Not yet recruitingOBSERVATIONAL

Screening, Characterization, and Longitudinal Follow-up of Patients With Cardiac Amyloidosis

This study is for people who have, or might have, a heart condition called cardiac amyloidosis. This condition happens when unusual protein deposits build up in the heart, leading to heart failure. Doctors want to understand this disease better, how it progresses, and how treatments affect it over time. Participants will have special heart scans (MRIs), breathing tests, and blood tests at the start and then again at 6, 12, and 24 months. These tests will help researchers learn more about how the heart changes, how patients feel, and how well treatments are working. The main goal is to improve understanding of this condition to offer better care in the future.

At a glance

Status

Not yet recruiting

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

200

Start

15 Jun 2026

Estimated completion

31 Dec 2029

Amyloidosis Cardiac Heart Failure Cardiac MRI Spectroscopic Analysis Diagnosis Phenotyping

What is this study about?

This study is focused on a heart condition called cardiac amyloidosis. This happens when abnormal proteins, called amyloid fibrils, build up in the heart. Over time, these deposits can make the heart stiff and less able to pump blood effectively, which can lead to heart failure. Because catching this condition early and finding the right treatment can really make a difference, doctors are keen to learn as much as they can.

This particular study aims to follow people with suspected or confirmed cardiac amyloidosis over two years. By doing so, researchers can carefully watch how the disease changes over time and how different treatments might be helping. They'll be looking at things like how the heart's structure and function change, as well as the patient's general health and well-being. The goal is to gather detailed information to create a clearer picture of this complex condition.

The information collected will help doctors understand more about cardiac amyloidosis, how it progresses, and the effectiveness of treatments in a real-world setting. This improved understanding can then lead to earlier and more accurate diagnoses, as well as better ways to manage the condition in the future, ultimately benefiting patients with cardiac amyloidosis.

Key takeaways

The study aims to understand cardiac amyloidosis better.
It involves regular heart scans (MRI), breathing tests, and blood tests.
Participation lasts for two years.
The study will not affect your standard medical treatment.
Your detailed health information could help others in the future.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who are currently undergoing tests for amyloidosis or already have a confirmed diagnosis of cardiac amyloidosis, but haven't started specific treatment yet.

To be considered, your heart scan (echocardiogram) should show that your heart muscle wall is thicker than usual. Also, your doctor should have some reason to suspect cardiac amyloidosis, based on a list of clues often called "red flags" by heart specialists.

You would not be able to join if you are under 18, cannot have an MRI scan (for example, if you have certain metal implants like an older pacemaker, severe claustrophobia, or are very overweight), or if you are unable to follow the study procedures. You also need to be able to provide your written consent to participate.

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?
Are you currently having tests for amyloidosis or already diagnosed?
Has your heart doctor noticed a thicker heart wall or other signs of amyloidosis?
Are you able to have an MRI scan (e.g., no incompatible metal implants)?
Are you willing and able to attend study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have a series of appointments over two years. At the very beginning (baseline), you'll have a thorough set of tests, which include special heart MRI scans (one while resting and another after some gentle exercise), other imaging called magnetic resonance spectroscopy, breathing tests, and blood tests. These blood tests will check for various markers related to your heart and amyloidosis.

After these initial tests, you'll have routine check-ups with your own doctor at 3 and 9 months. Then, the special study tests, including the heart scans and other functional tests, will be repeated at 6, 12, and 24 months. The total duration of your participation in the special study tests will be two years. It's important to know that any extra information collected during the study won't change your routine medical care; it's purely for research purposes.

Potential risks and benefits

A potential benefit of joining this study is that you would receive very detailed and regular checks of your heart and overall health, which could help your doctors better understand your specific condition. You would also be contributing valuable information that could help improve care for other people with cardiac amyloidosis in the future. Potential risks might include the usual discomfort or minor side effects associated with blood tests or the feeling of claustrophobia in an MRI scanner. The exercise stress MRI might involve some physical exertion. You are free to withdraw from the study at any time without your medical care being affected.

Locations (1)

University Hospital Duesseldorf
Verified postcode
Düsseldorf, Germany

Common questions

What is cardiac amyloidosis?

It's a heart condition where abnormal proteins build up in the heart, making it stiff and affecting its ability to pump blood.

What kind of tests will I have?

You'll have special heart scans (MRI), breathing tests, and blood tests at different times over two years.

How long will I be in the study?

You'll be involved with the specific study tests for two years, with several appointments during that time.

Will my regular treatment change if I join?

No, the study will not change your routine medical treatment; it's just for collecting more information for research.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect your medical care.

How to find out more

Fabian Voß, MD

ctu@med.uni-duesseldorf.de 02118105187 Official trial record

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