AuthorisedTherapeutic use (Phase IV)Interventional

i-Care; Quantitative-imaging in cardiac transthyretin amyloidosis

The i-Care study is focused on a heart condition known as Transthyretin amyloid cardiomyopathy. This condition occurs when abnormal protein builds up in the heart, making it stiff and less able to pump blood effectively. Researchers are using advanced scanning techniques, including PET/CT scans with a low dose of a tracer called Radio-Flu and MIBG scans, to get a very detailed look at the heart. They are especially interested in understanding tiny calcium deposits and how the heart's nerves are working. This information will help them learn more about how the disease progresses and how it affects the heart over time. By gathering this knowledge, the study aims to improve our understanding of Transthyretin amyloid cardiomyopathy, potentially leading to better ways to diagnose and treat it in the future.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

19 Sep 2024

Transthyretin amyloid cardiomyopathy

What is this study about?

The i-Care study is investigating a heart condition called Transthyretin amyloid cardiomyopathy. This condition happens when a specific type of protein, called amyloid, builds up in the heart muscle. Over time, this makes the heart stiff and less able to pump blood properly, which can lead to symptoms like shortness of breath and tiredness. Understanding how this disease affects the heart is really important for developing better ways to help people living with it.

In this study, researchers are using two special types of scans to look closely at the heart. One is called an 18F-sodiumfluoride PET/CT scan, which can help them see very tiny calcium deposits that might build up in the heart muscle. The other is a [123I]MIBG scan, which shows how well the nerves that control the heart are working. By looking at these two things together, scientists hope to get a clearer picture of how Transthyretin amyloid cardiomyopathy develops and changes.

The main goal is to precisely measure these changes in the heart. Researchers will also be looking at other important heart measurements, such as how strongly the heart pumps, its size, and certain chemicals in the blood that signal heart health. They'll also check how well people can walk and their quality of life. All this information will help them learn more about the condition, which could lead to better diagnoses and new treatments in the future.

Key takeaways

The i-Care study is researching a specific heart condition called Transthyretin amyloid cardiomyopathy.
It uses advanced scans to look at tiny calcium deposits and heart nerve function.
The goal is to better understand the disease and improve future diagnosis and treatment.
Participation involves special heart scans, blood tests, and physical assessments.
The study is open to adults aged 18 and older, both men and women, with the condition.

Who may be eligible?

This study is open to adults aged 18 and over. There is no upper age limit, meaning older adults are welcome to participate. Both men and women can take part in this research.

To be considered for the study, you would need to have been diagnosed with Transthyretin amyloid cardiomyopathy. The research team will review your medical history and current health to make sure that the study is a safe and suitable option for you.

If you're interested, the doctors involved in the study will explain everything in detail and check if you meet all the specific requirements. They want to make sure the study is a good fit for you.

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 Transthyretin amyloid cardiomyopathy?
Are you comfortable having special heart scans?
Are you willing to have blood tests and other routine heart checks?
Are you able to participate in follow-up visits?
Are you male or female?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the i-Care study, you would undergo specific medical assessments. The main procedures involve two types of scans: an 18F-sodiumfluoride PET/CT scan and a [123I]MIBG scan. For these scans, you will receive a small, safe injection of a tracing substance (either Radio-Flu for the PET/CT or MIBG for the other scan) that helps the doctors see certain activities in your heart. These are similar to standard medical imaging procedures.

In addition to the scans, you would also have other routine heart checks, such as magnetic resonance imaging (MRI) of your heart, blood tests (to check for heart-related chemicals), and clinical assessments. These clinical checks often include tests like walking for a set distance (6-minute walk test) and answering questionnaires about your quality of life. The study aims to follow how your heart activity changes over a period, so you might have these tests repeated at different times to see any progression. The full duration and number of visits would be explained in detail by the study team.

Potential risks and benefits

Potential benefits of taking part in this study include contributing valuable information that could lead to a better understanding and future treatments for Transthyretin amyloid cardiomyopathy. You will also receive careful monitoring of your heart health. Potential risks are generally low and associated with the scanning procedures, such as minor discomfort from injections or exposure to a very small amount of radiation, similar to other diagnostic scans. The study team will discuss all potential risks and benefits with you in detail. It's important to remember that participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is Transthyretin amyloid cardiomyopathy?

It's a heart condition where an abnormal protein builds up in the heart, making it stiff and harder for it to pump blood effectively.

What are the special scans used in this study?

The study uses PET/CT scans with a substance called Radio-Flu and MIBG scans with another substance called Jobenguaan (123I). These scans help doctors see different aspects of your heart health.

Will I receive new medicine in this study?

This particular study, Phase IV, is focused on learning more about the disease using imaging and observations, rather than testing a new medication. It's about understanding the condition better.

How long will I need to be in the study?

The study aims to observe changes over time, so there will likely be several visits for tests and scans. The exact duration will be explained by the study team.

Are there any side effects from the scans?

The scans involve very low doses of tracing substances. You might feel a slight prick from the injection, but serious side effects are rare. The team will discuss these with you.