<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04468256</url>
  </required_header>
  <id_info>
    <org_study_id>20IC6036</org_study_id>
    <nct_id>NCT04468256</nct_id>
  </id_info>
  <brief_title>The Heart Hive COVID-19 Study</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      All patients with heart disease should have the opportunity to participate in research into&#xD;
      their condition, to advance knowledge and treatment.&#xD;
&#xD;
      The HeartHive COVID-19 study is an international online pilot observational cohort study&#xD;
      evaluating the impact and clinical outcomes of the COVID-19 pandemic on subjects enrolled in&#xD;
      the HeartHive.&#xD;
&#xD;
      Cardiomyopathies are progressive diseases, and there is a need to better understand what&#xD;
      factors affect the chances of developing cardiomyopathy, and how the condition progresses.&#xD;
&#xD;
      The impact of the COVID-19 pandemic on patients with cardiomyopathy has not been explored and&#xD;
      represents a critical unmet need. Insights into exposure, healthcare outcomes, behavioural&#xD;
      changes and the psychosocial ramifications of the pandemic are required to better understand&#xD;
      the health needs of this population during these unprecedented circumstances and to adapt&#xD;
      clinical services to meet these.&#xD;
&#xD;
      The study will entail completing serial online surveys during the pandemic.&#xD;
&#xD;
      This study uses The Heart Hive - an international, online registry of patients with&#xD;
      self-reported clinically diagnosed cardiomyopathy, and people without heart disease.&#xD;
      Participants enrol and upload their own data through the website. It is the second research&#xD;
      study that will be offered to registry participants and delivered through The Heart Hive&#xD;
      platform.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The impact of the COVID-19 pandemic on patients with cardiomyopathy has not been explored and&#xD;
      represents a critical unmet need. Insights into exposure, healthcare outcomes, behavioural&#xD;
      changes and the psychosocial ramifications of the pandemic are required to better understand&#xD;
      the health needs of this population during these unprecedented circumstances and to adapt&#xD;
      clinical services to meet these.&#xD;
&#xD;
      The requirements for the population to limit social interaction and stay at home&#xD;
      significantly limits conventional research approaches to studying the effect of the pandemic&#xD;
      on patients. The Heart Hive platform circumnavigates this by offering an online mechanism to&#xD;
      gain insight into the effect of the pandemic in a pre-assembled cohort of patients rapidly&#xD;
      and in real-time as the pandemic evolves without any risk to patients.&#xD;
&#xD;
      This study is framed around the following hypotheses:&#xD;
&#xD;
        1. Patients with cardiomyopathy who contract COVID-19 are at greater risk or death or&#xD;
           hospitalisation than subjects without heart disease.&#xD;
&#xD;
        2. Patients with cardiomyopathy perceive themselves to be at enhanced risk and are more&#xD;
           likely to be following national recommendations on social restriction measures than&#xD;
           subjects without heart disease.&#xD;
&#xD;
        3. Patients with cardiomyopathy have experienced interruption to the delivery of their&#xD;
           usual cardiology/cardiomyopathy clinical service as a result of the pandemic.&#xD;
&#xD;
        4. Patients with cardiomyopathy are less likely to seek medical help due to fear of&#xD;
           contracting COVID-19.&#xD;
&#xD;
        5. The psychological impact of the pandemic is greater in patients with cardiomyopathy than&#xD;
           in subjects without heart disease.&#xD;
&#xD;
      Primary Objectives:&#xD;
&#xD;
        1. To conduct serial surveys in patients with cardiomyopathy and subjects without heart&#xD;
           disease evaluating the health-related, behavioural and psychosocial impact of the&#xD;
           COVID-19 pandemic.&#xD;
&#xD;
        2. To use national registries, including NHS Digital, Office for National Statistics (ONS),&#xD;
           Hospital Episodes Statistics (HES) and medical records to longitudinally assess hospital&#xD;
           admissions and patient mortality from COVID-19 for UK-based participants.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      1. To use serial surveys to evaluate the indirect impact of COVID-19 on access to healthcare&#xD;
      amongst patients with cardiomyopathy.&#xD;
&#xD;
      The Heart Hive COVID-19 study is an international online pilot observational cohort study&#xD;
      evaluating the impact and clinical outcomes of the COVID-19 pandemic on subjects enrolled in&#xD;
      the Heart Hive. Patients with heart muscle disease and subjects without heart disease who are&#xD;
      Heart Hive registry members are eligible to enrol. Eligible subjects who provide informed&#xD;
      consent will be enrolled. The study will entail completing serial online surveys during the&#xD;
      pandemic. For subjects who live in the UK who provide consent, health information and outcome&#xD;
      data will also be collected from NHS digital, national registries (e.g. ONS, HES, DID) and&#xD;
      medical records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 26, 2020</start_date>
  <completion_date type="Actual">July 21, 2022</completion_date>
  <primary_completion_date type="Actual">July 21, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative measures of exposure, perception of risk, behaviour, and experience during the COVID-19 pandemic.</measure>
    <time_frame>2 years</time_frame>
    <description>Collected from serial online surveys</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Outcomes</measure>
    <time_frame>2 years</time_frame>
    <description>Hospital admissions and deaths due to COVID-19, incidents of major adverse cardiovascular events</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">267</enrollment>
  <condition>COVID-19</condition>
  <condition>Cardiomyopathies</condition>
  <arm_group>
    <arm_group_label>Cardiomyopathy</arm_group_label>
    <description>Heart Hive registered participants with self-reported cardiomyopathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants without Heart Disease</arm_group_label>
    <description>Heart Hive registered participants without cardiomyopathy or other heart disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COVID-19 experience surveys</intervention_name>
    <description>Serial online surveys recording experiences of the COVID-19 pandemic.</description>
    <arm_group_label>Cardiomyopathy</arm_group_label>
    <arm_group_label>Participants without Heart Disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Heart Hive registry members with cardiomyopathy and subjects without heart disease will be&#xD;
        invited to enrol in the Heart Hive COVID-19 study. All registry members have previously&#xD;
        given consent to be invited by members of the study team to participate in future studies&#xD;
        and understand that this is voluntary. The Heart Hive COVID-19 study may be advertised on&#xD;
        social media (including Twitter, Facebook and Instagram). The study team may advertise the&#xD;
        study via adverts placed with medical society and patient organisation magazines and&#xD;
        websites (e.g. Cardiomyopathy UK and Pumping Marvelous).&#xD;
&#xD;
        There is no limit on the number of participants in the study. This reflects the pilot&#xD;
        design of the project and the flexibility afforded by the online platform via which the&#xD;
        study is delivered.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (age 18 and over) Males or Females&#xD;
&#xD;
          -  Capacity to provide informed consent&#xD;
&#xD;
          -  Subjects with either:&#xD;
&#xD;
               -  A self-reported confirmed diagnosis of cardiomyopathy (dilated cardiomyopathy,&#xD;
                  hypertrophic cardiomyopathy, arrhythmogenic cardiomyopathy, restrictive&#xD;
                  cardiomyopathy, left ventricular non-compaction cardiomyopathy) Or&#xD;
&#xD;
               -  No self-reported history of heart disease&#xD;
&#xD;
        Note: Pregnant women are eligible. This study is observational and entirely separate from&#xD;
        clinical care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients who lack capacity to consent for themselves Vulnerable groups (e.g. those under&#xD;
        18, prisoners, those in a dependent relationship, the mentally ill)&#xD;
&#xD;
        - Although usually considered a vulnerable group, pregnant women are eligible for this&#xD;
        study which is observational and entirely separate from clinical care.&#xD;
&#xD;
        Patients with a confirmed history of coronary artery disease:&#xD;
&#xD;
          -  who have been informed by their treating physician that their cardiomyopathy is&#xD;
             secondary to their coronary artery disease, or&#xD;
&#xD;
          -  who have undergone previous percutaneous coronary intervention or coronary bypass&#xD;
             surgery History of primary valvular heart disease or congenital heart disease Severe,&#xD;
             untreated or untreatable hypertension (systolic blood pressures routinely &gt;180 mm Hg&#xD;
             and/or diastolic blood pressures &gt;120 mm Hg)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James S Ware</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Imperial College London</name>
      <address>
        <city>London</city>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.thehearthive.org/</url>
    <description>The Heart Hive</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>cardiomyopathy</keyword>
  <keyword>HCM</keyword>
  <keyword>DCM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only de-identified data may be shared with other researchers</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT04468256/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04468256
org study id: 20IC6036
nct id: NCT04468256
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: Qualitative measures of exposure, perception of risk, behaviour, and experience during the COVID-19 pandemic.
time frame: 2 years
description: Collected from serial online surveys
measure: Health Outcomes
time frame: 2 years
description: Hospital admissions and deaths due to COVID-19, incidents of major adverse cardiovascular events
arm group label: Cardiomyopathy
description: Heart Hive registered participants with self-reported cardiomyopathy
arm group label: Participants without Heart Disease
description: Heart Hive registered participants without cardiomyopathy or other heart disease.
intervention type: Other
intervention name: COVID-19 experience surveys
description: Serial online surveys recording experiences of the COVID-19 pandemic.
arm group label: Cardiomyopathy
arm group label: Participants without Heart Disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James S Ware
role: Principal Investigator
affiliation: Imperial College London
facility: 
country: United Kingdom
url: https://www.thehearthive.org/
description: The Heart Hive
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Cardiomyopathies
sharing ipd: No
ipd description: Only de-identified data may be shared with other researchers
provided document: 