NCT04612296

The Heart Hive - Cardiomyopathy Study

A Longitudinal Observational Study of Self-reported Cardiomyopathy in the Heart Hive

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an online registry and database of patients with cardiomyopathy and myocarditis, coupled with an observational study of cardiomyopathies.

Detailed description

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 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 England) 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 cardiomyopathy patients will be recruited to this study from the registry of research willing participants.

Conditions

• Cardiomyopathies
• Myocarditis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-09
• Primary completion: 2026-10-01
• Completion: 2027-09-01
• First posted: 2020-11-02
• Last updated: 2026-03-27

Locations

1 site across 1 country: United Kingdom