Acoramidis in adults with transthyretin amyloid cardiomyopathy in France

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

The MOSAIC-TTR study is an observational, non-interventional effort conducted in France to collect real-world data on patients with transthyretin amyloid cardiomyopathy who are initiating acoramidis as part of routine care. Data will be gathered from participating hospitals and the HEAR registry to understand patient experiences, quality of life, and daily functioning. No experimental procedures are required beyond standard treatment decisions, and no additional interventions are mandated. The study aims to supplement clinical trial data with real-world evidence about how the therapy performs in typical clinical settings. Eligible adults start acoramidis based on physician decision, and information is collected to reflect everyday practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Many locations
  Many Locations, France Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 4930300139003

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acoramidis for transthyretin amyloid cardiomyopathy in routine care

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• Coramitug (NNC6019-0001) for heart failure from transthyretin amyloid cardiomyopathy

  This study tests whether coramitug (NNC6019-0001) can lower the risk of heart-related death and illness in adults with transthyretin amyloid cardiomyopathy (ATTR-CM) while they continue their usual heart medicines.

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• Registry for studying Transthyretin Amyloid Cardiomyopathy in Thailand

  This study is collecting information from people with Transthyretin Amyloid Cardiomyopathy in Thailand to better understand the disease and improve early detection and treatment options.

  Recruiting Mahidol University · Bangkok and 7 other locations · NCT06338696

• US benchmarking of heart and liver stiffness using shear wave ultrasound

  This project will test whether a new ultrasound device can measure heart and liver stiffness using shear wave velocity in people aged 60 or older with preserved or mildly reduced ejection fraction and left ventricular hypertrophy, with or without transthyretin amyloid cardiomyopathy, and in control subjects.

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• Acoramidis for ATTR-CM: Cardiac Imaging Study

  This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.

  Recruiting Phase 4 Eidos Therapeutics, a BridgeBio company · St Louis, Missouri · NCT07695701

• Investigating early signs of heart disease in specific genetic carriers

  This study is trying to find early signs of heart disease in people with a specific genetic mutation linked to a heart condition called amyloidosis to help catch the disease sooner.

  Recruiting at 3 sites University of Texas Southwestern Medical Center · New York, New York and 2 other locations · NCT05489549

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.