ClinicalTrials.gov record NCT07791160

Study of Acoramidis in Patients With Transthyretin Amyloid Cardiomyopathy

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age18 years old and older

SexAll

LocationFrance

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study follows people with wild-type or variant transthyretin amyloid cardiomyopathy (ATTR-CM) who begin treatment with acoramidis as part of usual care. No experimental treatments or additional medical procedures are required. The study will gather hospital data and registry data (HEAR) and ask patients to complete quality-of-life questionnaires during the first 12 months of treatment.

What it is studying. How acoramidis is used in routine clinical practice; how patients' quality of life, daily functioning, and well‑being change during the first 12 months of treatment; and the drug's safety and tolerability in real-world use.

What the researchers hope to learn. To describe characteristics of patients treated with acoramidis, how the medicine is used in routine practice, changes in patient-reported quality of life and function over 12 months, treatment patterns, and the safety and tolerability of acoramidis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Acoramidis

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you take part, you will receive acoramidis as part of your usual medical care; the study does not require experimental treatments or extra medical procedures beyond routine care. The study will collect medical information from participating hospitals and from the Healthcare European Amyloidosis Registry (HEAR) and will ask participants to complete quality-of-life and heart-symptom questionnaires (Amylo-AFFECT-QOL, KCCQ-23, EQ-5D-3L including EQ VAS) at baseline and at 3, 6, 9 and 12 months after starting treatment. Researchers will also record patient and clinical characteristics, how acoramidis is used (treatment duration, interruptions, discontinuation), other medications and procedures, and any adverse events during treatment and up to 6 days after the last dose if treatment is stopped early.

How the study is structured. This is a prospective, observational study. Participants receive acoramidis as part of their usual care (the registry notes the usual dose as 712 mg orally twice daily) and are not given any experimental treatments by the study. The study collects data from participating hospitals and the Healthcare Amyloidosis European Registry (HEAR), and asks patients to complete questionnaires (Amylo-AFFECT-QOL, KCCQ-23, EQ-5D-3L including EQ VAS) at about 3, 6, 9, and 12 months after starting acoramidis. The study also records demographics, clinical characteristics, treatment patterns (duration, interruptions, discontinuation), concomitant treatments, and adverse events.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Does it apply to my diagnosis?
This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Sep 7, 2026
Primary completion: Dec 31, 2028 (estimated)
Study completion: Dec 31, 2028 (estimated)
Target enrollment: 500 participants (estimated)
Last updated on registry: Sep 15, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Bayer
Collaborators: Saving Lives Matters
Heart's Foundation

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Bayer Clinical Trials Contact 📞 4930300139003 ✉ clinical-trials-contact@bayer.com

Participating sites (1)

Many locationsRecruiting
Many Locations · France

Terms used on this page · explanations by MedicalUpdates.ai

Registry: An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
enrolment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
contraindications: A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Prior treatment: Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
investigational: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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