Active not recruitingOBSERVATIONAL

CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study

This study is looking at a new medicine called ION-682284 for a heart condition called Transthyretin-Mediated Amyloid Cardiomyopathy, or ATTR-CM. In ATTR-CM, a harmful substance called amyloid builds up in the heart, making it harder for the heart to work properly. This particular part of a larger study uses special heart scans, called Magnetic Resonance Imaging (MRI), to measure how much amyloid is in the heart. By doing these scans over time, researchers want to see if the new medicine can reduce the amount of amyloid compared to a dummy treatment (placebo). This will help them understand if the medicine is effective in slowing down or even reversing the heart damage caused by ATTR-CM. It's for people aged 18 to 90.

At a glance

Status

Active not recruiting

Sponsor

Ionis Pharmaceuticals, Inc.

Enrolment target

150

Start

31 Mar 2021

Estimated completion

01 Apr 2026

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

What is this study about?

This research study is specifically designed to understand how a new medicine, called ION-682284, might help people with a heart condition called Transthyretin-Mediated Amyloid Cardiomyopathy, often shortened to ATTR-CM. In this condition, an unwanted substance, known as amyloid, can build up in the heart. This build-up acts like a stiff coating, making it difficult for the heart muscle to pump blood effectively, which can lead to various heart problems.

To see if the new medicine works, this study uses a special type of scan called a Magnetic Resonance Imaging, or MRI scan, of the heart. An MRI is a safe way to take very detailed pictures inside your body. For this study, the MRI will be used to measure how much amyloid is in the heart. By taking these measurements at different times, researchers hope to see if the medicine can reduce the amount of amyloid over time, compared to a placebo (a treatment with no active medicine).

Essentially, this study is a way for doctors to get clear pictures of your heart to check if the new medicine is successful in reducing the harmful amyloid deposits. This information is really important because it helps scientists understand if this new medicine could be a good treatment option for people living with ATTR-CM in the future.

Key takeaways

This study uses special heart MRI scans to look at amyloid build-up.
It's for people with a heart condition called ATTR-CM who are already in a larger drug trial.
The MRI scans help researchers see if a new medicine can reduce amyloid in the heart.
Participation involves having several MRI scans over time.
Your safety is important, and you can stop participating at any time.

Who may be eligible?

To be considered for this study, you must already be taking part in a larger study for the same medicine (ION-682884-CS2). If you are in that study, then you will be checked against some additional criteria for this specific MRI sub-study.

There are some reasons why you might not be able to have an MRI scan. For example, if you have any metal in your body that isn't safe for an MRI, like certain pacemakers or clips, you wouldn't be able to join. Also, if you know you have allergies or bad reactions to the special dye sometimes used in MRI scans, you wouldn't be able to take part.

Other reasons you might not be able to join include if you find it too hard to lie flat on your back for the scan, or if your size means you wouldn't fit comfortably and safely into the MRI machine. Your doctor will also go through a safety checklist to make sure an MRI is suitable 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.

Am I already taking part in the main ION-682884-CS2 medicine study?
Do I have any allergies or bad reactions to dyes used in MRI scans?
Can I lie flat on my back comfortably for a period of time?
Do I have any metal in my body (like certain pacemakers or clips) that might make an MRI unsafe?
Am I between 18 and 90 years old?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, your involvement will mainly revolve around having special heart scans called Cardiac MRI. These scans will help the study doctors see how the amyloid in your heart changes over time. You will need to attend appointments at specific times during the study for these scans. The exact number and timing of these visits will be explained to you in detail. This study does not involve taking a new or different medicine; it collects information through scans for people already participating in the main ION-682884-CS2 study. You will continue to follow the treatment plan from that main study. The total duration of your participation will depend on the schedule of the scans and the main study you are already in.

Potential risks and benefits

Any medical study has potential benefits and risks. A potential benefit of taking part is that the information from your scans could help researchers understand more about how ATTR-CM is affected by the new medicine, which could ultimately lead to better treatments for you and others in the future. The main risks associated with this study involve the MRI scans themselves, such as potential reactions to the contrast dye used (though this is rare) or discomfort from lying still for the scan. Your safety is a top priority, and you will be monitored closely. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (11)

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

Brigham and Women's Hospital
Verified postcode
Boston, United States
Oregon Health and Science University
Verified postcode
Portland, United States
Azienda Ospedaliero - Universitaria Careggi
Verified postcode
Florence, Italy
Azienda Ospedale Università di Padova
Verified postcode
Padova, Italy
Hospital Universitario Puerta de Hierro
Verified postcode
Majadahonda, Spain
Synexus - Scotland Clinical Research Centre
Verified postcode
Bellshill, United Kingdom
Synexus Midlands Clinical Research Centre
Verified postcode
Birmingham, United Kingdom
Synexus - Wales
Verified postcode
Cardiff, United Kingdom
Royal Free London NHS Foundation Trust
Verified postcode
London, United Kingdom
Richmond Pharmacology
Verified postcode
London, United Kingdom
Synexus - Manchester Clinical Research Centre
Verified postcode
Manchester, United Kingdom

Common questions

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed images of organs and structures inside your body, like your heart.

What is amyloid and why is it a problem in the heart?

Amyloid is a build-up of abnormal protein that can make your heart muscle stiff, making it harder for it to pump blood properly.

Will I receive the new medicine in this study?

This study is for people already taking part in a larger study for the new medicine and focuses on using scans to see its effects on the heart.

Are there any reasons I definitely couldn't have an MRI?

Yes, if you have certain metal implants in your body or severe allergies to MRI dyes, you might not be able to have an MRI.

How long would I be in this study?

Your participation length would depend on the schedule for the MRI scans and the duration of the main study you are already enrolled in.