COVID-19WHFNCT04475471
WORLD HEART FEDERATION (WHF) COVID-19 and Cardiovascular Disease Survey
An observational study of COVID-19 and Cardiovascular Diseases, run by Public Health Foundation of India at 32 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Cardiovascular Diseases
- How many people
- 5,200 participants
- Where
- 32 sitesin 17 countries
- Study dates
- 1 Sep 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All adults (as locally defined) with confirmed COVID-19 infection who are hospitalized are eligible.
Who cannot join
- 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)
Trial locations and contacts
32 sites in 17 countries.
32 sites in 17 countries
Bangladesh6 sites, 6 recruiting
- Recruiting
Bangladesh Specialized Hospital (BSH)
Dhaka
Talukder, Dr
- Recruiting
Dhaka Medical College Hospital (DMCH)
Dhaka
Talukder, Dr
- Recruiting
DNCC Dedicated COVID-19 Hospital
Dhaka
Talukder, Dr
- Recruiting
Kurmitola General Hospital (KGH)
Dhaka
Talukder, Dr
- Recruiting
Kuwait Bangladesh Friendship Hospital
Dhaka
Talukder, Dr
- Recruiting
Popular Medical College Hospital (PMCH)
Dhaka
Talukder, Dr
India5 sites, 5 recruiting
- Recruiting
AIIMS, New Delhi
Delhi
nitish. naik, Dr
- Recruiting
Apollo Medical College, Jubilee Hills, Hyderabad, India
Hyderabad
Mahender Kumar, Dr.
- Recruiting
Apollol Hopsital,
Hyderabad
C. Venkata S. Ram, Dr.
- Recruiting
AIIMS Jodhpur
Jodhpur
Surendra Deora, Dr
- Recruiting
Dayanand medical college hospital
Ludhiana, Punjab
Bishav Mohan, Dr
Argentina2 sites, 2 recruiting
- Recruiting
Hospital de Clinicas of the University
Buenos Aires
Ricardo P. de la Hoz
- Recruiting
Sanatorio Güemes Hospital
Buenos Aires
Ezequiel J. Zaidel
Colombia2 sites, 2 recruiting
- Recruiting
Clinica del Occidente, Columbia
Bogotá
Julián Lugo, Dr
- Recruiting
Fundacion Valle del Lili
Cali
Juan Gomez, Dr
Ghana2 sites, 2 recruiting
- Recruiting
Komfo Anokye Teaching Hospital
Kumasi
Lambert T. Appiah
- Recruiting
Kumasi South Regional Hospital
Kumasi
Lambert T. Appiah
Iran2 sites, 2 recruiting
- Recruiting
Amin Hospital
Isfahan
Nizal Sarrafzadegan
- Recruiting
Khorshid Hospital
Isfahan
Sayed M. Hashemi
Japan2 sites, 2 recruiting
- Recruiting
Kyoto Medical Center
Kyoto
Koji Hasegawa, Dr
- Recruiting
National Hospital Organization Kyoto Medical Center, Japan
Kyoto
Koji Hasegawa, Dr
Nigeria2 sites, 2 recruiting
- Recruiting
University College Hospital, Nigeria
Ibadan
Okechukwu S Ogah, Dr
- Recruiting
Olabisi Onabanjo University Teaching Hospital (OOUTH)
Sagamu
Francisca Inofomoh, Dr
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
University Clinical Center Republic of Srpska
Srpska
Bojan Stanetiic
Kenya1 site, 1 recruiting
- Recruiting
CGTRH-MOMBASA, Kenya
Mombasa
ELIJAH OGOLA, PROF.
Mexico1 site, 1 recruiting
- Recruiting
ISSSTE Clinica Hospital, Guanajuato
Guanajuato City
Aurelio, Dr
Pakistan1 site, 1 recruiting
- Recruiting
Tabba Heart Institute
Karachi, Sindh
Sana Sheikh, Dr
Portugal1 site, 1 recruiting
- Recruiting
University Hospital Sta Maria, Portugal
Lisbon
Fausto Pinto, Dr
South Africa1 site, 1 recruiting
- Recruiting
Groote Schuur Hospital, South Africa
Cape Town
Ntobeko Ntusi, Prof
Zambia1 site, 1 recruiting
- Recruiting
Levy Mwanawasa University Hospital, Zambia
Lusaka
Fastone Goma, Dr
About this study
Official title: WHF COVID-19 and Cardiovascular Disease Survey
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.
Read the detailed description
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:
- WHF COVID-19 and CVD Study (primary cohort): 5200 participants
- WHF Extension Study: 3300 participants
- WHF Long term follow-up Study: approx. 2200 participants
- Conditions
- COVID-19, Cardiovascular Diseases
- Keywords
- SARS-CoV-2
- Medical subject headings
- COVID-19, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9-12-month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Sep 2020
- Primary completion30 Dec 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation of India
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Chronic Disease Control, India, University of Cape Town, World Heart Federation, Geneva, Switzerland
- Responsible party
- Principal investigator, Dorairaj Prabhakaran, Public Health Foundation of India
- Investigators
- KAREN SILWA, MD, PhD, Principal investigator, University of Cape TownPablo PEREL, MD, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475471
- Sponsor's protocol ID
- RA1413
- Acronym
- WHF
- Status last verified
- Jan 2023
- First submitted
- 1 Jul 2020
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27438105Madjid 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.
PubMed 17440221Huang 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.
PubMed 31986264Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Zheng 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.
PubMed 32139904Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.
PubMed 32173574Madjid M, Safavi-Naeini P, Solomon SD, Vardeny O. Potential Effects of Coronaviruses on the Cardiovascular System: A Review. JAMA Cardiol. 2020 Jul 1;5(7):831-840. doi: 10.1001/jamacardio.2020.1286.
PubMed 32219363Kwong 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.
PubMed 29365305Oudit 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.
PubMed 19453650Shi 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.
PubMed 32211816Guo 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.
PubMed 32219356Lippi 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.
PubMed 32169400Yang 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.
PubMed 32211809Inciardi 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.
PubMed 32219357Ribeiro 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.
PubMed 32273514
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHF COVID-19 and Cardiovascular Disease Survey
- ClinicalTrials.gov ID
- NCT04475471
- Acronym / sponsor ID
- WHF / RA1413
- Conditions
- COVID-19, Cardiovascular Diseases
- Keywords
- SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,200 participants (estimated)
- Lead sponsor
- Public Health Foundation of IndiaUniversity, hospital or other
- Collaborators
- Centre for Chronic Disease Control, India, University of Cape Town, World Heart Federation, Geneva, Switzerland
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- WHF COVID-19 and CVD Study (primary cohort): 5200 participants
- WHF Extension Study: 3300 participants
- WHF Long term follow-up Study: approx. 2200 participants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All adults (as locally defined) with confirmed COVID-19 infection who are hospitalized are eligible.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
All cause deaths
Time frame: any time during the hospital admission and at 30-day follow-up.
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
Impact of COVID-19 vaccination on clinical outcomes - MACE (major adverse cardiovascular events) in COVID-19 hospitalized patients.
Time frame: upto 30 days
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.
Persistence of long-COVID Symptoms at 1-month after discharge among survivors of COVID-19 hospitalizations.
Time frame: 1-month after hospital discharge
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.
Persistence of long-COVID Symptoms at 3-month after discharge among survivors of COVID-19 hospitalizations.
Time frame: 3-month after hospital discharge
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.
Persistence of long-COVID Symptoms at 6-month after discharge among survivors of COVID-19 hospitalizations.
Time frame: 6-month after hospital discharge
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Background: PubMed 27438105Nguyen 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.
- Background: PubMed 17440221Madjid 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.
- Background: PubMed 31986264Huang 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.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 32139904Zheng 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.
- Background: PubMed 32173574Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.
- Background: PubMed 32219363Madjid M, Safavi-Naeini P, Solomon SD, Vardeny O. Potential Effects of Coronaviruses on the Cardiovascular System: A Review. JAMA Cardiol. 2020 Jul 1;5(7):831-840. doi: 10.1001/jamacardio.2020.1286.
- Background: PubMed 29365305Kwong 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.
- Background: PubMed 19453650Oudit 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.
- Background: PubMed 32211816Shi 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.
- Background: PubMed 32219356Guo 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.
- Background: PubMed 32169400Lippi 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.
- WHO. Coronavirus disease 2019 (COVID-19) situation report-56Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KAREN SILWA, MD, PhD principal investigator
University of Cape Town
Pablo PEREL, MD, PhD principal investigator
London School of Hygiene and Tropical Medicine
32 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Cardiovascular Diseases, run by Public Health Foundation of India at 32 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Bangladesh, India, Argentina, Colombia, Ghana and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KAVITA SINGH, PhD (9899691150 ext. 91, kavita@ccdcindia.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475471, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.