<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/NCT04475471</url>
  </required_header>
  <id_info>
    <org_study_id>RA1413</org_study_id>
    <nct_id>NCT04475471</nct_id>
  </id_info>
  <brief_title>WORLD HEART FEDERATION (WHF) COVID-19 and Cardiovascular Disease Survey</brief_title>
  <acronym>WHF</acronym>
  <official_title>WHF COVID-19 and Cardiovascular Disease Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Public Health Foundation of India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre for Chronic Disease Control, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>World Heart Federation, Geneva, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Public Health Foundation of India</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>
      A global study for a better understanding of the cardiovascular conditions that increase the&#xD;
      risk of developing severe COVID-19, and a better characterization of cardiovascular&#xD;
      complications in hospitalized patients with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 may be cardiotropic in a subset of patients. Both acute and pre-existing CVD impact&#xD;
      outcomes unfavorably. It is possible that one common CVD treatment, medications that impact&#xD;
      ACE-2 function, may impact outcomes either favorably or unfavorably.&#xD;
&#xD;
      However, studies so far have, perforce, been conducted with important limitations (e.g. small&#xD;
      numbers, limited geographical representation, lack of data standardization for risk factors&#xD;
      and outcomes, limited measurement, lack of appropriate adjustment for important confounders,&#xD;
      and missing data). Considering the high global prevalence of CVD and its risk factors (e.g.&#xD;
      hypertension and diabetes) and the suggested link with COVID19 it is urgent to initiate more&#xD;
      robust studies to clarify the many issues early reports have engendered. So that&#xD;
      investigators will conduct a global study for a better understanding of the cardiovascular&#xD;
      conditions that increase the risk of developing severe COVID-19, and a better&#xD;
      characterization of cardiovascular complications in hospitalized patients with COVID-19.&#xD;
&#xD;
      Given the continued increase in the COVID-19 cases worldwide, the study team launched WHF&#xD;
      COVID-19 and CVD Extension Study to continue recruitment of the COVID-19 patients&#xD;
      hospitalized in the selected high-income, middle-income, and low-income countries (sample&#xD;
      size = 3300 patients). This extension study will provide valuable insights on the temporal&#xD;
      trends in clinical characteristics of COVID-19, the specific cause of deaths such as sudden&#xD;
      cardiac death and its relationship with COVID-19 infection, the impact of COVID-19&#xD;
      vaccination on the clinical outcomes at discharge and overall mortality, and anti-microbial&#xD;
      resistance and its association with outcomes in COVID-19 patients.&#xD;
&#xD;
      Further, the study team is also conducting a WHF COVID-19 Long-term follow-up Study in a&#xD;
      sample of 2000 patients from the WHF COVID-19 extension study that aims to determine the&#xD;
      short- (3 month), medium- (6 month) and long-term (9-12 month) sequelae to COVID-19 including&#xD;
      ongoing symptomatology, re-hospitalizations, mortality, impact on physical function and&#xD;
      psycho-social consequences. The long-term sequelae of COVID-19 post hospital discharge are&#xD;
      unknown, and the trajectories are likely to be heterogeneous across countries. This study&#xD;
      will provide invaluable information about the intermediate to long-term effects of COVID-19&#xD;
      and the disease burden and economic impact of COVID-19 on patients with long term sequelae.&#xD;
&#xD;
      Sample Size:&#xD;
&#xD;
        1. WHF COVID-19 and CVD Study (primary cohort): 5200 participants&#xD;
&#xD;
        2. WHF Extension Study: 3300 participants&#xD;
&#xD;
        3. WHF Long term follow-up Study: approx. 2200 participants&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the patients for major adverse cardiovascular events (MACE)</measure>
    <time_frame>Outcome will be assessed at discharge and 30-day follow-up visit from the hospital admission date.</time_frame>
    <description>MACE is defined as the presence of any of the following CVD conditions: myocarditis, arrhythmia, heart failure [including Left ventricular ejection fraction], acute coronary event, as per the hospital admission and discharge records. Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the patients for Pulmonary outcomes including Pulmonary embolism, pneumonia, acute respiratory distress syndrome, need of intensive care - number of days in ICU or ICCU, need of ventilator]</measure>
    <time_frame>at discharge and 30-day follow-up visits from the hospital admission date.</time_frame>
    <description>Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the patients for Neurological Outcomes including stroke and Transient Ischemic Attack (TIA)</measure>
    <time_frame>at discharge and 30-day follow-up visits from the hospital admission date.</time_frame>
    <description>Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All cause deaths</measure>
    <time_frame>any time during the hospital admission and at 30-day follow-up.</time_frame>
    <description>Specific causes of death to be evaluated using CRF including sudden cardiac death, death due to Myocardial infarction, Death due to heart failure, death due to stroke</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of COVID-19 vaccination on clinical outcomes - MACE (major adverse cardiovascular events) in COVID-19 hospitalized patients.</measure>
    <time_frame>upto 30 days</time_frame>
    <description>MACE is defined as the presence of any of the following CVD conditions: myocarditis, arrhythmia, heart failure [including Left ventricular ejection fraction], acute coronary event, as per the hospital admission and discharge records. Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistence of long-COVID Symptoms at 1-month after discharge among survivors of COVID-19 hospitalizations.</measure>
    <time_frame>1-month after hospital discharge</time_frame>
    <description>Questionnaires will be administered telephonically at 1-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistence of long-COVID Symptoms at 3-month after discharge among survivors of COVID-19 hospitalizations.</measure>
    <time_frame>3-month after hospital discharge</time_frame>
    <description>Questionnaires will be administered telephonically at 3-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistence of long-COVID Symptoms at 6-month after discharge among survivors of COVID-19 hospitalizations.</measure>
    <time_frame>6-month after hospital discharge</time_frame>
    <description>Questionnaires will be administered telephonically at 6-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistence of long-COVID Symptoms at 9-12-month after discharge among survivors of COVID-19 hospitalizations.</measure>
    <time_frame>9-12-month after hospital discharge</time_frame>
    <description>Questionnaires will be administered telephonically at 9-12-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.</description>
  </primary_outcome>
  <enrollment type="Anticipated">5200</enrollment>
  <condition>COVID-19</condition>
  <condition>Cardiovascular Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited in any hospital where COVID19 patients are hospitalized.&#xD;
        Investigators will invite all WHF members from 100+ countries to identify at least two&#xD;
        recruiting centres in their respective countries. Each centre should recruit between 50 and&#xD;
        200 consecutive patients. There is no limit in the number of sites to take part.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adults (as locally defined) with confirmed COVID-19 infection who are hospitalized&#xD;
             are eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients for whom investigators are unable to obtain informed consent will be&#xD;
             excluded.&#xD;
&#xD;
          -  Patients who are unlikely to stay in the recruiting centre for 30 days (i.e. likely to&#xD;
             be transferred)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KAREN SILWA, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cape Town</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pablo PEREL, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London School of Hygiene and Tropical Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>KAVITA SINGH, PhD</last_name>
    <phone>9899691150</phone>
    <phone_ext>91</phone_ext>
    <email>kavita@ccdcindia.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>DORAIRAJ PRABHAKARAN, MD, DM</last_name>
    <phone>124-4781400</phone>
    <phone_ext>91</phone_ext>
    <email>dprabhakaran@phfi.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital de Clinicas of the University</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ricardo P. de la Hoz</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sanatorio Güemes Hospital</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ezequiel J. Zaidel</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bangladesh Specialized Hospital (BSH)</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Talukder, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dhaka Medical College Hospital (DMCH)</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Talukder, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>DNCC Dedicated COVID-19 Hospital</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Talukder, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kurmitola General Hospital (KGH)</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Talukder, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kuwait Bangladesh Friendship Hospital</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Talukder, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Popular Medical College Hospital (PMCH)</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Talukder, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Clinical Center Republic of Srpska</name>
      <address>
        <city>Srpska</city>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bojan Stanetiic</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinica del Occidente, Columbia</name>
      <address>
        <city>Bogotá</city>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julián Lugo, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundacion Valle del Lili</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Gomez, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Komfo Anokye Teaching Hospital</name>
      <address>
        <city>Kumasi</city>
        <country>Ghana</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lambert T. Appiah</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kumasi South Regional Hospital</name>
      <address>
        <city>Kumasi</city>
        <country>Ghana</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lambert T. Appiah</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dayanand medical college hospital</name>
      <address>
        <city>Ludhiyana</city>
        <state>Punjab</state>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bishav Mohan, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>AIIMS, New Delhi</name>
      <address>
        <city>Delhi</city>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>nitish. naik, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Apollo Medical College, Jubilee Hills, Hyderabad, India</name>
      <address>
        <city>Hyderabad</city>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahender Kumar, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Apollol Hopsital,</name>
      <address>
        <city>Hyderabad</city>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>C. Venkata S. Ram, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>AIIMS Jodhpur</name>
      <address>
        <city>Jodhpur</city>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Surendra Deora, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Amin Hospital</name>
      <address>
        <city>Isfahan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nizal Sarrafzadegan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Khorshid Hospital</name>
      <address>
        <city>Isfahan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sayed M. Hashemi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kyoto Medical Center</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Koji Hasegawa, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyoto Medical Center, Japan</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Koji Hasegawa, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CGTRH-MOMBASA, Kenya</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ELIJAH OGOLA, PROF.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>UMMC</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hooi Min Lim, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>ISSSTE Clinica Hospital, Guanajuato</name>
      <address>
        <city>Guanajuato</city>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurelio, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University College Hospital, Nigeria</name>
      <address>
        <city>Ibadan</city>
        <country>Nigeria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Okechukwu S Ogah, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Olabisi Onabanjo University Teaching Hospital (OOUTH)</name>
      <address>
        <city>Sagamu</city>
        <country>Nigeria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francisca Inofomoh, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tabba Heart Institute</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sana Sheikh, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Sta Maria, Portugal</name>
      <address>
        <city>Lisbon</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fausto Pinto, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Groote Schuur Hospital, South Africa</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ntobeko Ntusi, Prof</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fedail Hospital</name>
      <address>
        <city>Khartoum</city>
        <country>Sudan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Suliman</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Levy Mwanawasa University Hospital, Zambia</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fastone Goma, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Bangladesh</country>
    <country>Bosnia and Herzegovina</country>
    <country>Colombia</country>
    <country>Ghana</country>
    <country>India</country>
    <country>Iran, Islamic Republic of</country>
    <country>Japan</country>
    <country>Kenya</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Nigeria</country>
    <country>Pakistan</country>
    <country>Portugal</country>
    <country>South Africa</country>
    <country>Sudan</country>
    <country>Zambia</country>
  </location_countries>
  <link>
    <url>https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200316-sitrep-56-covid-19.%20pdf?sfvrsn=9fda7db2_6</url>
    <description>WHO. Coronavirus disease 2019 (COVID-19) situation report-56</description>
  </link>
  <reference>
    <citation>Nguyen JL, Yang W, Ito K, Matte TD, Shaman J, Kinney PL. Seasonal Influenza Infections and Cardiovascular Disease Mortality. JAMA Cardiol. 2016 Jun 1;1(3):274-81. doi: 10.1001/jamacardio.2016.0433.</citation>
    <PMID>27438105</PMID>
  </reference>
  <reference>
    <citation>Madjid M, Miller CC, Zarubaev VV, Marinich IG, Kiselev OI, Lobzin YV, Filippov AE, Casscells SW 3rd. Influenza epidemics and acute respiratory disease activity are associated with a surge in autopsy-confirmed coronary heart disease death: results from 8 years of autopsies in 34,892 subjects. Eur Heart J. 2007 May;28(10):1205-10. doi: 10.1093/eurheartj/ehm035. Epub 2007 Apr 17.</citation>
    <PMID>17440221</PMID>
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  <reference>
    <citation>Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:</citation>
    <PMID>31986264</PMID>
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    <PMID>32489804</PMID>
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  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Public Health Foundation of India</investigator_affiliation>
    <investigator_full_name>Dorairaj Prabhakaran</investigator_full_name>
    <investigator_title>Prof</investigator_title>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Below is the detail of the data to be collected from each patient enrolled in the study:&#xD;
Patient demographics: age, sex, ethnicity, weight/height and education level&#xD;
Clinical history: smoking status, hypertension, diabetes, obesity, heart failure, rheumatic heart disease, chagas, history of Coronary artery disease/ Percutaneous Coronary Interventions/ Coronary artery bypass graft surgery&#xD;
Usual medication (before hospitalization)&#xD;
Clinical characteristics at presentation: confirmed diagnosis of COVID-19, heart rate, blood pressure&#xD;
Tests: ECG, ECHO, troponin, NT-proBNP and other biochemical markers&#xD;
Medication received during hospitalization: cardiovascular and non-cardiovascular medications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Two years after study completion and publication of main study results i.e., Dec 2023</ipd_time_frame>
    <ipd_access_criteria>Two years after study completion and publication of main study results i.e., Dec 2023, and upon request from external researchers being sent to the study PIs and study steering committee for review and approval</ipd_access_criteria>
    <ipd_url>https://www.world-heart-federation.org/</ipd_url>
  </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/NCT04475471
org study id: RA1413
nct id: NCT04475471
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A global study for a better understanding of the cardiovascular conditions that increase the
      risk of developing severe COVID-19, and a better characterization of cardiovascular
      complications in hospitalized patients with COVID-19.
COVID-19 may be cardiotropic in a subset of patients. Both acute and pre-existing CVD impact
      outcomes unfavorably. It is possible that one common CVD treatment, medications that impact
      ACE-2 function, may impact outcomes either favorably or unfavorably.

      However, studies so far have, perforce, been conducted with important limitations (e.g. small
      numbers, limited geographical representation, lack of data standardization for risk factors
      and outcomes, limited measurement, lack of appropriate adjustment for important confounders,
      and missing data). Considering the high global prevalence of CVD and its risk factors (e.g.
      hypertension and diabetes) and the suggested link with COVID19 it is urgent to initiate more
      robust studies to clarify the many issues early reports have engendered. So that
      investigators will conduct a global study for a better understanding of the cardiovascular
      conditions that increase the risk of developing severe COVID-19, and a better
      characterization of cardiovascular complications in hospitalized patients with COVID-19.

      Given the continued increase in the COVID-19 cases worldwide, the study team launched WHF
      COVID-19 and CVD Extension Study to continue recruitment of the COVID-19 patients
      hospitalized in the selected high-income, middle-income, and low-income countries (sample
      size = 3300 patients). This extension study will provide valuable insights on the temporal
      trends in clinical characteristics of COVID-19, the specific cause of deaths such as sudden
      cardiac death and its relationship with COVID-19 infection, the impact of COVID-19
      vaccination on the clinical outcomes at discharge and overall mortality, and anti-microbial
      resistance and its association with outcomes in COVID-19 patients.

      Further, the study team is also conducting a WHF COVID-19 Long-term follow-up Study in a
      sample of 2000 patients from the WHF COVID-19 extension study that aims to determine the
      short- (3 month), medium- (6 month) and long-term (9-12 month) sequelae to COVID-19 including
      ongoing symptomatology, re-hospitalizations, mortality, impact on physical function and
      psycho-social consequences. The long-term sequelae of COVID-19 post hospital discharge are
      unknown, and the trajectories are likely to be heterogeneous across countries. This study
      will provide invaluable information about the intermediate to long-term effects of COVID-19
      and the disease burden and economic impact of COVID-19 on patients with long term sequelae.

      Sample Size:

        1. WHF COVID-19 and CVD Study (primary cohort): 5200 participants

        2. WHF Extension Study: 3300 participants

        3. WHF Long term follow-up Study: approx. 2200 participants
observational model: Cohort
time perspective: Prospective
measure: Assessment of the patients for major adverse cardiovascular events (MACE)
time frame: Outcome will be assessed at discharge and 30-day follow-up visit from the hospital admission date.
description: MACE is defined as the presence of any of the following CVD conditions: myocarditis, arrhythmia, heart failure [including Left ventricular ejection fraction], acute coronary event, as per the hospital admission and discharge records. Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
measure: Assessment of the patients for Pulmonary outcomes including Pulmonary embolism, pneumonia, acute respiratory distress syndrome, need of intensive care - number of days in ICU or ICCU, need of ventilator]
time frame: at discharge and 30-day follow-up visits from the hospital admission date.
description: Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
measure: Assessment of the patients for Neurological Outcomes including stroke and Transient Ischemic Attack (TIA)
time frame: at discharge and 30-day follow-up visits from the hospital admission date.
description: Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
measure: All cause deaths
time frame: any time during the hospital admission and at 30-day follow-up.
description: Specific causes of death to be evaluated using CRF including sudden cardiac death, death due to Myocardial infarction, Death due to heart failure, death due to stroke
measure: Impact of COVID-19 vaccination on clinical outcomes - MACE (major adverse cardiovascular events) in COVID-19 hospitalized patients.
time frame: upto 30 days
description: MACE is defined as the presence of any of the following CVD conditions: myocarditis, arrhythmia, heart failure [including Left ventricular ejection fraction], acute coronary event, as per the hospital admission and discharge records. Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
measure: Persistence of long-COVID Symptoms at 1-month after discharge among survivors of COVID-19 hospitalizations.
time frame: 1-month after hospital discharge
description: Questionnaires will be administered telephonically at 1-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.
measure: Persistence of long-COVID Symptoms at 3-month after discharge among survivors of COVID-19 hospitalizations.
time frame: 3-month after hospital discharge
description: Questionnaires will be administered telephonically at 3-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.
measure: Persistence of long-COVID Symptoms at 6-month after discharge among survivors of COVID-19 hospitalizations.
time frame: 6-month after hospital discharge
description: Questionnaires will be administered telephonically at 6-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.
measure: Persistence of long-COVID Symptoms at 9-12-month after discharge among survivors of COVID-19 hospitalizations.
time frame: 9-12-month after hospital discharge
description: Questionnaires will be administered telephonically at 9-12-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: KAREN SILWA, MD, PhD
role: Principal Investigator
affiliation: University of Cape Town
last name: Pablo PEREL, MD, PhD
role: Principal Investigator
affiliation: London School of Hygiene and Tropical Medicine
last name: KAVITA SINGH, PhD
phone: 9899691150
phone ext: 91
email: kavita@ccdcindia.org
last name: DORAIRAJ PRABHAKARAN, MD, DM
phone: 124-4781400
phone ext: 91
email: dprabhakaran@phfi.org
facility: 
status: Recruiting
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country: Argentina
country: Bangladesh
country: Bosnia and Herzegovina
country: Colombia
country: Ghana
country: India
country: Iran, Islamic Republic of
country: Japan
country: Kenya
country: Malaysia
country: Mexico
country: Nigeria
country: Pakistan
country: Portugal
country: South Africa
country: Sudan
country: Zambia
url: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200316-sitrep-56-covid-19.%20pdf?sfvrsn=9fda7db2_6
description: WHO. Coronavirus disease 2019 (COVID-19) situation report-56
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PMID: 27438105
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citation: Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.
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responsible party type: Principal Investigator
investigator affiliation: Public Health Foundation of India
investigator full name: Dorairaj Prabhakaran
investigator title: Prof
mesh term: COVID-19
mesh term: Cardiovascular Diseases
sharing ipd: Yes
ipd description: Below is the detail of the data to be collected from each patient enrolled in the study:
Patient demographics: age, sex, ethnicity, weight/height and education level
Clinical history: smoking status, hypertension, diabetes, obesity, heart failure, rheumatic heart disease, chagas, history of Coronary artery disease/ Percutaneous Coronary Interventions/ Coronary artery bypass graft surgery
Usual medication (before hospitalization)
Clinical characteristics at presentation: confirmed diagnosis of COVID-19, heart rate, blood pressure
Tests: ECG, ECHO, troponin, NT-proBNP and other biochemical markers
Medication received during hospitalization: cardiovascular and non-cardiovascular medications.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Two years after study completion and publication of main study results i.e., Dec 2023
ipd access criteria: Two years after study completion and publication of main study results i.e., Dec 2023, and upon request from external researchers being sent to the study PIs and study steering committee for review and approval
ipd url: https://www.world-heart-federation.org/