RecruitingOBSERVATIONAL

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

This study, called ACO-REAL, is looking at how a new medication called Acoramidis works for people with a serious heart condition called Transthyretin Amyloid Cardiomyopathy (ATTR-CM). ATTR-CM happens when a protein builds up in the heart, making it stiff. Acoramidis helps stop this protein buildup. While we know the medicine works from previous trials, this study will gather 'real-world' information. It will observe up to 2,000 adults across Europe who are starting Acoramidis as part of their normal care. Researchers want to understand who is taking the medicine, how it's being used, and if it helps with heart function, daily activities, and overall well-being. This will help doctors give the best care to people with ATTR-CM.

At a glance

Status

Recruiting

Sponsor

Bayer

Enrolment target

2,000

Start

29 Oct 2025

Estimated completion

03 Jul 2028

Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

What is this study about?

This study is about a heart condition called Transthyretin Amyloid Cardiomyopathy, or ATTR-CM. It's a serious condition where a normal body protein, called transthyretin, doesn't fold correctly and builds up in the heart muscle. This buildup makes the heart stiff and can lead to heart failure. There are two main types: one that runs in families (genetic) and another that usually comes with age. Because its symptoms can be like other heart problems, it's often diagnosed late, but new scanning techniques are helping doctors find it earlier.

A new medicine called Acoramidis has been developed to treat ATTR-CM. It works by stopping the protein from misfolding and building up in the heart. This medicine has already been approved for use in both the US and Europe after successful clinical trials showed it was safe and effective. While these trials are very important, doctors also want to know how well new medicines work in real life, when people are taking them as part of their usual care, not just in a study setting.

That's where this study, called ACO-REAL, comes in. Researchers will observe up to 2,000 adults with ATTR-CM across about 20 European countries who are starting to take Acoramidis. This isn't a trial where you'll be given an experimental treatment; you'll be receiving the medicine as part of your normal care. The study aims to understand who is taking Acoramidis, how doctors are using it, its safety, and how it affects patients' heart health, ability to do daily tasks, quality of life, and whether it reduces hospital visits. This information will help improve care for everyone with ATTR-CM.

Key takeaways

This study observes real-world use of Acoramidis for ATTR-CM.
It aims to understand how the medicine works in everyday patient care.
Participation involves sharing medical information from your regular appointments.
You will be receiving Acoramidis as part of your standard treatment.
The findings will help improve understanding and treatment of ATTR-CM.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be able to join this study, you must be at least 18 years old and have a diagnosis of ATTR-CM (either the type that runs in families or the age-related type). You must also be planning to start taking Acoramidis as part of your regular medical treatment, and you'll need to give your permission to be part of the study by signing a consent form.

You cannot join the study if you are already taking part in another medical study that involves receiving an experimental treatment. Also, if there are specific medical reasons listed for not taking Acoramidis (known as contra-indications) that apply to you, you wouldn't be able to participate. Finally, if you're unable to give your own consent to join, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with ATTR-CM?
Are you planning to start taking Acoramidis for your condition?
Are you able to sign a form giving your permission to join?
Are you currently NOT taking part in another experimental medical study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be taking Acoramidis as prescribed by your doctor, just as you would normally. This study is mainly about observing your progress. Your doctors will collect information about your health, how you're doing on the medicine, and your general well-being during your regular clinic visits. They will look at things like your heart check-ups, how well you can move around, and how you feel day-to-day. They'll also note any hospital visits you might have. You won't have extra study visits or receive different treatments than what your doctor would normally recommend. The total duration of your participation will depend on how long your doctor prescribes Acoramidis for you and when the study finishes collecting information.

Potential risks and benefits

The main benefit of joining this study is that the information gathered from your experience will help doctors better understand how Acoramidis works in real life for people with ATTR-CM. This can improve care for other patients in the future. Since you'll be receiving Acoramidis as part of your normal care, there are no additional medical risks from being in the study itself beyond the usual risks associated with taking the medication, which your doctor will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Universitaetsklinik Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What is ATTR-CM?

ATTR-CM is a heart condition where a protein builds up in the heart, making it stiff and weaker over time.

What is Acoramidis?

Acoramidis is a new medicine designed to help stop that protein from building up in the heart for people with ATTR-CM.

Is this a clinical trial where I might get a placebo?

No, this is an observational study. You will be taking Acoramidis as part of your normal medical care, not as an experimental treatment.

What will I have to do if I join?

You won't have extra appointments. Your doctors will simply collect information from your regular check-ups and medical records while you're taking Acoramidis.

Will my information be kept private?

Yes, any information collected would be handled confidentially and used to learn more about the treatment, not to identify you personally.

How to find out more

Bayer Clinical Trials Contact

clinical-trials-contact@bayer.com (+)1-888-84 22937 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.