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NCT07791160Recruiting

Study of Acoramidis in Patients With Transthyretin Amyloid Cardiomyopathy

A Prospective, Longitudinal, Multi-center, Observational Study of Acoramidis In Patients With Wild-type or Variant Transthyretin Amyloid Cardiomyopathy (ATTR-CM): MOSAIC-TTR Study

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

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). The main goal of the study is to understand how patients' quality of life, daily functioning, and overall well-being change during the first 12 months of treatment with acoramidis, using questionnaires completed by the patients themselves. The study will also collect information about the characteristics of patients receiving acoramidis, how the medicine is used in routine clinical practice, and its safety and tolerability. The information collected will help improve the understanding of ATTR-CM and may help improve the care of people living with this condition.

Status (registry)
Recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
25 Aug 2026
Start date
7 Sept 2026
Primary completion date
31 Dec 2028
Lead sponsor
Bayer
Diseases
Amyloidosis
NCT number
NCT07791160

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 7 Sept 2026 to the primary completion date, 31 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with disease-modifying treatment (e.g., tafamidis, TTR silencers and/or depleters)

Other

  • Any contraindications as listed in the local approved product information
  • 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.

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Many LocationsFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.