We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

The Heart Hive - Cardiomyopathy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04612296
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : March 31, 2022
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment
Cardiomyopathies Myocarditis Genetic: Research genetic analysis

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 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 50 Years
Official Title: A Longitudinal Observational Study of Self-reported Cardiomyopathy in the Heart Hive
Actual Study Start Date : November 9, 2019
Estimated Primary Completion Date : November 9, 2024
Estimated Study Completion Date : November 9, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Number of participants with cardiovascular cause of death [ Time Frame: 90 years ]
    Cardiovascular death

  2. 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

  3. Number of participants with major heart failure events [ Time Frame: 90 years ]
    heart transplantation, left ventricular assist device implantation, unplanned heart failure, hospitalisation

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible adult patients with dilated or hypertrophic cardiomyopathy in The Heart Hive registry

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612296

Layout table for location contacts
Contact: Rachel Buchan, MD PhD 0 207 351 8144 info@thehearthive.org

Layout table for location information
United Kingdom
Imperial College London Recruiting
London, United Kingdom
Contact: Rachel Buchan, MSc       info@thehearthive.org   
Sponsors and Collaborators
Imperial College London
Layout table for investigator information
Principal Investigator: James Ware Imperial College London
Study Director: Angharad Roberts Imperial College London
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04612296    
Other Study ID Numbers: 18IC4954
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases