The Heart Hive COVID-19 Study

NCT04468256 | Completed

• 1 other identifier: 20IC6036
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

COVID-19; Cardiomyopathies

Keywords

COVID-19; cardiomyopathy; HCM; DCM

Outcome Measures

Primary Outcomes (2)

• Qualitative measures of exposure, perception of risk, behaviour, and experience during the COVID-19 pandemic.

  Collected from serial online surveys

  2 years

• Health Outcomes

  Hospital admissions and deaths due to COVID-19, incidents of major adverse cardiovascular events

  2 years

Study Arms (2)

Cardiomyopathy

Heart Hive registered participants with self-reported cardiomyopathy

Other: COVID-19 experience surveys

Participants without Heart Disease

Heart Hive registered participants without cardiomyopathy or other heart disease.

Other: COVID-19 experience surveys

Interventions

COVID-19 experience surveys OTHER

Serial online surveys recording experiences of the COVID-19 pandemic.

Cardiomyopathy; Participants without Heart Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, W12 0NN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35086919 DERIVED

Related Links

• The Heart Hive

MeSH Terms

Conditions

COVID-19; Cardiomyopathies

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• James S Ware

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 13, 2020
• Study Start: July 26, 2020
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)