The Heart Hive - Cardiomyopathy Study

NCT04612296 | Recruiting

• 1 other identifier: 18IC4954
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiomyopathies; Myocarditis

Keywords

Takotsubo; Dilated cardiomyopathy; hypertrophic cardiomyopathy; ARVC; ACM

Outcome Measures

Primary Outcomes (3)

• Number of participants with cardiovascular cause of death

  Cardiovascular death

  90 years

• 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

• Number of participants with major heart failure events

  heart transplantation, left ventricular assist device implantation, unplanned heart failure, hospitalisation

  90 years

Interventions

Research genetic analysis GENETIC

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible adult patients with cardiomyopathy in The Heart Hive registry

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Cardiomyopathies; Myocarditis; Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• James Ware

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Angharad Roberts

  Imperial College London

  STUDY DIRECTOR

Central Study Contacts

Rachel Buchan, MD PhD

CONTACT

0 207 351 8144; info@thehearthive.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: November 2, 2020
• Study Start: November 9, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

GB (1)