Acoramidis for transthyretin amyloid cardiomyopathy in routine care
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
See how acoramidis works for adults with transthyretin amyloid cardiomyopathy (wild-type or variant) when given as part of regular clinical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT07235462 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults diagnosed with wild-type or variant ATTR-CM who are starting acoramidis as part of routine treatment to collect real-world data on use, safety, and outcomes. Patients must start acoramidis within 90 days of signing consent, and the study does not add interventional procedures beyond usual care. Data collection may include clinical visits, imaging, and routine lab results and could include optional sub-studies with separate consent. The goal is to document how the medication is used and performs in everyday clinical practice outside of a controlled trial setting.
Who should consider this trial
Good fit: Adults (18+) diagnosed with wild-type or variant ATTR-CM who have decided with their doctor to start acoramidis and can provide informed consent are ideal candidates.
Not a fit: Patients who are not starting acoramidis, who cannot consent, or who are currently enrolled in other interventional clinical trials may not benefit from participation.
Why it matters
Potential benefit: If successful, this study could clarify real-world safety and effectiveness of acoramidis and help doctors optimize its use for people with ATTR-CM.
How similar studies have performed: Acoramidis showed efficacy and safety in the pivotal ATTRibute-CM randomized trial leading to approval, and this study aims to confirm those findings in routine care.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Heidelberg
- Universitaetsklinik Heidelberg — Heidelberg, Germany (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.