The Heart Hive - Cardiomyopathy Study

Cardiomyopathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612296
• Other study ID #: 18IC4954
• Status: Recruiting
• Start date: November 9, 2019
• Est. completion date: November 9, 2024

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: Rachel Buchan, MD PhD
• Phone: 0 207 351 8144
• Email: info[@]thehearthive.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: November 9, 2024
• Est. primary completion date: November 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiomyopathies
• Myocarditis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with cardiovascular cause of death	Cardiovascular death	90 years
Primary	Number of participants with arrhythmic events	(ventricular fibrillation, unstable sustained ventricular tachycardia, appropriate implantable cardioverter-defibrillator delivered shock, and aborted sudden cardiac death	90 years
Primary	Number of participants with major heart failure events	heart transplantation, left ventricular assist device implantation, unplanned heart failure, hospitalisation	90 years