<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/NCT04465552</url>
  </required_header>
  <id_info>
    <org_study_id>KCHRF-COVID-19-0001</org_study_id>
    <nct_id>NCT04465552</nct_id>
  </id_info>
  <brief_title>Arrhythmic Manifestations and Management in Hospitalized COVID-19 Patients</brief_title>
  <official_title>Arrhythmic Manifestations and Management Strategies in Hospitalized COVID-19 Patients: Proposal for a Multicenter Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas City Heart Rhythm Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kansas City Heart Rhythm Research Foundation</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>
      Although arrhythmias appear to be common in COVID-19 patients, arrhythmia mechanisms and&#xD;
      characteristics, predisposing factors, incidence of sudden cardiac death and predictors,&#xD;
      therapeutic strategies employed as well as long term outcomes are not well understood. Hence,&#xD;
      we seek to develop a multicenter registry aimed to characterize arrhythmic manifestations,&#xD;
      employed treatment strategies and long-term outcomes among hospitalized COVID-19 patients in&#xD;
      the US.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The novel coronavirus (SARS-CoV-2) and the resulting respiratory tract infection (Coronavirus&#xD;
      Disease 2019 or COVID-19) is a pandemic with over 3 million cases globally and resulting in&#xD;
      &gt;230,000 deaths at the time of this writing. From initial reports in Wuhan, China, viral&#xD;
      progression resulted in over 80,000 cases in January/February 2020 in China. The following&#xD;
      global spread has involved more than 210 countries. Unfortunately, the United States has been&#xD;
      significantly affected, with over 1 million confirmed cases and over 60,000 deaths, the&#xD;
      highest in the world. As this global pandemic continues to rage, cardiovascular, especially&#xD;
      arrhythmic manifestations associated with COVID-19 have become evident. A recent report from&#xD;
      Wuhan, China, noted that 16.7% of hospitalized and 44.4% of ICU patients with COVID-19 had&#xD;
      arrhythmias. Although arrhythmias appear to be common in COVID-19 patients, arrhythmia&#xD;
      mechanisms and characteristics, predisposing factors, incidence of sudden cardiac death and&#xD;
      predictors, therapeutic strategies employed as well as long term outcomes are not well&#xD;
      understood. Hence, we seek to develop a multicenter registry aimed to characterize arrhythmic&#xD;
      manifestations, employed treatment strategies and long-term outcomes among hospitalized&#xD;
      COVID-19 patients in the US.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Actual">January 24, 2021</completion_date>
  <primary_completion_date type="Actual">January 24, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To better characterize arrhythmic manifestations, employed treatment strategies and long- term outcomes in hospitalized COVID-19 patients in the US through a multicenter retrospective chart review.</measure>
    <time_frame>January 1, 2020 - June 30, 2020</time_frame>
    <description>To better characterize arrhythmic manifestations, employed treatment strategies and long- term outcomes in hospitalized COVID-19 patients in the US through a multicenter retrospective chart review.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">666</enrollment>
  <condition>Coronavirus Infections</condition>
  <arm_group>
    <arm_group_label>Hospitalized COVID-19 Patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patients received standard of care treatment during hospitalization</intervention_name>
    <description>All patients admitted with covid-19 will be enrolled and followed for the duration of their hospitalization as well as during outpatient follow for up to 6 months, in those recovered, to assess clinical outcomes.</description>
    <arm_group_label>Hospitalized COVID-19 Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized COVID-19 patients &gt; 18 years of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years of age&#xD;
&#xD;
          -  Hospital admission with COVID-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        ● Age &lt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rakesh Gopinathannair, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas City Heart Rhythm Research Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kansas City Heart Rhythm Institute</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>1. &quot;Coronavirus Cases.&quot; Worldometer, www.worldometers.info/coronavirus/. Accessed March 28, 2020.</citation>
  </reference>
  <reference>
    <citation>2. &quot;Covid-19 Interactive Map.&quot; Johns Hopkins Coronavirus Resource Center, 2020, coronavirus.jhu.edu/map.html. Accessed March 28, 2020.</citation>
  </reference>
  <reference>
    <citation>Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3. Erratum In: Nature. 2020 Dec;588(7836):E6.</citation>
    <PMID>32015507</PMID>
  </reference>
  <reference>
    <citation>4. Centers for Disease Control and Prevention. Interim Clinical Guidance for Management of Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) Infection, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html</citation>
  </reference>
  <reference>
    <citation>Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.</citation>
    <PMID>32031570</PMID>
  </reference>
  <reference>
    <citation>Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.</citation>
    <PMID>32171076</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>September 16, 2021</last_update_submitted>
  <last_update_submitted_qc>September 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Arrhythmic Manifestations</keyword>
  <keyword>Management Strategies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04465552
org study id: KCHRF-COVID-19-0001
nct id: NCT04465552
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although arrhythmias appear to be common in COVID-19 patients, arrhythmia mechanisms and
      characteristics, predisposing factors, incidence of sudden cardiac death and predictors,
      therapeutic strategies employed as well as long term outcomes are not well understood. Hence,
      we seek to develop a multicenter registry aimed to characterize arrhythmic manifestations,
      employed treatment strategies and long-term outcomes among hospitalized COVID-19 patients in
      the US.
The novel coronavirus (SARS-CoV-2) and the resulting respiratory tract infection (Coronavirus
      Disease 2019 or COVID-19) is a pandemic with over 3 million cases globally and resulting in
      >230,000 deaths at the time of this writing. From initial reports in Wuhan, China, viral
      progression resulted in over 80,000 cases in January/February 2020 in China. The following
      global spread has involved more than 210 countries. Unfortunately, the United States has been
      significantly affected, with over 1 million confirmed cases and over 60,000 deaths, the
      highest in the world. As this global pandemic continues to rage, cardiovascular, especially
      arrhythmic manifestations associated with COVID-19 have become evident. A recent report from
      Wuhan, China, noted that 16.7% of hospitalized and 44.4% of ICU patients with COVID-19 had
      arrhythmias. Although arrhythmias appear to be common in COVID-19 patients, arrhythmia
      mechanisms and characteristics, predisposing factors, incidence of sudden cardiac death and
      predictors, therapeutic strategies employed as well as long term outcomes are not well
      understood. Hence, we seek to develop a multicenter registry aimed to characterize arrhythmic
      manifestations, employed treatment strategies and long-term outcomes among hospitalized
      COVID-19 patients in the US.
observational model: Case-Control
time perspective: Retrospective
measure: To better characterize arrhythmic manifestations, employed treatment strategies and long- term outcomes in hospitalized COVID-19 patients in the US through a multicenter retrospective chart review.
time frame: January 1, 2020 - June 30, 2020
description: To better characterize arrhythmic manifestations, employed treatment strategies and long- term outcomes in hospitalized COVID-19 patients in the US through a multicenter retrospective chart review.
arm group label: Hospitalized COVID-19 Patients
intervention type: Other
intervention name: Patients received standard of care treatment during hospitalization
description: All patients admitted with covid-19 will be enrolled and followed for the duration of their hospitalization as well as during outpatient follow for up to 6 months, in those recovered, to assess clinical outcomes.
arm group label: Hospitalized COVID-19 Patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rakesh Gopinathannair, MD
role: Principal Investigator
affiliation: Kansas City Heart Rhythm Research Foundation
facility: 
country: United States
citation: 1. "Coronavirus Cases." Worldometer, www.worldometers.info/coronavirus/. Accessed March 28, 2020.
citation: 2. "Covid-19 Interactive Map." Johns Hopkins Coronavirus Resource Center, 2020, coronavirus.jhu.edu/map.html. Accessed March 28, 2020.
citation: Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3. Erratum In: Nature. 2020 Dec;588(7836):E6.
PMID: 32015507
citation: 4. Centers for Disease Control and Prevention. Interim Clinical Guidance for Management of Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) Infection, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html
citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
PMID: 32031570
citation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
PMID: 32171076
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: No