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New heart drug acoramidis tested in Real-World setting

NCT ID NCT07235462

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This observational study follows up to 2,000 adults with ATTR-CM, a serious heart condition, who are starting treatment with acoramidis as part of their normal care. Researchers will track patient characteristics, how the drug is used, and its effects on heart function and quality of life. The goal is to gather real-world evidence on acoramidis to improve management of this progressive disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Acoramidis (brand name BEYONTTRA)
What this could lead to
If successful, this study will show how well acoramidis works in everyday medical practice, helping doctors better manage ATTR-CM and improve patient care.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It only includes patients already prescribed acoramidis, which may limit generalizability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with an established diagnosis of either wild-type or variant Transthyretin Amyloid Cardiomyopathy (ATTR-CM) who are eligible for treatment with acoramidis based on the clinical decision of the investigator, made independently of the study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * \- Adults (≥18 years at the date of signing the informed consent form (ICF)). * Diagnosis of either wild-type or variant ATTR-CM. * Signed ICF. * Decision to initiate treatment with acoramidis was made as per treating investigator's routine treatment practice before signature of ICF. * Treatment start with acoramidis within 90 days after signing the ICF, with the possibility of starting acoramidis on the same day as signing the ICF. Exclusion Criteria: * Participation in an investigational trial with interventions outside of routine clinical practice, except for participation in potential sub-studies related to this observational study. Please note: In addition to this observational study, separate sub-studies may be conducted to collect additional data. Participation in these sub-studies is voluntary and will be governed by separate protocols and informed consent processes. The main observational study does not include interventional procedures beyond routine clinical practice. * Contra-indications according to the local SmPC of acoramidis. * Patients who are unable to provide consent, including those whose consent would need to be given by a legal representative.

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Conditions

The condition(s) this trial relates to.

cardiomyopathy familial amyloid neuropathy heart failure wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transthyretin amyloid cardiomyopathy (attr-CM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Universitaetsklinik Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.