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A study to learn more about the change in the blood levels of transthyretin when participants with transthyretin amyloidosis with cardiomyopathy switched from tafamidis to acoramidis
EU CTIS ID: 2025-521831-35-00
What this study is testing
To evaluate the change of serum TTR level associated with acoramidis treatment in patients with ATTR-CM switching from tafamidis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be 18 to 90 years of age inclusive, at the time of signing the informed consent.
- Diagnosis of ATTR-CM; disease defining examination, i.e., SPECT or SPECT/CT or biopsy, within 24 months prior to V1
- Participants must currently be treated with tafamidis and have used tafamidis for at least the previous 3 months prior to V1 and have adhered to tafamidis therapy
- NYHA class ≤ II at V1
- eGFR ≥ 30 mL/min/1.73m2 at V1
- NT-proBNP > 300 and ≤ 7000 pg/mL at V1
You likely can't join if
- Prior liver or heart transplantation or planned within the next 12 months
- Initiation of treatment with a diuretic or increase in diuretic dose within 3 months before V1
- Treatment with calcium channel blockers (e.g., verapamil, diltiazem) or digitalis required
- Recent CV hospitalization within 3 months before V1
- Known hypersensitivity to acoramidis or to any of the excipients
- A condition that, as judged by the investigator, would preclude compliance with the study protocol, such as a history of substance abuse, alcoholism, or a psychiatric condition
See the full eligibility criteria
- Participant must be 18 to 90 years of age inclusive, at the time of signing the informed consent.
- Diagnosis of ATTR-CM; disease defining examination, i.e., SPECT or SPECT/CT or biopsy, within 24 months prior to V1
- Participants must currently be treated with tafamidis and have used tafamidis for at least the previous 3 months prior to V1 and have adhered to tafamidis therapy
- NYHA class ≤ II at V1
- eGFR ≥ 30 mL/min/1.73m2 at V1
- NT-proBNP > 300 and ≤ 7000 pg/mL at V1
- Prior liver or heart transplantation or planned within the next 12 months
- Initiation of treatment with a diuretic or increase in diuretic dose within 3 months before V1
- Treatment with calcium channel blockers (e.g., verapamil, diltiazem) or digitalis required
- Recent CV hospitalization within 3 months before V1
- Known hypersensitivity to acoramidis or to any of the excipients
- A condition that, as judged by the investigator, would preclude compliance with the study protocol, such as a history of substance abuse, alcoholism, or a psychiatric condition
- Known or suspected liver disorder and bile secretion/flow (cholestasis, also history of it)
- Abnormal liver function tests at V1, defined as ALT (GPT) or AST (GOT) ≥ 3 x ULN or total bilirubin ≥ 3 x ULN at V1
- Current or planned use of ventricular assist device
- Active cancer or other disease that decreases the life expectancy to less than one year
- Heart failure due to ischemic heart disease
- Myocardial infarction, CV surgery, or unstable angina within the last 90 days prior to V1
- Confirmed diagnosis of light-chain amyloidosis
- Dialysis or severe renal impairment as reflected by UACR > 300 mg/g at V1
- Major surgery 90 days prior to V1
- Recent initiation of SGLT2i within 3 months before V1
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.