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ACO-REALAcoramidis Use in ATTR Amyloidosis with Cardiomyopathy

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Study Aim

This study observes adults with transthyretin amyloid cardiomyopathy to understand the clinical characteristics and treatment patterns associated with acoramidis use.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cardiovascular Diseases+1

+ Heart Diseases

+ Heart Failure

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2025
See protocol details

Summary

Principal SponsorBayer
Study ContactBayer Clinical Trials Contact
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 29, 2025

Actual date on which the first participant was enrolled.

Transthyretin Amyloid Cardiomyopathy, or ATTR-CM, is a condition where a protein called transthyretin misfolds and builds up in the heart muscle, causing the heart to become stiff and leading to heart failure. There are two types of ATTR-CM: one caused by a genetic mutation and another associated with aging. The condition is often diagnosed late because its symptoms can resemble other heart issues. Acoramidis is a new medication approved for treating ATTR-CM by stabilizing the transthyretin protein, preventing harmful deposits. This study, named ACO-REAL, aims to gather real-world evidence on how acoramidis works for patients in everyday medical practice. It is conducted across 20 European countries and will involve up to 2,000 adults with either form of ATTR-CM who are beginning treatment with acoramidis. In this observational study, researchers will not change how patients are treated. Instead, they will observe patients who are receiving acoramidis as part of their regular care. The study will collect detailed information about the patients, including their demographics and medical history, to understand who is receiving the medication. It will also track how the treatment affects heart function, the ability to perform daily activities, overall health, quality of life, and the use of healthcare services like hospital visits. Additionally, safety data will be gathered to monitor how often the medication is stopped or interrupted and why. This real-world data will help improve the management and treatment of ATTR-CM, offering insights that could enhance patient care.

Official TitleACO-REAL - A Non-interventional Study Providing Insights Into the Use of Acoramidis in Patients With ATTR Amyloidosis With Cardiomyopathy (ATTR-CM) in Routine Clinical Practice
Principal SponsorBayer
Study ContactBayer Clinical Trials Contact
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart FailureCardiomyopathies

Criteria

5 inclusion criteria required to participate
Signed ICF.

Decision to initiate treatment with acoramidis was made as per treating investigator's routine treatment practice before signature of ICF.

- Adults (≥18 years at the date of signing the informed consent form (ICF)).

Diagnosis of either wild-type or variant ATTR-CM.

Show More Criteria

3 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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Universitaetsklinik Heidelberg

Heidelberg, GermanyOpen Universitaetsklinik Heidelberg in Google Maps
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One Study Center