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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.
Full 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:
Primary Objectives:
Secondary Objectives:
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.
Enrollment
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Ages
Volunteers
Inclusion criteria
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.
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)
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:
267 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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