disease caused by abnormal protein deposits), confirmed by a specific scan (SPECT or SPECT/CT) or tissue biopsy done within the past 24 months
• People who are currently taking the medication tafamidis and have been taking it consistently for at least the past 3 months
• People whose heart failure symptoms are mild, rated as Class I or II on a standard medical scale (New York Heart Association classification)
• People whose kidneys are functioning at or above a certain level, as measured by a blood test called eGFR (confirm exact value with trial site)
• People whose blood levels of a heart stress marker called NT-proBNP fall within a specific range (confirm exact values with trial site)

Who may not be able to join:

• People who have previously had a liver or heart transplant, or for whom one is planned within the next 12 months
• People who currently use or plan to use a mechanical heart pump device (ventricular assist device)
• People who have an active cancer or another serious illness that is expected to shorten life expectancy to less than one year
• People whose heart failure is caused by blocked heart arteries (ischemic heart disease)
• People who have had a heart attack, heart surgery, or severe chest pain episode in the 90 days before the first study visit
• People who have a confirmed diagnosis of a different type of amyloidosis called light-chain amyloidosis
• People who are on dialysis or have significant kidney problems, as shown by a specific urine test result
• People who have had major surgery in the 90 days before the first study visit
• People who started a type of diabetes medication called SGLT2 inhibitors within the 3 months before the first study visit
• People who started taking a water tablet (diuretic) or had their diuretic dose increased within the 3 months before the first study visit
• People who are taking certain heart medications, specifically calcium channel blockers such as verapamil or diltiazem, or digoxin-type medications (digitalis)
• People who were hospitalised for a heart-related reason within the 3 months before the first study visit
• People who are known to have an allergic reaction to the study drug acoramidis or any of its ingredients
• People who have a condition — such as a history of substance abuse, alcohol dependence, or a psychiatric illness — that a doctor believes would make it difficult to follow the study requirements
• People who have a known or suspected liver condition, including problems with bile flow (cholestasis), or a history of such conditions
• People whose liver function blood test results are significantly above the normal range at the first study visit

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