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A Study to Learn About the Use of Acoramidis in Patients With a Heart Condition Called Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in a Real-world Setting

Recruitingn/aAges 18 Years - anyAllBayer
NCT07235462 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Transthyretin Amyloid Cardiomyopathy (ATTR-CM) is a serious and life-threatening condition where a protein called transthyretin (TTR) misfolds and builds up as amyloid fibrils in the heart muscle. This buildup causes the heart to become stiff, leading to restrictive cardiomyopathy and progressive heart failure. There are two forms of ATTR-CM: a hereditary or 'variant' form (vATTR-CM) caused by a gene mutation, and a 'wild-type' form (wtATTR-CM) which is associated with aging. Because its symptoms can be similar to other heart conditions, ATTR-CM is often diagnosed late. However, recent advances in medical imaging are helping doctors to identify the disease earlier. Acoramidis is a new medication designed to treat ATTR-CM. It works by stabilizing the TTR protein, preventing it from misfolding and forming the harmful amyloid deposits. Acoramidis has been shown to be effective and safe in a

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📋 Eligibility rules (as published)
Inclusion Criteria: * \- Adults (≥18 years at the date of signing the informed consent form (ICF)). * Diagnosis of either wild-type or variant ATTR-CM. * Signed ICF. * Decision to initiate treatment with acoramidis was made as per treating investigator's routine treatment practice before signature of ICF. * Treatment start with acoramidis within 90 days after signing the ICF, with the possibility of starting acoramidis on the same day as signing the ICF. Exclusion Criteria: * Participation in an investigational trial with interventions outside of routine clinical practice, except for participation in potential sub-studies related to this observational study. Please note: In addition to this observational study, separate sub-studies may be conducted to collect additional data. Participation in these sub-studies is voluntary and will be governed by separate protocols and informed consent processes. The main observational study does not include interventional procedures beyond routine clinical practice. * Contra-indications according to the local SmPC of acoramidis. * Patients who are unable to provide consent, including those whose consent would need to be given by a legal representative.
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What it tests

  • Acoramidis (356 mg film-coated tablets)
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Where

17 sites
Many Locations
Multiple Locations, Austria
Many Locations
Multiple Locations, Belgium
Many Locations
Multiple Locations, Croatia
Many Locations
Multiple Locations, Denmark
Many Locations
Multiple Locations, Estonia
Many Locations
Multiple Locations, Finland
Many Locations
Multiple Locations, Germany
Many Locations
Multiple Locations, Italy

…and 9 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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