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
10000 participants
OBSERVATIONAL
2019-11-09
2024-11-09
Brief Summary
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Detailed Description
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Registry participants with self-reported clinically diagnosed dilated (DCM )or hypertrophic (HCM) cardiomyopathy will be recruited to an observational, prospective study entailing collection of patient-reported baseline demographic data and clinical risk factors, genotyping, and annual collection of follow up data from patients, national registries (NHS Digital) and medical records.
In the pilot phase 100 DCM and 100 HCM patients will be recruited to a validation study. Consent will be sought to access medical information from health care providers in order to compare against and confirm self-reported health information. DNA will be obtained from saliva samples and tested in-house using a panel of clinically validated known Mendelian DCM and HCM genes as a second validation of the accuracy of self-reported diagnosis and to confirm equivalent genetic architecture of DCM and HCM in direct-to-patient recruited cohorts compared to traditional centre of excellence clinic-based recruitments.
Following validation of the approach and once funding is in place for genomic studies, larger numbers of affected DCM and HCM patients will be recruited to this study from the registry of research willing participants.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Research genetic analysis
Genetic analysis of DNA extracted from saliva. Participants can opt in to receive individual results of research genetic analysis for a predefined panel of clinically actionable cardiomyopathy genes.
Eligibility Criteria
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Inclusion Criteria
* Males and Females,
* Capacity to provide informed consent,
* Patients with a confirmed diagnosis of cardiomyopathy or myocarditis,
* People with a family history of cardiomyopathy confirmed in a first or second degree relative.
Note: Pregnant women are eligible. This study is observational and entirely separate from clinical care.
Exclusion Criteria
* Vulnerable groups (e.g. those under 18, prisoners, those in a dependent relationship, the mentally ill).
* Patients with a confirmed history of coronary artery disease:
* who have been informed by their treating physician that their cardiomyopathy is secondary to their coronary artery disease, or
* who have undergone 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)
18 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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James Ware
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Angharad Roberts
Role: STUDY_DIRECTOR
Imperial College London
Locations
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Imperial College London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18IC4954
Identifier Type: -
Identifier Source: org_study_id
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