COVID-19NCT04468256
The Heart Hive COVID-19 Study
An observational study of COVID-19 and Cardiomyopathies, run by Imperial College London at 1 site in United Kingdom.
Trial summary
All patients with heart disease should have the opportunity to participate in research into their condition, to advance knowledge and treatment. The HeartHive COVID-19 study is an international online pilot observational cohort study evaluating the impact and clinical outcomes of the COVID-19 pandemic on subjects… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Cardiomyopathies
- What is being tested?
- COVID-19 experience surveys
- How many people
- 267 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jul 2020to 21 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Heart Hive registry members with cardiomyopathy and subjects without heart disease will be invited to enrol in the Heart Hive COVID-19 study. All registry members have previously given consent to be invited by members of the study team to participate in future studies and understand that this is voluntary. The Heart Hive COVID-19 study may be advertised on social media (including Twitter, Facebook and Instagram). The study team may advertise the study via adverts placed with medical society and patient organisation magazines and websites (e.g. Cardiomyopathy UK and Pumping Marvelous). There is no limit on the number of participants in the study. This reflects the pilot design of the project and the flexibility afforded by the online platform via which the study is delivered.
Who may be able to join
- Adult (age 18 and over) Males or Females
- Capacity to provide informed consent
- Subjects with either:
- A self-reported confirmed diagnosis of cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic cardiomyopathy, restrictive cardiomyopathy, left ventricular non-compaction cardiomyopathy) Or
- No self-reported history of heart disease
- 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)
- Although usually considered a vulnerable group, pregnant women are eligible for this study which is observational and entirely separate from clinical care.
- 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.
About this study
Official title: The Heart Hive COVID-19 Study: A Longitudinal Observational Study of the Impact and Clinical Outcomes of the COVID-19 Pandemic on Individuals With Heart Muscle Disease
All patients with heart disease should have the opportunity to participate in research into their condition, to advance knowledge and treatment.
The HeartHive COVID-19 study is an international online pilot observational cohort study evaluating the impact and clinical outcomes of the COVID-19 pandemic on subjects enrolled in the HeartHive.
Read more
Cardiomyopathies are progressive diseases, and there is a need to better understand what factors affect the chances of developing cardiomyopathy, and how the condition progresses.
The impact of the COVID-19 pandemic on patients with cardiomyopathy has not been explored and represents a critical unmet need. Insights into exposure, healthcare outcomes, behavioural changes and the psychosocial ramifications of the pandemic are required to better understand the health needs of this population during these unprecedented circumstances and to adapt clinical services to meet these.
The study will entail completing serial online surveys during the pandemic.
This study uses The Heart Hive - an international, online registry of patients with self-reported clinically diagnosed cardiomyopathy, and people without heart disease. Participants enrol and upload their own data through the website. It is the second research study that will be offered to registry participants and delivered through The Heart Hive platform.
Read the detailed description
The impact of the COVID-19 pandemic on patients with cardiomyopathy has not been explored and represents a critical unmet need. Insights into exposure, healthcare outcomes, behavioural changes and the psychosocial ramifications of the pandemic are required to better understand the health needs of this population during these unprecedented circumstances and to adapt clinical services to meet these.
The requirements for the population to limit social interaction and stay at home significantly limits conventional research approaches to studying the effect of the pandemic on patients. The Heart Hive platform circumnavigates this by offering an online mechanism to gain insight into the effect of the pandemic in a pre-assembled cohort of patients rapidly and in real-time as the pandemic evolves without any risk to patients.
This study is framed around the following hypotheses:
- Patients with cardiomyopathy who contract COVID-19 are at greater risk or death or hospitalisation than subjects without heart disease.
- Patients with cardiomyopathy perceive themselves to be at enhanced risk and are more likely to be following national recommendations on social restriction measures than subjects without heart disease.
- Patients with cardiomyopathy have experienced interruption to the delivery of their usual cardiology/cardiomyopathy clinical service as a result of the pandemic.
- Patients with cardiomyopathy are less likely to seek medical help due to fear of contracting COVID-19.
- The psychological impact of the pandemic is greater in patients with cardiomyopathy than in subjects without heart disease.
Primary Objectives:
- To conduct serial surveys in patients with cardiomyopathy and subjects without heart disease evaluating the health-related, behavioural and psychosocial impact of the COVID-19 pandemic.
- To use national registries, including NHS Digital, Office for National Statistics (ONS), Hospital Episodes Statistics (HES) and medical records to longitudinally assess hospital admissions and patient mortality from COVID-19 for UK-based participants.
Secondary Objectives:
- To use serial surveys to evaluate the indirect impact of COVID-19 on access to healthcare amongst patients with cardiomyopathy.
The Heart Hive COVID-19 study is an international online pilot observational cohort study evaluating the impact and clinical outcomes of the COVID-19 pandemic on subjects enrolled in the Heart Hive. Patients with heart muscle disease and subjects without heart disease who are Heart Hive registry members are eligible to enrol. Eligible subjects who provide informed consent will be enrolled. The study will entail completing serial online surveys during the pandemic. For subjects who live in the UK who provide consent, health information and outcome data will also be collected from NHS digital, national registries (e.g. ONS, HES, DID) and medical records.
- Conditions
- COVID-19, Cardiomyopathies
- Being tested
- COVID-19 experience surveys
- Keywords
- COVID-19, cardiomyopathy, HCM, DCM
- Medical subject headings
- COVID-19, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 experience surveysOther
Serial online surveys recording experiences of the COVID-19 pandemic.
| Study group | Role | What they receive |
|---|---|---|
| Cardiomyopathy | Heart Hive registered participants with self-reported cardiomyopathy Receives: Other: COVID-19 experience surveys | |
| Participants without Heart Disease | Heart Hive registered participants without cardiomyopathy or other heart disease. Receives: Other: COVID-19 experience surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative measures of exposure, perception of risk, behaviour, and experience during the COVID-19 pandemic.
Collected from serial online surveys
Measured: 2 years
Health Outcomes
Hospital admissions and deaths due to COVID-19, incidents of major adverse cardiovascular events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start26 Jul 2020
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James S Ware, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468256
- Sponsor's protocol ID
- 20IC6036
- Status last verified
- Nov 2022
- First submitted
- 9 Jul 2020
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified data may be shared with other researchers
Publications
Hammersley DJ, Buchan RJ, Lota AS, Mach L, Jones RE, Halliday BP, Tayal U, Meena D, Dehghan A, Tzoulaki I, Baksi AJ, Pantazis A, Roberts AM, Prasad SK, Ware JS. Direct and indirect effect of the COVID-19 pandemic on patients with cardiomyopathy. Open Heart. 2022 Jan;9(1):e001918. doi: 10.1136/openhrt-2021-001918.
PubMed 35086919
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heart Hive COVID-19 Study: A Longitudinal Observational Study of the Impact and Clinical Outcomes of the COVID-19 Pandemic on Individuals With Heart Muscle Disease
- ClinicalTrials.gov ID
- NCT04468256
- Acronym / sponsor ID
- 20IC6036
- Conditions
- COVID-19, Cardiomyopathies
- Keywords
- COVID-19, cardiomyopathy, HCM, DCM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 26 Jul 2020 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 13 Jul 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.
All patients with heart disease should have the opportunity to participate in research into their condition, to advance knowledge and treatment.
The HeartHive COVID-19 study is an international online pilot observational cohort study evaluating the impact and clinical outcomes of the COVID-19 pandemic on subjects enrolled in the HeartHive.
Cardiomyopathies are progressive diseases, and there is a need to better understand what factors affect the chances of developing cardiomyopathy, and how the condition progresses.
The impact of the COVID-19 pandemic on patients with cardiomyopathy has not been explored and represents a critical unmet need. Insights into exposure, healthcare outcomes, behavioural changes and the psychosocial ramifications of the pandemic are required to better understand the health needs of this population during these unprecedented circumstances and to adapt clinical services to meet these.
The study will entail completing serial online surveys during the pandemic.
This study uses The Heart Hive - an international, online registry of patients with self-reported clinically diagnosed cardiomyopathy, and people without heart disease. Participants enrol and upload their own data through the website. It is the second research study that will be offered to registry participants and delivered through The Heart Hive platform.
Detailed description
The impact of the COVID-19 pandemic on patients with cardiomyopathy has not been explored and represents a critical unmet need. Insights into exposure, healthcare outcomes, behavioural changes and the psychosocial ramifications of the pandemic are required to better understand the health needs of this population during these unprecedented circumstances and to adapt clinical services to meet these.
The requirements for the population to limit social interaction and stay at home significantly limits conventional research approaches to studying the effect of the pandemic on patients. The Heart Hive platform circumnavigates this by offering an online mechanism to gain insight into the effect of the pandemic in a pre-assembled cohort of patients rapidly and in real-time as the pandemic evolves without any risk to patients.
This study is framed around the following hypotheses:
- Patients with cardiomyopathy who contract COVID-19 are at greater risk or death or hospitalisation than subjects without heart disease.
- Patients with cardiomyopathy perceive themselves to be at enhanced risk and are more likely to be following national recommendations on social restriction measures than subjects without heart disease.
- Patients with cardiomyopathy have experienced interruption to the delivery of their usual cardiology/cardiomyopathy clinical service as a result of the pandemic.
- Patients with cardiomyopathy are less likely to seek medical help due to fear of contracting COVID-19.
- The psychological impact of the pandemic is greater in patients with cardiomyopathy than in subjects without heart disease.
Primary Objectives:
- To conduct serial surveys in patients with cardiomyopathy and subjects without heart disease evaluating the health-related, behavioural and psychosocial impact of the COVID-19 pandemic.
- To use national registries, including NHS Digital, Office for National Statistics (ONS), Hospital Episodes Statistics (HES) and medical records to longitudinally assess hospital admissions and patient mortality from COVID-19 for UK-based participants.
Secondary Objectives:
- To use serial surveys to evaluate the indirect impact of COVID-19 on access to healthcare amongst patients with cardiomyopathy.
The Heart Hive COVID-19 study is an international online pilot observational cohort study evaluating the impact and clinical outcomes of the COVID-19 pandemic on subjects enrolled in the Heart Hive. Patients with heart muscle disease and subjects without heart disease who are Heart Hive registry members are eligible to enrol. Eligible subjects who provide informed consent will be enrolled. The study will entail completing serial online surveys during the pandemic. For subjects who live in the UK who provide consent, health information and outcome data will also be collected from NHS digital, national registries (e.g. ONS, HES, DID) and medical records.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiomyopathy | – | Other: COVID-19 experience surveysHeart Hive registered participants with self-reported cardiomyopathy |
| Participants without Heart Disease | – | Other: COVID-19 experience surveysHeart Hive registered participants without cardiomyopathy or other heart disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Hive registry members with cardiomyopathy and subjects without heart disease will be invited to enrol in the Heart Hive COVID-19 study. All registry members have previously given consent to be invited by members of the study team to participate in future studies and understand that this is voluntary. The Heart Hive COVID-19 study may be advertised on social media (including Twitter, Facebook and Instagram). The study team may advertise the study via adverts placed with medical society and patient organisation magazines and websites (e.g. Cardiomyopathy UK and Pumping Marvelous). There is no limit on the number of participants in the study. This reflects the pilot design of the project and the flexibility afforded by the online platform via which the study is delivered.
Key inclusion criteria (6 listed)
- Adult (age 18 and over) Males or Females
- Capacity to provide informed consent
- Subjects with either:
- Note: Pregnant women are eligible. This study is observational and entirely separate from clinical care.
Key exclusion criteria (5 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)
- Although usually considered a vulnerable group, pregnant women are eligible for this study which is observational and entirely separate from clinical care.
- 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)
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 |
|---|---|---|
| COVID-19 experience surveysSerial online surveys recording experiences of the COVID-19 pandemic. | Other | Cardiomyopathy, Participants without Heart Disease |
Primary outcome
Qualitative measures of exposure, perception of risk, behaviour, and experience during the COVID-19 pandemic.
Time frame: 2 years
Collected from serial online surveys
Health Outcomes
Time frame: 2 years
Hospital admissions and deaths due to COVID-19, incidents of major adverse cardiovascular events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Derived from this study: PubMed 35086919Hammersley DJ, Buchan RJ, Lota AS, Mach L, Jones RE, Halliday BP, Tayal U, Meena D, Dehghan A, Tzoulaki I, Baksi AJ, Pantazis A, Roberts AM, Prasad SK, Ware JS. Direct and indirect effect of the COVID-19 pandemic on patients with cardiomyopathy. Open Heart. 2022 Jan;9(1):e001918. doi: 10.1136/openhrt-2021-001918.
- The Heart HiveLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only de-identified data may be shared with other researchers
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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. This study is not recruiting at the moment.
James S Ware principal investigator
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 COVID-19 and Cardiomyopathies, 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 5 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: finished, as of the sponsor's last update on 9 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative measures of exposure, perception of risk, behaviour, and experience during the COVID-19 pandemic. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04468256, which also lists 1 linked publication.
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 9 Nov 2022.