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ACO-REAL / Study in patients with ATTR-CM

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 - ACO-REAL in patients with ATTR-CM

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58470
Enrollment
40
Registered
2026-01-19
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthyretin Amyloid Cardiomyopathy Transthyretin Amyloid Cardiomyopathy (ATTR heart disease)

Interventions

Acoramidis&nbsp
(Beyonttra)

Sponsors

Bayer
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 initiation 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

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.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.

Design outcomes

Primary

MeasureTime frame
To assess characteristics and treatment patterns of ATTR-CM patients initiating acoramidis. 

Secondary

MeasureTime frame
To describe the reported safety profile of acoramidis.

Countries

Austria, Belgium, Croatia, Denmark, Estonia, Finland, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, United Kingdom

Contacts

Public ContactE.J. Koning

Bayer

els.koning@bayer.com+31 6 43842318

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026