Acoramidis for transthyretin amyloid cardiomyopathy in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Many Locations
  Multiple Locations, Austria Recruiting
• Many Locations
  Multiple Locations, Belgium Recruiting
• Many Locations
  Multiple Locations, Croatia Recruiting
• Many Locations
  Multiple Locations, Denmark Recruiting
• Many Locations
  Multiple Locations, Estonia Recruiting
• Many Locations
  Multiple Locations, Finland Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 0018888422

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acoramidis in adults with transthyretin amyloid cardiomyopathy in France

  This is an observational study to see how acoramidis is used in everyday care for adults with ATTR‑CM in France and how it affects their quality of life and daily function.

  Recruiting Bayer · Many Locations · NCT07791160

• Coramitug (NNC6019-0001) for heart failure from transthyretin amyloid cardiomyopathy

  This study tests whether coramitug (NNC6019-0001) can lower the risk of heart-related death and illness in adults with transthyretin amyloid cardiomyopathy (ATTR-CM) while they continue their usual heart medicines.

  Recruiting at 237 sites Phase 3 Novo Nordisk A/S · Phoenix, Arizona and 298 other locations · NCT07207811

• Registry for studying Transthyretin Amyloid Cardiomyopathy in Thailand

  This study is collecting information from people with Transthyretin Amyloid Cardiomyopathy in Thailand to better understand the disease and improve early detection and treatment options.

  Recruiting Mahidol University · Bangkok and 7 other locations · NCT06338696

• US benchmarking of heart and liver stiffness using shear wave ultrasound

  This project will test whether a new ultrasound device can measure heart and liver stiffness using shear wave velocity in people aged 60 or older with preserved or mildly reduced ejection fraction and left ventricular hypertrophy, with or without transthyretin amyloid cardiomyopathy, and in control subjects.

  Recruiting at 3 sites eMyosound SAS · Boston, Massachusetts and 2 other locations · NCT07215715

• Acoramidis for ATTR-CM: Cardiac Imaging Study

  This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.

  Recruiting Phase 4 Eidos Therapeutics, a BridgeBio company · St Louis, Missouri · NCT07695701

• Investigating early signs of heart disease in specific genetic carriers

  This study is trying to find early signs of heart disease in people with a specific genetic mutation linked to a heart condition called amyloidosis to help catch the disease sooner.

  Recruiting at 3 sites University of Texas Southwestern Medical Center · New York, New York and 2 other locations · NCT05489549

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.