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 range99 Years

SexALL

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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…

What they're measuring

The incidence of major adverse cardiovascular events over 5 years

Timeframe: 5 years

Incidence of novel gene variants as assessed using whole genome sequencing

Timeframe: 5 years

Trial details

NCT IDNCT03843255

SponsorImperial College London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07-22