WORLD HEART FEDERATION (WHF) COVID-19 and Cardiovascular Disease Survey

COVID-19 Clinical Trial

— WHF  

Official title:

WHF COVID-19 and Cardiovascular Disease Survey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475471
• Other study ID #: RA1413
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Public Health Foundation of India
• Contact: KAVITA SINGH, PhD
• Phone: 9899691150
• Email: kavita[@]ccdcindia.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• COVID-19

Locations

Country	Name	City	State
Argentina	Hospital de Clinicas of the University	Buenos Aires
Argentina	Sanatorio Güemes Hospital	Buenos Aires
Bangladesh	Bangladesh Specialized Hospital (BSH)	Dhaka
Bangladesh	Dhaka Medical College Hospital (DMCH)	Dhaka
Bangladesh	DNCC Dedicated COVID-19 Hospital	Dhaka
Bangladesh	Kurmitola General Hospital (KGH)	Dhaka
Bangladesh	Kuwait Bangladesh Friendship Hospital	Dhaka
Bangladesh	Popular Medical College Hospital (PMCH)	Dhaka
Bosnia and Herzegovina	University Clinical Center Republic of Srpska	Srpska
Colombia	Clinica del Occidente, Columbia	Bogotá
Colombia	Fundacion Valle del Lili	Cali
Ghana	Komfo Anokye Teaching Hospital	Kumasi
Ghana	Kumasi South Regional Hospital	Kumasi
India	AIIMS, New Delhi	Delhi
India	Apollo Medical College, Jubilee Hills, Hyderabad, India	Hyderabad
India	Apollol Hopsital,	Hyderabad
India	AIIMS Jodhpur	Jodhpur
India	Dayanand medical college hospital	Ludhiyana	Punjab
Iran, Islamic Republic of	Amin Hospital	Isfahan
Iran, Islamic Republic of	Khorshid Hospital	Isfahan
Japan	Kyoto Medical Center	Kyoto
Japan	National Hospital Organization Kyoto Medical Center, Japan	Kyoto
Kenya	CGTRH-MOMBASA, Kenya	Mombasa
Malaysia	UMMC	Kuala Lumpur
Mexico	ISSSTE Clinica Hospital, Guanajuato	Guanajuato
Nigeria	University College Hospital, Nigeria	Ibadan
Nigeria	Olabisi Onabanjo University Teaching Hospital (OOUTH)	Sagamu
Pakistan	Tabba Heart Institute	Karachi	Sindh
Portugal	University Hospital Sta Maria, Portugal	Lisbon
South Africa	Groote Schuur Hospital, South Africa	Cape Town
Sudan	Fedail Hospital	Khartoum
Zambia	Levy Mwanawasa University Hospital, Zambia	Lusaka

Sponsors (4)

Lead Sponsor	Collaborator
Public Health Foundation of India	Centre for Chronic Disease Control, India, University of Cape Town, World Heart Federation, Geneva, Switzerland

Countries where clinical trial is conducted

Argentina,  Bangladesh,  Bosnia and Herzegovina,  Colombia,  Ghana,  India,  Iran, Islamic Republic of,  Japan,  Kenya,  Malaysia,  Mexico,  Nigeria,  Pakistan,  Portugal,  South Africa,  Sudan,  Zambia, 

References & Publications (28)

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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. — View Citation

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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. Managem — View Citation

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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. Erratum In: Nat Commun. 2020 May 1;11(1):2227. — View Citation

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. — View Citation

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): — View Citation

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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. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   WHO. Coronavirus disease 2019 (COVID-19) situation report-56