The Heart Hive COVID-19 Study

November 8, 2022 updated by: Imperial College London

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Patients with cardiomyopathy who contract COVID-19 are at greater risk or death or hospitalisation than subjects without heart disease.
  2. 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.
  3. Patients with cardiomyopathy have experienced interruption to the delivery of their usual cardiology/cardiomyopathy clinical service as a result of the pandemic.
  4. Patients with cardiomyopathy are less likely to seek medical help due to fear of contracting COVID-19.
  5. The psychological impact of the pandemic is greater in patients with cardiomyopathy than in subjects without heart disease.

Primary Objectives:

  1. 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.
  2. 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:

1. 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 Type

Observational

Enrollment (Actual)

267

Contacts and Locations

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

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0NN
        • Imperial College London

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

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:

  • 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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiomyopathy
Heart Hive registered participants with self-reported cardiomyopathy
Other: COVID-19 experience surveys
Serial online surveys recording experiences of the COVID-19 pandemic.
Participants without Heart Disease
Heart Hive registered participants without cardiomyopathy or other heart disease.
Other: COVID-19 experience surveys
Serial online surveys recording experiences of the COVID-19 pandemic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative measures of exposure, perception of risk, behaviour, and experience during the COVID-19 pandemic.
Time Frame: 2 years
Collected from serial online surveys
2 years
Health Outcomes
Time Frame: 2 years
Hospital admissions and deaths due to COVID-19, incidents of major adverse cardiovascular events
2 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 S Ware, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

July 26, 2020

Primary Completion (Actual)

July 21, 2022

Study Completion (Actual)

July 21, 2022

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20IC6036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Only de-identified data may be shared with other researchers

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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