Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy (NCT03843255) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy
United Kingdom2,000 participantsStarted 2020-01-09
Plain-language summary
Finding new ways to diagnose and treat Dilated Cardiomyopathy (DCM) could improve the health and well-being of patients with this condition. The main aim of this research study is to help develop better ways of diagnosing and treating patients with DCM. The information that is collected may help develop tailored treatments for patients with this disease in the future. This research study will recruit patients with DCM from a number of centres across England and follow their health over a period of years. Patients will give some blood samples for a type of genetic test called whole genome sequencing (WGS) to look for genetic changes. Patients will also have a magnetic resonance imaging (MRI) scan of their heart to look for any changes in the heart such as scarring, and check their heart function. The aim of this study is to discover if using WGS and MRI can improve the diagnosis of DCM. Another aim of the study is to look at how genetic changes and scarring in the heart may affect the progress of the disease.
Studying patients with DCM may also help the investigators learn more about diagnosing and treating other diseases of the heart. The second aim of this study is to see whether using WGS and MRI scanning can also be useful in other types of heart diseases which might be affected by genetic changes or scarring in the heart.
Who can participate
Age range
99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
PART 1
Inclusion Criteria:
* Male or female participants of any age
* Capacity to provide informed consent
* Patients with a confirmed diagnosis of DCM
* Affected family members of patients meeting diagnostic criteria for DCM
Exclusion Criteria:
* DCM attributed to chemotoxicity (from chemotherapeutic agents, drugs of abuse)
* DCM attributed to systemic inflammatory myopathies (eg sarcoid, systemic lupus erythematosus)
* Patients who lack capacity to consent for themselves
* Patients with a confirmed history of coronary artery disease, assessed using standard UK clinical practice guidelines, defined as one or more of the following:-
* \>50% narrowing, any major epicardial coronary artery on invasive or computed tomography coronary angiography
* CMR suggestive of previous myocardial infarction of ≥2 segments of ≥50% infarction of the LV wall
* Previous percutaneous coronary intervention or coronary bypass surgery
* History of primary valvular heart disease or congenital heart disease
* Severe, untreated or untreatable hypertension (systolic blood pressures routinely \>180 mm Hg and/or diastolic blood pressures \>120 mm Hg)
PART 2
Inclusion Criteria:
* Males or females of any age
* Capacity to provide informed consent
* Patients with hypokinetic non-dilated cardiomyopathy, or
* Family members of DCM patients with possible or probable DCM or
* Patients with a confirmed diagnosis of heritable cardiovascular disease or
* Family members of patients with heritable card…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of major adverse cardiovascular events over 5 years
Timeframe: 5 years
2
Incidence of novel gene variants as assessed using whole genome sequencing