RecruitingOBSERVATIONAL

HCMR Re-Imaging Study

This study, called the HCMR Re-Imaging Study, wants to find out what might cause serious heart problems in people with hypertrophic cardiomyopathy (HCM). HCM is a genetic condition where the heart muscle gets thick, making it harder for the heart to pump blood properly and sometimes affecting its electrical system. Researchers are looking back at patients who were part of an earlier study. They particularly want to see if a substance called Gadolinium, which showed up in heart scans during the first study, is linked to a higher risk of heart issues, including sudden heart problems or heart failure. This new study involves follow-up heart scans for these patients to get a clearer picture of how Gadolinium might affect their long-term heart health.

At a glance

Status

Recruiting

Sponsor

Christopher Kramer

Enrolment target

314

Start

30 Mar 2026

Estimated completion

01 Jul 2027

Hypertrophic Cardiomyopathy (HCM)

What is this study about?

This research study, called the HCMR Re-Imaging Study, is designed to help us better understand a heart condition called hypertrophic cardiomyopathy (HCM). In HCM, the heart's pumping muscle becomes thicker than it should be. This thickness can make the heart stiff and less efficient at pumping blood around the body. It can also sometimes affect the heart's natural electrical signals, which control the heartbeat. The main goal of this study is to identify early warning signs or 'predictors' that might tell us which people with HCM are at higher risk of developing more serious heart problems, such as sudden and dangerous fast heart rhythms or heart failure, where the heart can't pump enough blood for the body's needs.

This study is a follow-up to an earlier research project. In that previous study, some patients had a substance called Gadolinium show up in their heart muscle on special scans. Gadolinium is a dye sometimes used to get clearer pictures during an MRI scan. Early findings suggest that if Gadolinium collects in the heart muscle (what doctors call 'late gadolinium enhancement' or LGE), it might mean a higher chance of future heart problems, including sudden cardiac arrest. However, more research is needed to be sure.

The HCMR Re-Imaging Study is therefore inviting people who participated in the original study to come back for new heart scans. By looking at these new scans and comparing them with the earlier results, researchers hope to get a much clearer picture of whether LGE in the heart really does predict who will go on to have serious heart issues. This information could be very important for helping doctors better manage HCM and potentially prevent severe complications in the future.

Key takeaways

This study aims to understand what predicts heart problems in people with HCM.
It's a follow-up for people who were in a previous HCM research study.
The main focus is on repeat heart MRI scans to look for a substance called Gadolinium.
Results could help doctors better manage HCM and prevent serious issues in the future.
No new treatments are given; it's an observational study.
Participation involves mainly one or more heart scans.

Who may be eligible?

To be part of this study, you need to have already taken part in the original "HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy" study.

Generally, participants need to be between 18 and 65 years old. If you have what's called 'obstructive HCM' (meaning there's a blockage to blood flow in your heart), there are specific measurements required from your heart function and you should be in certain health classes (NYHA Class II or III). If you have 'non-obstructive HCM' (meaning there's no blockage), again, specific measurements of your heart function and blood tests are needed.

However, you cannot take part if you have certain other heart conditions or treatments, such as specific kinds of irregular heartbeats (atrial fibrillation) that needed recent treatment, unless it's been stable and well-managed for a while. You also can't participate if you've had fainting spells or very fast heart rhythms related to exercise in the last six months, or if you are pregnant because of the potential risks of the scan dye. Finally, if you have a pacemaker that your heart relies on completely, you won't be able to have the MRI scan for this study.

Quick self-check

I participated in the original "HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy" study.
I am between 18 and 65 years old.
I do not have certain types of irregular heartbeats that have needed recent treatment.
I have not had fainting spells or very fast heart rhythms with exercise in the last 6 months.
I am not pregnant.
I do not have a pacemaker that my heart completely depends on.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This is an 'observational study,' which means you won't be given any new medications or treatments as part of the research. Your participation would mainly involve undergoing a follow-up heart scan, specifically an MRI scan. The main purpose of this scan is to look at your heart muscle again for the presence of Gadolinium, using the same type of dye as before. The research team will then compare these new scan results with your previous ones, and with your ongoing health information. The specific number of visits and the total length of time you'll be involved will depend on the study's plan for follow-up imaging, but it's primarily focused on these re-imaging scans.

Potential risks and benefits

Taking part in this study won't directly improve your health, as it's an observational study and no new treatments are given. However, the information gathered could significantly help future patients with HCM by improving our understanding of the condition and identifying new ways to predict and prevent serious heart problems. The main risk involves the MRI scan and the Gadolinium dye. While generally safe, there's always a very small risk of an allergic reaction to the dye. If you have certain kidney problems, the dye might also be a concern. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (8)

Northwestern
Evanston, United States· Not yet recruiting
Brigham & Women's Hospital
Boston, United States· Not yet recruiting
Tufts Medical Center
Medford, United States· Not yet recruiting
University of Michigan
Ann Arbor, United States· Not yet recruiting
Cleveland Clinic
Cleveland, United States· Not yet recruiting
University of Virginia
Charlottesville, United States· Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom· Not yet recruiting
London Chest Hospital
London, United Kingdom· Not yet recruiting

Common questions

What is hypertrophic cardiomyopathy (HCM)?

HCM is a genetic heart condition where your heart muscle becomes abnormally thick. This can make it harder for your heart to pump blood effectively.

What is Gadolinium and why is it important?

Gadolinium is a special dye sometimes used in MRI scans to get clearer pictures of your heart. In this study, researchers are looking at whether this dye collecting in the heart muscle (called 'late gadolinium enhancement') can predict future heart problems for people with HCM.

Will I receive new treatment if I join this study?

No, this is an observational study, which means no new medications or treatments are given. You will continue to receive your standard medical care from your doctors.

What does 're-imaging' mean?

Re-imaging means having another heart scan (an MRI in this case). The researchers want to compare this new scan with the one you had in the previous study to look for changes over time.

Can I still participate if I have a pacemaker?

If your heart completely relies on your pacemaker, you usually cannot have an MRI scan, so you wouldn't be able to participate in this study.

How to find out more

Gina Duda

gms4x@uvahealth.org 434-924-9553 Official trial record

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