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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 Switch From Tafamidis to Acoramidis

RecruitingPhase 4Ages 18 Years - 90 YearsAllBayer
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In plain words

What the trial is, and whether it could suit you

Transthyretin (TTR) is a protein made by the liver that helps transport thyroid hormone and vitamin A in the blood. In some people, this protein breaks down and forms harmful clumps called amyloid. TTR amyloid gets deposited in the heart wall and stops it from pumping blood properly, which may lead to heart failure. The breakage in TTR protein can be age-related (wild-type ATTR-CM), or genetic (variant ATTR-CM). The study drug, acoramidis, works by attaching itself to the TTR protein, making TTR more stable and less likely to break down and form amyloid (clumps). This helps to slow down the progression of the disease, improve heart function, and increase the TTR levels in the blood. Acoramidis is an approved treatment for wild-type or variant ATTR-CM in Europe and the United States. Tafamidis is another drug that stabilizes TTR and prevents it from breaking down. In this study, acoram

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Acoramidis
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Where

26 sites
Universitätsklinikum St. Pölten - Lilienfeld - Klinische Abteilung für Innere Medizin 3
Sankt Pölten, Austria
Medizinische Universität Wien- Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie
Vienna, Austria
Klinik Favoriten - 5.Medizinische Abteilung-Kardiologie
Vienna, Austria
Klinik Ottakring - 3. Medizinische Abteilung mit Kardiologie, internistischer Intensivmedizin und Ambulanz
Vienna, Austria
Medizinische Universität Graz- Klinische Abteilung für Kardiologie
Vienna, Austria
Krankenhaus St. Josef Braunau | Innere Medizin I
Braunau am Inn, Austria
VIVIT - Landeskrankenhaus Feldkirch - Innere Medizin I, Kardiologie, Angiologie, Endokrinologie, Diabetologie, Intensivmedizin
Feldkirch, Austria
Hôpital Erasme/Erasmus Ziekenhuis
Brussels, Belgium

…and 18 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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