CardiomyopathiesNCT04612296
The Heart Hive - Cardiomyopathy Study
An observational study of Cardiomyopathies and Myocarditis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This is an online registry and database of patients with cardiomyopathy and myocarditis, coupled with an observational study of cardiomyopathies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Myocarditis
- What is being tested?
- Research genetic analysis
- How many people
- 10,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Nov 2019to Sep 2027
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible adult patients with cardiomyopathy in The Heart Hive registry
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London
Rachel Buchan, MSc, info@thehearthive.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiomyopathies, Myocarditis
- Being tested
- Research genetic analysis
- Keywords
- Takotsubo, Dilated cardiomyopathy, hypertrophic cardiomyopathy, ARVC, ACM
- Medical subject headings
- Cardiomyopathies, Myocarditis, Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research genetic analysisGenetic
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with cardiovascular cause of death
Cardiovascular death
Measured: 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
Measured: 90 years
Number of participants with major heart failure events
heart transplantation, left ventricular assist device implantation, unplanned heart failure, hospitalisation
Measured: 90 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start9 Nov 2019
- Primary completion1 Oct 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Ware, Principal investigator, Imperial College LondonAngharad Roberts, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612296
- Sponsor's protocol ID
- 18IC4954
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Observational Study of Self-reported Cardiomyopathy in the Heart Hive
- ClinicalTrials.gov ID
- NCT04612296
- Acronym / sponsor ID
- 18IC4954
- Conditions
- Cardiomyopathies, Myocarditis
- Keywords
- Takotsubo, Dilated cardiomyopathy, hypertrophic cardiomyopathy, ARVC, ACM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 9 Nov 2019 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an online registry and database of patients with cardiomyopathy and myocarditis, coupled with an observational study of cardiomyopathies.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible adult patients with cardiomyopathy in The Heart Hive registry
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research genetic analysisGenetic 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. | Genetic | – |
Primary outcome
Number of participants with cardiovascular cause of death
Time frame: 90 years
Cardiovascular death
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
Number of participants with major heart failure events
Time frame: 90 years
heart transplantation, left ventricular assist device implantation, unplanned heart failure, hospitalisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Ware principal investigator
Imperial College London
Angharad Roberts study director
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Myocarditis, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Buchan, MD PhD (0 207 351 8144, info@thehearthive.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with cardiovascular cause of death (time frame: 90 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.