Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy
NCT ID: NCT03843255
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2020-01-09
2027-07-22
Brief Summary
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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.
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Detailed Description
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Patients will attend for a baseline visit for a cardiovascular magnetic resonance (CMR) scan, completion of quality of life questionnaires, collection of blood samples for whole genome sequencing and biomarker analysis, and collection of clinical data. Collection of health information via national registries including Office of National Statistics (ONS) and Hospital Episodes Statistics (HES) will be continued over the patients's lifetime. This will not require any direct contact with the participant.
Recruitment will take place over a 3 year period, with annual completion of questionnaires at patients scheduled hospital visits. If the patient is not scheduled to attend the hospital for regular follow up, then patients may complete the questionnaires via an online system or over the telephone. Patients will be asked to complete questionnaires annually for 5 years. Sub-sets of patients may be invited for additional tests including exercise testing, and stress perfusion scans. These tests will not form part of the core tests for the study, and patients may choose not to have them. Separate informed consent will be obtained from participants for any additional tests.
If patients are having clinical diagnostic tests that involve the removal of tissue, they may be asked to donate any surplus tissue sample, or be asked to provide their consent to collect an additional tissue sample. Separate informed consent will be obtained from participants for donation of additional tissue samples.
Where patients are scheduled to have a CMR scan as part of their routine clinical care, an additional CMR scan for research purposes may not be required.
Children will not be asked to complete any annual questionnaires, health information will be collected via ONS and HES.
Family members of patients who take part in the study will only be asked to donate a blood or saliva sample, and provide consent to collection of their health information via ONS and HES records. They will not have any clinical tests such as CMR.
Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Part 1: Dilated Cardiomyopathy patients
Approximately 1200 patients recruited prospectively from participating sites with a diagnosis of Dilated Cardiomyopathy (DCM). Will also include approximately 800 retrospective patients diagnosed with DCM currently biobanked by the lead site.
Part 1: DCM Cohort
Patients with a confirmed diagnosis of DCM will have samples that undergo whole genome sequencing and biomarker analysis
Part 2: Heritable Cardiovascular Disease
Patients may be recruited with other diagnosed heritable cardiovascular disorders. Family members of patients may be invited to take part in the study. Children may also be approached to take part in the study.
Part 2: Heritable CV Diseases and Family Members
Biomarker analysis will be undertaken on samples
Interventions
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Part 1: DCM Cohort
Patients with a confirmed diagnosis of DCM will have samples that undergo whole genome sequencing and biomarker analysis
Part 2: Heritable CV Diseases and Family Members
Biomarker analysis will be undertaken on samples
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Capacity to provide informed consent
* Patients with a confirmed diagnosis of DCM
* Affected family members of patients meeting diagnostic criteria for DCM
* 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 cardiovascular disease, both affected and unaffected
Exclusion Criteria
* 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
* 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)
99 Years
ALL
No
Sponsors
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British Heart Foundation
OTHER
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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James Ware
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Dr John Greenwood
Role: primary
Prof Gerry McCann
Role: primary
Dr David Wright
Role: primary
Dr Sanjay Prasad
Role: primary
Dr Masliza Mahmod
Role: primary
Dr Charles Peebles
Role: primary
Other Identifiers
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18IC4391
Identifier Type: -
Identifier Source: org_study_id
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