Registry for patients with cardiomyopathy and myocarditis
A Longitudinal Observational Study of Self-reported Cardiomyopathy in the Heart Hive
Imperial College London · NCT04612296
This study is trying to gather health information from people with cardiomyopathy or myocarditis to better understand these conditions and their genetics.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT04612296 on ClinicalTrials.gov |
What this trial studies
This study utilizes The Heart Hive, an international online registry for patients with clinically diagnosed cardiomyopathy or myocarditis, as well as those with a family history of these conditions. Participants will provide self-reported demographic and health data, which will be collected and analyzed over time. The study will recruit patients with dilated (DCM) and hypertrophic (HCM) cardiomyopathy for an observational study that includes genetic analysis and validation of self-reported diagnoses against medical records. The pilot phase aims to validate the approach with 200 patients, focusing on the genetic architecture of these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with a confirmed diagnosis of cardiomyopathy or myocarditis, as well as those with a family history of cardiomyopathy.
Not a fit: Patients with a confirmed history of coronary artery disease or primary valvular heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of cardiomyopathy and myocarditis, leading to improved diagnosis and treatment options for patients.
How similar studies have performed: Other studies utilizing patient registries and genetic analysis have shown promise in advancing understanding and treatment of cardiomyopathies, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (age 18 and over), * 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: * Patients who lack capacity to consent for themselves, * 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)
Where this trial is running
London
- Imperial College London — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: James Ware — Imperial College London
- Study coordinator: Rachel Buchan, MD PhD
- Email: info@thehearthive.org
- Phone: 0 207 351 8144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiomyopathies, Myocarditis, Takotsubo, Dilated cardiomyopathy, hypertrophic cardiomyopathy, ARVC, ACM