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Study of Acoramidis in Patients With Transthyretin Amyloid Cardiomyopathy

Study acronym: MOSAIC-TTR
StatusRecruiting
PhaseNot specified
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Sep 1, 2026 to Sep 7, 2026 · Eligibility criteria expanded, about 7 words · 3 more Show 6 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 1, 2026 to Sep 7, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 14 entries
    • Collaborators: details revised at 1 of 2 entries
    • Publications: details revised at 2 of 2 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Bayer
131 trials monitored
See 7 trials at risk
Amyloidosis
301 trials monitored
See 19 trials at risk
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.
Trial Details
NCT Number NCT07791160
Lead Sponsor Bayer
Collaborators: Saving Lives Matters, Heart's Foundation
Conditions Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov