The Heart Hive - Cardiomyopathy Study
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|ClinicalTrials.gov Identifier: NCT04612296|
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : March 31, 2022
|Condition or disease||Intervention/treatment|
|Cardiomyopathies Myocarditis||Genetic: Research genetic analysis|
This study utilises The Heart Hive, an international, online registry of patients with self-reported clinically diagnosed cardiomyopathy or myocarditis, and people with a family history of cardiomyopathy, enrolled on an on-going basis. Registry participants are invited to enter self-reported demographics and health data relevant to their cardiac diagnosis into The Heart Hive online database.
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||50 Years|
|Official Title:||A Longitudinal Observational Study of Self-reported Cardiomyopathy in the Heart Hive|
|Actual Study Start Date :||November 9, 2019|
|Estimated Primary Completion Date :||November 9, 2024|
|Estimated Study Completion Date :||November 9, 2024|
- Genetic: 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.
- Number of participants with cardiovascular cause of death [ Time Frame: 90 years ]Cardiovascular death
- Number of participants with arrhythmic events [ Time Frame: 90 years ](ventricular fibrillation, unstable sustained ventricular tachycardia, appropriate implantable cardioverter-defibrillator delivered shock, and aborted sudden cardiac death
- Number of participants with major heart failure events [ Time Frame: 90 years ]heart transplantation, left ventricular assist device implantation, unplanned heart failure, hospitalisation
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612296
|Contact: Rachel Buchan, MD PhD||0 207 351 firstname.lastname@example.org|
|Imperial College London||Recruiting|
|London, United Kingdom|
|Contact: Rachel Buchan, MSc email@example.com|
|Principal Investigator:||James Ware||Imperial College London|
|Study Director:||Angharad Roberts||Imperial College London|