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Study of Acoramidis in Patients With Transthyretin Amyloid Cardiomyopathy

Recruitingn/aAges 18 Years - anyAllBayer
NCT07791160 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 progressive heart disease caused by the buildup of an abnormal protein, called transthyretin (TTR), in the heart. This buildup can make it harder for the heart to pump blood and may lead to worsening symptoms over time. Acoramidis is a medicine approved for the treatment of adults with wild-type or hereditary (variant) ATTR-CM. While its benefits have been demonstrated in clinical trials, more information is needed about how it is used and how patients do in everyday medical practice. The MOSAIC-TTR study is an observational study in France. Participants will receive acoramidis as part of their usual medical care. No experimental treatments or additional medical procedures will be required. The study will collect information directly from participating hospitals and from the Healthcare European Amyloidosis Registry (HEAR; NCT05101304).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Greater than or equal to 18 years of age * Established diagnosis of ATTR-CM with either wild-type TTR or a variant TTR genotype * Initiating treatment with acoramidis with the decision to treat having been made by the treating physician prior to study enrolment in accordance with the current French Summary of Product Characteristics (SmPC) Exclusion Criteria: * Any contraindications as listed in the local approved product information * Prior treatment with disease-modifying treatment (e.g., tafamidis, TTR silencers and/or depleters) * Participation in an investigational trial evaluating new Investigational Medicinal Products or new Investigational Medical Device outside of routine clinical practice * Under legal protection (guardianship, curatorship, or other legal protection measures) or deprived of liberty by administrative or judicial decision at the time of inclusion.
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What it tests

  • Acoramidis
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Where

1 site
Many locations
Many Locations, France
🤝 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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