Switching from tafamidis to acoramidis to see how transthyretin blood levels change

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study enrolls adults with confirmed ATTR-CM who have been taking tafamidis for at least three months and are NYHA class I–II. Participants will stop tafamidis and start acoramidis, with scheduled blood draws to measure transthyretin (TTR) levels and routine cardiac and laboratory assessments including NT-proBNP and kidney function. The study aims to document the change in circulating TTR after the switch and to characterize safety and tolerability in this population. Study sites are located in Austria and the sponsor is Bayer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants 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., Single Photon Emission Computed Tomography (SPECT) or SPECT/Computed Tomography (CT) or biopsy, within 24 months prior to Visit 1 (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.
* New York Heart Association (NYHA) class ≤ II at V1.
* Estimate glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2 at V1.
* N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) \> 300 and ≤ 7000 pg/mL at V1.

Exclusion Criteria:

* Prior liver or heart transplantation or planned within the next 12 months.
* 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, cardiovascular (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 Urinary Albumin Creatinine Ratio (UACR) \> 300 mg/g at V1.
* Major surgery within 90 days prior to V1.
* Recent initiation of Sodium-Glucose-Cotransporter-2 inhibitors (SGLT2i) within 3 months before V1.
* 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.
* 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.

Where it's running

• Medizinische Universität Wien- Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie
  Vienna, State of Vienna, Austria Recruiting
• Klinik Favoriten - 5.Medizinische Abteilung-Kardiologie
  Vienna, State of Vienna, Austria Recruiting
• Medizinische Universität Graz- Klinische Abteilung für Kardiologie
  Vienna, Styria, Austria Recruiting
• Krankenhaus St. Josef Braunau | Innere Medizin I
  Braunau am Inn, Upper Austria, Austria Recruiting
• Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 1
  Bergamo, Lombardy, Italy Recruiting
• Centro Cardiologico Monzino S.p.A. - Cardiologia Peri-Operatoria e Imaging Cardiovascolare
  Milan, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 18888422937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.