Transthyretin Amyloid Cardiomyopathy (ATTR-CM)ACO-REALNCT07235462
A Study to Learn About the Use of Acoramidis in Patients With a Heart Condition Called Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in a Real-world Setting
An observational study of Transthyretin Amyloid Cardiomyopathy (ATTR-CM), run by Bayer at 17 sites in 17 countries.
Trial summary
Transthyretin Amyloid Cardiomyopathy (ATTR-CM) is a serious and life-threatening condition where a protein called transthyretin (TTR) misfolds and builds up as amyloid fibrils in the heart muscle. This buildup causes the heart to become stiff, leading to restrictive cardiomyopathy and progressive heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
- What is being tested?
- Acoramidis (356 mg film-coated tablets)
- Type of treatment
- Pill or oral medicine
- How many people
- 2,000 participants
- Where
- 17 sitesin 17 countries
- Study dates
- 29 Oct 2025to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- - 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 17 countries
Switzerland1 site, 1 recruiting
- Recruiting
Many Locations
Multiple Locations
United Kingdom1 site, 1 recruiting
- Recruiting
Many Locations
Multiple Locations
About this study
Official title: ACO-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
Transthyretin Amyloid Cardiomyopathy (ATTR-CM) is a serious and life-threatening condition where a protein called transthyretin (TTR) misfolds and builds up as amyloid fibrils in the heart muscle. This buildup causes the heart to become stiff, leading to restrictive cardiomyopathy and progressive heart failure. There are two forms of ATTR-CM: a hereditary or 'variant' form (vATTR-CM) caused by a gene mutation, and a 'wild-type' form (wtATTR-CM) which is associated with aging. Because its symptoms can be similar to other heart conditions, ATTR-CM is often diagnosed late. However, recent advances in medical imaging are helping doctors to identify the disease earlier. Acoramidis is a new medication designed to treat ATTR-CM. It works by stabilizing the TTR protein, preventing it from misfolding and forming the harmful amyloid deposits. Acoramidis has been shown to be effective and safe in a major clinical trial (the ATTRibute-CM study), which led to its approval for use in both the United States and Europe. While clinical trials provide valuable information, data on how a new medicine performs in everyday clinical practice is also very important. This type of information is called real-world evidence. Currently, there is limited real-world information about the use of acoramidis. This study, called ACO-REAL, is an observational study, which means researchers will observe patients who are receiving acoramidis as part of their normal clinical care, without introducing any experimental interventions. The study will take place in approximately 20 European countries and aims to enroll up to 2,000 adults who have been diagnosed with either wild-type or variant ATTR-CM and are starting treatment with acoramidis. This includes patients who have not been treated for ATTR-CM before, as well as those who have been treated with other therapies. The main goals of the study are to understand the characteristics of patients being treated with acoramidis and to document how the treatment is used in routine medical practice. The study will also collect information on the safety of acoramidis. Furthermore, researchers will assess how the treatment affects patients' heart function, their functional capacity (such as their ability to walk), their overall health status, and their quality of life. The study will also track how often patients need to use healthcare resources like hospitals or emergency rooms. This information will help to improve the understanding and management of ATTR-CM in a real-world setting, ultimately aiming to optimize care for patients with this progressive disease.
- Being tested
- Acoramidis (356 mg film-coated tablets)
- Keywords
- Transthyretin Amyloidosis, Cardiomyopathy, Heart Failure, Wild-type Amyloidosis
- Medical subject headings
- Amyloidosis, Hereditary, Transthyretin-Related, Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoramidis (356 mg film-coated tablets)Drug
Also called BEYONTTRA
Follow clinical practice/administration.
| Study group | Role | What they receive |
|---|---|---|
| Acoramidis Arm | Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) initiating treatment with acoramidis in routine clinical practice. Receives: Drug: Acoramidis (356 mg film-coated tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient demographic characteristics: age
Demographic characteristics at the first documented regular visit in the study, referred to as the initial study visit.
Measured: Baseline (Initial study visit)
Patient demographic characteristics: sex
Demographic characteristics at the first documented regular visit in the study, referred to as the initial study visit.
Measured: Baseline (Initial study visit)
Patient demographic characteristics: race
Demographic characteristics at the first documented regular visit in the study, referred to as the initial study visit.
Measured: Baseline (Initial study visit)
Patient demographic characteristics: height
Demographic characteristics at the first documented regular visit in the study, referred to as the initial study visit.
Measured: Baseline (Initial study visit)
Patient demographic characteristics: weight
Demographic characteristics at the first documented regular visit in the study, referred to as the initial study visit.
Measured: Baseline (Initial study visit)
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Type
ATTR-CM type: mixed phenotype (yes/no)
Measured: Baseline up to 15 months
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Genetic status
ATTR-CM type: genetic status (mutation / wild type; if mutation: genotype and zygosity)
Measured: Baseline up to 15 months
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Diagnosis
ATTR-CM diagnosis (year of diagnosis)
Measured: Baseline up to 15 months
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Setting of Diagnosis
ATTR-CM setting of diagnosis: (endomyocardial biopsy
/ non-invasive / both, NYHA classification at diagnosis)
Measured: Baseline up to 15 months
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Manifestations
ATTR-CM manifestations (type)
Measured: Baseline up to 15 months
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) -relevant comorbidities
ATTR-CM-relevant comorbidities (type)
Measured: Baseline up to 15 months
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) -relevant procedures
Prior and concomitant ATTR-CM-relevant procedures (type)
Measured: Baseline up to 15 months
Treatment Patterns with Acoramidis: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) -related medications
Previously administered ATTR-CM-related medications within the past 12 months before initial visit (name)
Measured: Baseline (assessment within the past 12 months prior to initiation)
Treatment Patterns with Acoramidis: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) concomitant medications
Concomitant medications administered alongside acoramidis (name)
Measured: Baseline up to 15 months
Treatment Patterns with Acoramidis: Initiation
Acoramidis initiation (date)
Measured: Baseline up to 15 months
Treatment Patterns with Acoramidis: Initiation after a different therapy
Acoramidis initiation (if patient is switching from a different therapy: reason for switch)
Measured: Baseline up to 15 months
Treatment Patterns with Acoramidis: discontinuation
Acoramidis discontinuation (reason)
Measured: Baseline up to 15 months
Treatment Patterns with Acoramidis: interruption
Acoramidis interruption (reason)
Measured: Baseline up to 15 months
Treatment Patterns with Acoramidis: prescription / refills
Acoramidis prescriptions/refills since the last visit or telephone contact (duration of time from initiation to discontinuation of therapy)
Measured: Baseline up to 15 months
Secondary outcomes (2)
Incidence of Adverse Events
Adverse events (AEs) documentation
Measured: From acoramidis initiation up to end of observation (approximately 12-15 months).
Incidence of Serious Adverse Events
Serious Adverse events (SAEs) documentation
Measured: From acoramidis initiation up to end of observation (approximately 12-15 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start29 Oct 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235462
- Sponsor's protocol ID
- 23023
- Acronym
- ACO-REAL
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Fontana M, Cappelli F, Gillmore JD, Obici L, Siepen FAD, Debonnaire P, Gonzalez-Lopez E, Schulze M, Vogtlander K, Ciaccia A, Merz M, Garcia-Pavia P. Rationale and Design of ACO-REAL: A Real-World Non-Interventional Study of Acoramidis in Routine Clinical Practice. Cardiol Ther. 2026 Jul 31. doi: 10.1007/s40119-026-00461-9. Online ahead of print.
PubMed 42533192
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACO-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
- ClinicalTrials.gov ID
- NCT07235462
- Acronym / sponsor ID
- ACO-REAL / 23023
- Keywords
- Transthyretin Amyloidosis, Cardiomyopathy, Heart Failure, Wild-type Amyloidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transthyretin Amyloid Cardiomyopathy (ATTR-CM) is a serious and life-threatening condition where a protein called transthyretin (TTR) misfolds and builds up as amyloid fibrils in the heart muscle. This buildup causes the heart to become stiff, leading to restrictive cardiomyopathy and progressive heart failure. There are two forms of ATTR-CM: a hereditary or 'variant' form (vATTR-CM) caused by a gene mutation, and a 'wild-type' form (wtATTR-CM) which is associated with aging. Because its symptoms can be similar to other heart conditions, ATTR-CM is often diagnosed late. However, recent advances in medical imaging are helping doctors to identify the disease earlier. Acoramidis is a new medication designed to treat ATTR-CM. It works by stabilizing the TTR protein, preventing it from misfolding and forming the harmful amyloid deposits. Acoramidis has been shown to be effective and safe in a major clinical trial (the ATTRibute-CM study), which led to its approval for use in both the United States and Europe. While clinical trials provide valuable information, data on how a new medicine performs in everyday clinical practice is also very important. This type of information is called real-world evidence. Currently, there is limited real-world information about the use of acoramidis. This study, called ACO-REAL, is an observational study, which means researchers will observe patients who are receiving acoramidis as part of their normal clinical care, without introducing any experimental interventions. The study will take place in approximately 20 European countries and aims to enroll up to 2,000 adults who have been diagnosed with either wild-type or variant ATTR-CM and are starting treatment with acoramidis. This includes patients who have not been treated for ATTR-CM before, as well as those who have been treated with other therapies. The main goals of the study are to understand the characteristics of patients being treated with acoramidis and to document how the treatment is used in routine medical practice. The study will also collect information on the safety of acoramidis. Furthermore, researchers will assess how the treatment affects patients' heart function, their functional capacity (such as their ability to walk), their overall health status, and their quality of life. The study will also track how often patients need to use healthcare resources like hospitals or emergency rooms. This information will help to improve the understanding and management of ATTR-CM in a real-world setting, ultimately aiming to optimize care for patients with this progressive disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acoramidis Arm | – | Drug: Acoramidis (356 mg film-coated tablets)Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) initiating treatment with acoramidis in routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- - 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoramidis (356 mg film-coated tablets)Also: BEYONTTRAFollow clinical practice/administration. | Drug | Acoramidis Arm |
Primary outcome
Patient demographic characteristics: age
Time frame: Baseline (Initial study visit)
Demographic characteristics at the first documented regular visit in the study, referred to as the initial study visit.
Patient demographic characteristics: sex
Time frame: Baseline (Initial study visit)
Demographic characteristics at the first documented regular visit in the study, referred to as the initial study visit.
Patient demographic characteristics: race
Time frame: Baseline (Initial study visit)
Demographic characteristics at the first documented regular visit in the study, referred to as the initial study visit.
Patient demographic characteristics: height
Time frame: Baseline (Initial study visit)
Demographic characteristics at the first documented regular visit in the study, referred to as the initial study visit.
Patient demographic characteristics: weight
Time frame: Baseline (Initial study visit)
Demographic characteristics at the first documented regular visit in the study, referred to as the initial study visit.
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Type
Time frame: Baseline up to 15 months
ATTR-CM type: mixed phenotype (yes/no)
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Genetic status
Time frame: Baseline up to 15 months
ATTR-CM type: genetic status (mutation / wild type; if mutation: genotype and zygosity)
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Diagnosis
Time frame: Baseline up to 15 months
ATTR-CM diagnosis (year of diagnosis)
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Setting of Diagnosis
Time frame: Baseline up to 15 months
ATTR-CM setting of diagnosis: (endomyocardial biopsy / non-invasive / both, NYHA classification at diagnosis)
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Manifestations
Time frame: Baseline up to 15 months
ATTR-CM manifestations (type)
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) -relevant comorbidities
Time frame: Baseline up to 15 months
ATTR-CM-relevant comorbidities (type)
Clinical Characteristics: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) -relevant procedures
Time frame: Baseline up to 15 months
Prior and concomitant ATTR-CM-relevant procedures (type)
Treatment Patterns with Acoramidis: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) -related medications
Time frame: Baseline (assessment within the past 12 months prior to initiation)
Previously administered ATTR-CM-related medications within the past 12 months before initial visit (name)
Treatment Patterns with Acoramidis: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) concomitant medications
Time frame: Baseline up to 15 months
Concomitant medications administered alongside acoramidis (name)
Treatment Patterns with Acoramidis: Initiation
Time frame: Baseline up to 15 months
Acoramidis initiation (date)
Treatment Patterns with Acoramidis: Initiation after a different therapy
Time frame: Baseline up to 15 months
Acoramidis initiation (if patient is switching from a different therapy: reason for switch)
Treatment Patterns with Acoramidis: discontinuation
Time frame: Baseline up to 15 months
Acoramidis discontinuation (reason)
Treatment Patterns with Acoramidis: interruption
Time frame: Baseline up to 15 months
Acoramidis interruption (reason)
Treatment Patterns with Acoramidis: prescription / refills
Time frame: Baseline up to 15 months
Acoramidis prescriptions/refills since the last visit or telephone contact (duration of time from initiation to discontinuation of therapy)
2 secondary outcomes
Incidence of Adverse Events
Time frame: From acoramidis initiation up to end of observation (approximately 12-15 months).
Incidence of Serious Adverse Events
Time frame: From acoramidis initiation up to end of observation (approximately 12-15 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 42533192Fontana M, Cappelli F, Gillmore JD, Obici L, Siepen FAD, Debonnaire P, Gonzalez-Lopez E, Schulze M, Vogtlander K, Ciaccia A, Merz M, Garcia-Pavia P. Rationale and Design of ACO-REAL: A Real-World Non-Interventional Study of Acoramidis in Routine Clinical Practice. Cardiol Ther. 2026 Jul 31. doi: 10.1007/s40119-026-00461-9. Online ahead of print.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transthyretin Amyloid Cardiomyopathy (ATTR-CM), run by Bayer at 17 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Austria, Belgium, Croatia, Denmark, Estonia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact (0018888422 ext. 937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient demographic characteristics: age (time frame: Baseline (Initial study visit)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07235462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.