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

NCT ID: NCT04475471

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-12-31

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.

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:

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

Conditions

COVID-19; Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Chronic Disease Control, India

OTHER

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: collaborator

World Heart Federation, Geneva, Switzerland

UNKNOWN

Sponsor Role: collaborator

Public Health Foundation of India

OTHER

Sponsor Role: lead

Responsible Party

Dorairaj Prabhakaran

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KAREN SILWA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Pablo PEREL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

Hospital de Clinicas of the University

Buenos Aires, , Argentina

Site Status: RECRUITING

Sanatorio Güemes Hospital

Buenos Aires, , Argentina

Site Status: RECRUITING

Bangladesh Specialized Hospital (BSH)

Dhaka, , Bangladesh

Site Status: RECRUITING

Dhaka Medical College Hospital (DMCH)

Dhaka, , Bangladesh

Site Status: RECRUITING

DNCC Dedicated COVID-19 Hospital

Dhaka, , Bangladesh

Site Status: RECRUITING

Kurmitola General Hospital (KGH)

Dhaka, , Bangladesh

Site Status: RECRUITING

Kuwait Bangladesh Friendship Hospital

Dhaka, , Bangladesh

Site Status: RECRUITING

Popular Medical College Hospital (PMCH)

Dhaka, , Bangladesh

Site Status: RECRUITING

University Clinical Center Republic of Srpska

Srpska, , Bosnia and Herzegovina

Site Status: RECRUITING

Clinica del Occidente, Columbia

Bogotá, , Colombia

Site Status: RECRUITING

Fundacion Valle del Lili

Cali, , Colombia

Site Status: RECRUITING

Komfo Anokye Teaching Hospital

Kumasi, , Ghana

Site Status: RECRUITING

Kumasi South Regional Hospital

Kumasi, , Ghana

Site Status: RECRUITING

Dayanand medical college hospital

Ludhiana, Punjab, India

Site Status: RECRUITING

AIIMS, New Delhi

Delhi, , India

Site Status: RECRUITING

Apollo Medical College, Jubilee Hills, Hyderabad, India

Hyderabad, , India

Site Status: RECRUITING

Apollol Hopsital,

Hyderabad, , India

Site Status: RECRUITING

AIIMS Jodhpur

Jodhpur, , India

Site Status: RECRUITING

Amin Hospital

Isfahan, , Iran

Site Status: RECRUITING

Khorshid Hospital

Isfahan, , Iran

Site Status: RECRUITING

Kyoto Medical Center

Kyoto, , Japan

Site Status: RECRUITING

National Hospital Organization Kyoto Medical Center, Japan

Kyoto, , Japan

Site Status: RECRUITING

CGTRH-MOMBASA, Kenya

Mombasa, , Kenya

Site Status: RECRUITING

UMMC

Kuala Lumpur, , Malaysia

Site Status: RECRUITING

ISSSTE Clinica Hospital, Guanajuato

Guanajuato City, , Mexico

Site Status: RECRUITING

University College Hospital, Nigeria

Ibadan, , Nigeria

Site Status: RECRUITING

Olabisi Onabanjo University Teaching Hospital (OOUTH)

Sagamu, , Nigeria

Site Status: RECRUITING

Tabba Heart Institute

Karachi, Sindh, Pakistan

Site Status: RECRUITING

University Hospital Sta Maria, Portugal

Lisbon, , Portugal

Site Status: RECRUITING

Groote Schuur Hospital, South Africa

Cape Town, , South Africa

Site Status: RECRUITING

Fedail Hospital

Khartoum, , Sudan

Site Status: RECRUITING

Levy Mwanawasa University Hospital, Zambia

Lusaka, , Zambia

Site Status: RECRUITING

Countries

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

Central Contacts

KAVITA SINGH, PhD

Role: CONTACT

kavita@ccdcindia.org

9899691150 ext. 91

DORAIRAJ PRABHAKARAN, MD, DM

Role: CONTACT

dprabhakaran@phfi.org

124-4781400 ext. 91

Facility Contacts

Ricardo P. de la Hoz

Role: primary

Ezequiel J. Zaidel

Role: primary

Talukder, Dr

Role: primary

Talukder, Dr

Role: primary

Talukder, Dr

Role: primary

Talukder, Dr

Role: primary

Talukder, Dr

Role: primary

Talukder, Dr

Role: primary

Bojan Stanetiic

Role: primary

Julián Lugo, Dr

Role: primary

Juan Gomez, Dr

Role: primary

Lambert T. Appiah

Role: primary

Lambert T. Appiah

Role: primary

Bishav Mohan, Dr

Role: primary

nitish. naik, Dr

Role: primary

Mahender Kumar, Dr.

Role: primary

C. Venkata S. Ram, Dr.

Role: primary

Surendra Deora, Dr

Role: primary

Nizal Sarrafzadegan

Role: primary

Sayed M. Hashemi

Role: primary

Koji Hasegawa, Dr

Role: primary

Koji Hasegawa, Dr

Role: primary

ELIJAH OGOLA, PROF.

Role: primary

Hooi Min Lim, Dr

Role: primary

Aurelio, Dr

Role: primary

Okechukwu S Ogah, Dr

Role: primary

Francisca Inofomoh, Dr

Role: primary

Sana Sheikh, Dr

Role: primary

Fausto Pinto, Dr

Role: primary

Ntobeko Ntusi, Prof

Role: primary

Ahmed Suliman

Role: primary

Fastone Goma, Dr

Role: primary

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Related Links

https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200316-sitrep-56-covid-19.%20pdf?sfvrsn=9fda7db2_6

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

Other Identifiers

RA1413

Identifier Type: -

Identifier Source: org_study_id