NCT04475471

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
16 countries

31 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

July 1, 2020

Last Update Submit

January 25, 2023

Conditions

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (9)

  • Assessment of the patients for major adverse cardiovascular events (MACE)

    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.

    Outcome will be assessed at discharge and 30-day follow-up visit from the hospital admission date.

  • 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]

    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.

    at discharge and 30-day follow-up visits from the hospital admission date.

  • Assessment of the patients for Neurological Outcomes including stroke and Transient Ischemic Attack (TIA)

    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.

    at discharge and 30-day follow-up visits from the hospital admission date.

  • All cause deaths

    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

    any time during the hospital admission and at 30-day follow-up.

  • Impact of COVID-19 vaccination on clinical outcomes - MACE (major adverse cardiovascular events) in COVID-19 hospitalized patients.

    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.

    upto 30 days

  • Persistence of long-COVID Symptoms at 1-month after discharge among survivors of COVID-19 hospitalizations.

    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.

    1-month after hospital discharge

  • Persistence of long-COVID Symptoms at 3-month after discharge among survivors of COVID-19 hospitalizations.

    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.

    3-month after hospital discharge

  • Persistence of long-COVID Symptoms at 6-month after discharge among survivors of COVID-19 hospitalizations.

    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.

    6-month after hospital discharge

  • Persistence of long-COVID Symptoms at 9-12-month after discharge among survivors of COVID-19 hospitalizations.

    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.

    9-12-month after hospital discharge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants will be recruited in any hospital where COVID19 patients are hospitalized. Investigators will invite all WHF members from 100+ countries to identify at least two recruiting centres in their respective countries. Each centre should recruit between 50 and 200 consecutive patients. There is no limit in the number of sites to take part.

You may qualify if:

  • All adults (as locally defined) with confirmed COVID-19 infection who are hospitalized are eligible.

You may not qualify if:

  • Patients for whom investigators are unable to obtain informed consent will be excluded.
  • Patients who are unlikely to stay in the recruiting centre for 30 days (i.e. likely to be transferred)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Hospital de Clinicas of the University

Buenos Aires, Argentina

RECRUITING

Sanatorio GĂ¼emes Hospital

Buenos Aires, Argentina

RECRUITING

Bangladesh Specialized Hospital (BSH)

Dhaka, Bangladesh

RECRUITING

Dhaka Medical College Hospital (DMCH)

Dhaka, Bangladesh

RECRUITING

DNCC Dedicated COVID-19 Hospital

Dhaka, Bangladesh

RECRUITING

Kurmitola General Hospital (KGH)

Dhaka, Bangladesh

RECRUITING

Kuwait Bangladesh Friendship Hospital

Dhaka, Bangladesh

RECRUITING

Popular Medical College Hospital (PMCH)

Dhaka, Bangladesh

RECRUITING

University Clinical Center Republic of Srpska

Srpska, Bosnia and Herzegovina

RECRUITING

Clinica del Occidente, Columbia

BogotĂ¡, Colombia

RECRUITING

Fundacion Valle del Lili

Cali, Colombia

RECRUITING

Komfo Anokye Teaching Hospital

Kumasi, Ghana

RECRUITING

Kumasi South Regional Hospital

Kumasi, Ghana

RECRUITING

Dayanand medical college hospital

Ludhiana, Punjab, India

RECRUITING

AIIMS, New Delhi

Delhi, India

RECRUITING

Apollo Medical College, Jubilee Hills, Hyderabad, India

Hyderabad, India

RECRUITING

Apollol Hopsital,

Hyderabad, India

RECRUITING

AIIMS Jodhpur

Jodhpur, India

RECRUITING

Amin Hospital

Isfahan, Iran

RECRUITING

Khorshid Hospital

Isfahan, Iran

RECRUITING

Kyoto Medical Center

Kyoto, Japan

RECRUITING

National Hospital Organization Kyoto Medical Center, Japan

Kyoto, Japan

RECRUITING

CGTRH-MOMBASA, Kenya

Mombasa, Kenya

RECRUITING

UMMC

Kuala Lumpur, Malaysia

RECRUITING

ISSSTE Clinica Hospital, Guanajuato

Guanajuato City, Mexico

RECRUITING

University College Hospital, Nigeria

Ibadan, Nigeria

RECRUITING

Olabisi Onabanjo University Teaching Hospital (OOUTH)

Sagamu, Nigeria

RECRUITING

Tabba Heart Institute

Karachi, Sindh, Pakistan

RECRUITING

University Hospital Sta Maria, Portugal

Lisbon, Portugal

RECRUITING

Groote Schuur Hospital, South Africa

Cape Town, South Africa

RECRUITING

Fedail Hospital

Khartoum, Sudan

RECRUITING

Levy Mwanawasa University Hospital, Zambia

Lusaka, Zambia

RECRUITING

Related Publications (28)

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    PMID: 32139904BACKGROUND
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    PMID: 32173574BACKGROUND
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    PMID: 32219363BACKGROUND
  • Kwong JC, Schwartz KL, Campitelli MA, Chung H, Crowcroft NS, Karnauchow T, Katz K, Ko DT, McGeer AJ, McNally D, Richardson DC, Rosella LC, Simor A, Smieja M, Zahariadis G, Gubbay JB. Acute Myocardial Infarction after Laboratory-Confirmed Influenza Infection. N Engl J Med. 2018 Jan 25;378(4):345-353. doi: 10.1056/NEJMoa1702090.

    PMID: 29365305BACKGROUND
  • Oudit GY, Kassiri Z, Jiang C, Liu PP, Poutanen SM, Penninger JM, Butany J. SARS-coronavirus modulation of myocardial ACE2 expression and inflammation in patients with SARS. Eur J Clin Invest. 2009 Jul;39(7):618-25. doi: 10.1111/j.1365-2362.2009.02153.x. Epub 2009 May 6.

    PMID: 19453650BACKGROUND
  • Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.

    PMID: 32211816BACKGROUND
  • Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.

    PMID: 32219356BACKGROUND
  • Lippi G, Lavie CJ, Sanchis-Gomar F. Cardiac troponin I in patients with coronavirus disease 2019 (COVID-19): Evidence from a meta-analysis. Prog Cardiovasc Dis. 2020 May-Jun;63(3):390-391. doi: 10.1016/j.pcad.2020.03.001. Epub 2020 Mar 10. No abstract available.

    PMID: 32169400BACKGROUND
  • Yang C, Jin Z. An Acute Respiratory Infection Runs Into the Most Common Noncommunicable Epidemic-COVID-19 and Cardiovascular Diseases. JAMA Cardiol. 2020 Jul 1;5(7):743-744. doi: 10.1001/jamacardio.2020.0934. No abstract available.

    PMID: 32211809BACKGROUND
  • Inciardi RM, Lupi L, Zaccone G, Italia L, Raffo M, Tomasoni D, Cani DS, Cerini M, Farina D, Gavazzi E, Maroldi R, Adamo M, Ammirati E, Sinagra G, Lombardi CM, Metra M. Cardiac Involvement in a Patient With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):819-824. doi: 10.1001/jamacardio.2020.1096.

    PMID: 32219357BACKGROUND
  • Ribeiro AH, Ribeiro MH, Paixao GMM, Oliveira DM, Gomes PR, Canazart JA, Ferreira MPS, Andersson CR, Macfarlane PW, Meira W Jr, Schon TB, Ribeiro ALP. Automatic diagnosis of the 12-lead ECG using a deep neural network. Nat Commun. 2020 Apr 9;11(1):1760. doi: 10.1038/s41467-020-15432-4.

    PMID: 32273514BACKGROUND
  • Alkmim MB, Silva CBG, Figueira RM, Santos DVV, Ribeiro LB, da Paixao MC, Marcolino MS, Paiva JC, Ribeiro AL. Brazilian National Service of Telediagnosis in Electrocardiography. Stud Health Technol Inform. 2019 Aug 21;264:1635-1636. doi: 10.3233/SHTI190571.

    PMID: 31438267BACKGROUND
  • Thienemann F, Pinto F, Grobbee DE, Boehm M, Bazargani N, Ge J, Sliwa K. World Heart Federation Briefing on Prevention: Coronavirus Disease 2019 (COVID-19) in Low-Income Countries. Glob Heart. 2020 Apr 9;15(1):31. doi: 10.5334/gh.778.

  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  • Li B, Yang J, Zhao F, Zhi L, Wang X, Liu L, Bi Z, Zhao Y. Prevalence and impact of cardiovascular metabolic diseases on COVID-19 in China. Clin Res Cardiol. 2020 May;109(5):531-538. doi: 10.1007/s00392-020-01626-9. Epub 2020 Mar 11.

  • 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.

  • Fang L, Karakiulakis G, Roth M. Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection? Lancet Respir Med. 2020 Apr;8(4):e21. doi: 10.1016/S2213-2600(20)30116-8. Epub 2020 Mar 11. No abstract available.

  • Smeeth L, Thomas SL, Hall AJ, Hubbard R, Farrington P, Vallance P. Risk of myocardial infarction and stroke after acute infection or vaccination. N Engl J Med. 2004 Dec 16;351(25):2611-8. doi: 10.1056/NEJMoa041747.

  • Alsahafi AJ, Cheng AC. The epidemiology of Middle East respiratory syndrome coronavirus in the Kingdom of Saudi Arabia, 2012-2015. Int J Infect Dis. 2016 Apr;45:1-4. doi: 10.1016/j.ijid.2016.02.004. Epub 2016 Feb 10.

  • Alhogbani T. Acute myocarditis associated with novel Middle east respiratory syndrome coronavirus. Ann Saudi Med. 2016 Jan-Feb;36(1):78-80. doi: 10.5144/0256-4947.2016.78.

  • Prabhakaran D, Singh K, Kondal D, Raspail L, Mohan B, Kato T, Sarrafzadegan N, Talukder SH, Akter S, Amin MR, Goma F, Gomez-Mesa J, Ntusi N, Inofomoh F, Deora S, Philippov E, Svarovskaya A, Konradi A, Puentes A, Ogah OS, Stanetic B, Issa A, Thienemann F, Juzar D, Zaidel E, Sheikh S, Ojji D, Lam CSP, Ge J, Banerjee A, Newby LK, Ribeiro ALP, Gidding S, Pinto F, Perel P, Sliwa K; WHF COVID-19 Study Collaborators. Cardiovascular Risk Factors and Clinical Outcomes among Patients Hospitalized with COVID-19: Findings from the World Heart Federation COVID-19 Study. Glob Heart. 2022 Jun 15;17(1):40. doi: 10.5334/gh.1128. eCollection 2022.

  • Sliwa K, Singh K, Raspail L, Ojji D, Lam CSP, Thienemann F, Ge J, Banerjee A, Newby LK, Ribeiro ALP, Gidding S, Pinto F, Perel P, Prabhakaran D. The World Heart Federation Global Study on COVID-19 and Cardiovascular Disease. Glob Heart. 2021 Apr 19;16(1):22. doi: 10.5334/gh.950.

  • Thienemann F, Chakafana G, Pineiro D, Pinto FJ, Perel P, Singh K, Eisele JL, Prabhakaran D, Sliwa K. WHF Position Statement on COVID Vaccination. Glob Heart. 2021 Apr 27;16(1):29. doi: 10.5334/gh.1027.

  • Prabhakaran D, Perel P, Roy A, Singh K, Raspail L, Faria-Neto JR, Gidding SS, Ojji D, Hakim F, Newby LK, Stepinska J, Lam CSP, Jobe M, Kraus S, Chuquiure-Valenzuela E, Pineiro D, Khaw KT, Bahiru E, Banerjee A, Narula J, Pinto FJ, Wood DA, Sliwa K. Management of Cardiovascular Disease Patients With Confirmed or Suspected COVID-19 in Limited Resource Settings. Glob Heart. 2020 Jul 1;15(1):44. doi: 10.5334/gh.823.

Related Links

MeSH Terms

Conditions

COVID-19Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • KAREN SILWA, MD, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR
  • Pablo PEREL, MD, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KAVITA SINGH, PhD

CONTACT

DORAIRAJ PRABHAKARAN, MD, DM

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 17, 2020

Study Start

September 1, 2020

Primary Completion

December 30, 2021

Study Completion

December 31, 2023

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Two years after study completion and publication of main study results i.e., Dec 2023
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
More information

Locations