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NCT Number: NCT07791160

Study of Acoramidis in Patients With Transthyretin Amyloid Cardiomyopathy

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.

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Key information

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acoramidis

Drug

356 mg film-coated tablets. The recommended dose is 712 mg (two tables, 356 mg) orally twice daily, corresponding to a total daily dose of 1424 mg.

Other names: BAY3684938, BEYONTTRA

Primary outcomes

  1. Patient Reported Outcome Measure: Amylo-AFFECT-QOL score

    Time frame: At 3, 6, 9, and 12 months after initiation of acoramidis

    Change from baseline in Amylo-AFFECT-QOL total score

  2. Patient Reported Outcome Measure: KCCQ-23 score

    Time frame: At 3, 6, 9, and 12 months after initiation of acoramidis

    Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) total score

  3. Patient Reported Outcome Measure: EQ-5D-3L index score

    Time frame: At 3, 6, 9, and 12 months after initiation of acoramidis

    3L index score of EQ-5D Health-Related Quality of Life Questionnaire

  4. Patient Reported Outcome Measure: EQ VAS score

    Time frame: At 3, 6, 9, and 12 months after initiation of acoramidis

    Visual Analog scale score of EQ-5D Health-Related Quality of Life Questionnaire

Secondary outcomes

  1. Demographic characteristics: Age

    Time frame: Before treatment with acoramidis

    Age of patients initiating treatment with acoramidis

  2. Demographic characteristics: Sex

    Time frame: Before treatment with acoramidis

    Sex of patients initiating treatment with acoramidis

  3. Demographic characteristics: Body Mass Index

    Time frame: Before treatment with acoramidis

    Body Mass Index of patients initiating treatment with acoramidis

  4. Clinical characteristics: Time between diagnosis and treatment initiation

    Time frame: Before treatment with acoramidis

    Time between ATTR-CM diagnosis and treatment initiation

  5. Clinical characteristics: ATTR-CM diagnosis

    Time frame: Before treatment with acoramidis

    ATTR-CM diagnosis (genetic status including mutation type [if applicable], phenotype)

  6. Clinical characteristics: ATTR-CM manifestations

    Time frame: Before treatment with acoramidis

    ATTR-CM manifestations prior to treatment initiation

  7. Clinical characteristics: Comorbidities

    Time frame: Up to 12 months before initiation of acoramidis, and during treatment with acoramidis

    ATTR-CM-relevant comorbidities that were either ongoing at treatment initiation, or were previously managed or resolved in the 12 months prior to initiating acoramidis, as well as those that began after initiating acoramidis

  8. Clinical characteristics: Prior medication and procedures

    Time frame: Up to 12 months before initiation of acoramidis

    Prior medication taken and procedures performed up to 12 months before initiation of acoramidis

  9. Treatment patterns: Treatment duration

    Time frame: During treatment with acoramidis

    Duration of treatment with acoramidis

  10. Treatment patterns: Treatment interruptions

    Time frame: During treatment with acoramidis

    Proportion of patients with temporary treatment interruptions and reason for interruption

  11. Treatment patterns: Treatment discontinuation

    Time frame: During treatment with acoramidis

    Proportion of patients with permanent treatment discontinuation and reason for discontinuation

  12. Treatment patterns: Time to treatment discontinuation

    Time frame: During treatment with acoramidis

    Time to acoramidis treatment discontinuation

  13. Treatment patterns: Concomitant medications and procedures

    Time frame: During treatment with acoramidis

    Concomitant medications taken and procedures performed during treatment with acoramidis

  14. Safety and tolerability: Adverse events

    Time frame: During treatment with acoramidis and up to 6 days after the last intake of acoramidis in case of premature permanent treatment discontinuation

    Adverse events (AEs) occurring during treatment with acoramidis and AEs occurring up to 6 days after the last intake of acoramidis if premature permanent treatment discontinuation

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

4930300139003

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Heart's Foundation
  • Saving Lives Matters

Registry information

Official study title

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

Acronym: MOSAIC-TTR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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