The Heart Hive - Cardiomyopathy Study

March 24, 2026 updated by: Imperial College London

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eligible adult patients with cardiomyopathy in The Heart Hive registry

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with cardiovascular cause of death
Time Frame: 90 years
Cardiovascular death
90 years
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
90 years
Number of participants with major heart failure events
Time Frame: 90 years
heart transplantation, left ventricular assist device implantation, unplanned heart failure, hospitalisation
90 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: James Ware, Imperial College London
  • Study Director: Angharad Roberts, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2019

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

October 30, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18IC4954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Candidate variants and/or genes, de-identified sequencing data, as well as de-identified high level clinical information may be shared with other clinical laboratories and researchers through databases for the purpose of improving our understanding of the relationship between genetic changes and clinical symptoms. Examples of these types of databases are dbGAP, MatchMaker Exchange, and ClinVar.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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