Active not recruitingOBSERVATIONAL

Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy

This research wants to find new and improved ways to diagnose and treat a heart condition called Dilated Cardiomyopathy (DCM). This could lead to better health for people living with it. The study will look at patients with DCM and other inherited heart diseases from hospitals across England over several years. Participants will give blood samples for a genetic test, and have an MRI scan of their heart. This helps researchers see how genes and changes in the heart muscle affect the disease. The goal is to see if these tests can improve how doctors diagnose DCM and other heart issues, and potentially help develop treatments that are specially designed for each patient.

At a glance

Status

Active not recruiting

Sponsor

Imperial College London

Enrolment target

2,000

Start

09 Jan 2020

Estimated completion

16 Jun 2029

Dilated Cardiomyopathy Cardiovascular Diseases

What is this study about?

This study is all about understanding a heart condition called Dilated Cardiomyopathy (DCM) much better. DCM is when the heart muscle becomes stretched and thin, making it harder to pump blood effectively. This research wants to find new, more accurate ways to diagnose DCM and, importantly, develop better treatments for it. By doing this, the hope is to improve the health and well-being of people with DCM.

Researchers will be looking at people with DCM from various hospitals in England over several years. They'll ask for blood samples to do a detailed genetic test called **whole genome sequencing**. This test looks at all of a person's genes to see if there are any changes that might be linked to heart problems. Participants will also have an **MRI scan of their heart**. This is a special type of scan that can show detailed pictures of the heart muscle, looking for things like scarring, and checking how well the heart is working.

The study aims to discover if these genetic tests and MRI scans can lead to an earlier or more precise diagnosis of DCM. It also wants to see how changes in genes and scarring in the heart might affect how the disease progresses over time. The information gathered from people with DCM might also help doctors learn more about other heart diseases that run in families. The study will also include some people with these other inherited heart conditions to see if the same testing methods could help them too.

Key takeaways

This study aims to find better ways to diagnose and treat Dilated Cardiomyopathy (DCM).
It involves genetic testing (whole genome sequencing) and heart MRI scans.
Participation will help researchers understand how genes and heart changes affect the disease.
The study also looks at other inherited heart conditions in families.
You'll have an initial hospital visit, then complete questionnaires annually for five years.
Your normal medical care will not be affected if you choose to participate or withdraw.

Who may be eligible?

This study is generally open to both men and women of any age. You can take part if you have a confirmed diagnosis of Dilated Cardiomyopathy (DCM). This also includes family members of people with DCM who also have the condition themselves. The study also includes people with other inherited heart conditions and their family members, whether they have the condition or not.

There are some reasons why you might not be able to join. For example, if your DCM was caused by certain drug treatments (like chemotherapy) or specific inflammatory illnesses. You also can't take part if you have a clear history of coronary artery disease (where the arteries supplying the heart are narrowed), or if you have severe issues with heart valves or a severe, uncontrolled high blood pressure.

It's also important that you are able to understand what the study involves and agree to take part yourself. If you are unable to give consent for yourself, you wouldn't be able to join this study.

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.

Do I have a confirmed diagnosis of Dilated Cardiomyopathy (DCM)?
Am I able to understand and agree to take part in the study myself?
Do I currently have severe, untreated high blood pressure?
Have I been diagnosed with coronary artery disease (blocked heart arteries)?
Is my DCM caused by specific drug treatments (like chemotherapy) or inflammatory conditions like sarcoid or lupus?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the hospital for an initial appointment. During this visit, you'll have an MRI scan of your heart, complete some questionnaires about your quality of life, and give blood samples for genetic testing and other analyses. The researchers will also collect some of your existing health information. After this initial visit, the study will continue collecting health information about you over your lifetime from national health records, but this won't require you to do anything else yourself.

You'll be asked to complete questionnaires once a year for five years. If you're already having regular hospital check-ups, you might complete these questionnaires then. Otherwise, you can complete them online or over the phone. Some participants might also be invited for extra tests, like exercise tests or special heart scans, but these are optional, and you don't have to agree to them if you don't want to. If you're having any tissue removed for other medical reasons, you might be asked if the extra tissue can be used for this study, or if you'd be willing to provide an additional small tissue sample. You’ll be asked separately if you agree to any of these additional tests or tissue donations.

Potential risks and benefits

A potential benefit of taking part is contributing to a better understanding of Dilated Cardiomyopathy and other inherited heart conditions, which could lead to improved diagnosis and treatment for future patients. While there are no direct medical advantages to you from participating in the research, you will receive two important medical tests – a genetic test and a heart MRI scan – and the results will be shared with your clinical team. You might experience minor discomfort from blood draws or the MRI scan, but these are generally safe procedures. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (6)

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

Leeds Teaching Hospitals NHS Trust
Verified postcode
Leeds, United Kingdom
Glenfield Hospital
Verified postcode
Leicester, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Verified postcode
Liverpool, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
Verified postcode
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Verified postcode
Oxford, United Kingdom
Southampton General Hospital
Verified postcode
Southampton, United Kingdom

Common questions

What is Dilated Cardiomyopathy (DCM)?

DCM is a heart condition where the heart muscle becomes stretched and thin, making it harder for the heart to pump blood effectively around the body.

What is whole genome sequencing?

This is a detailed genetic test that looks at all of your genes to find any changes that might be linked to heart conditions. It's done using a blood sample.

What does an MRI scan of the heart involve?

An MRI scan uses strong magnets and radio waves to create detailed pictures of your heart, showing its structure and how well it's working. It helps doctors look for scarring or other changes.

Do I have to live in England to participate?

Yes, this study is recruiting patients from hospitals across England.

Will I get my test results?

The results of your genetic test and heart MRI scan will be shared with your clinical care team.