Clinical trial NCT04475471: WORLD HEART FEDERATION (WHF) COVID-19 and Cardiovascular Disease Survey
Official title: WHF COVID-19 and Cardiovascular Disease Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Cardiovascular Diseases
Keywords: SARS-CoV-2
Lead sponsor: Public Health Foundation of India
Sponsor class: OTHER
Collaborators: name: Centre for Chronic Disease Control, India
name: University of Cape Town
name: World Heart Federation, Geneva, Switzerland
First posted: 2020-07-17
Enrollment: 5200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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

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)

Primary outcomes:
measure: Assessment of the patients for major adverse cardiovascular events (MACE)
timeFrame: Outcome will be assessed at discharge and 30-day follow-up visit from the hospital admission date.
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]
timeFrame: at discharge and 30-day follow-up visits from the hospital admission date.
measure: Assessment of the patients for Neurological Outcomes including stroke and Transient Ischemic Attack (TIA)
timeFrame: at discharge and 30-day follow-up visits from the hospital admission date.
measure: All cause deaths
timeFrame: any time during the hospital admission and at 30-day follow-up.
measure: Impact of COVID-19 vaccination on clinical outcomes - MACE (major adverse cardiovascular events) in COVID-19 hospitalized patients.
timeFrame: upto 30 days
measure: Persistence of long-COVID Symptoms at 1-month after discharge among survivors of COVID-19 hospitalizations.
timeFrame: 1-month after hospital discharge
measure: Persistence of long-COVID Symptoms at 3-month after discharge among survivors of COVID-19 hospitalizations.
timeFrame: 3-month after hospital discharge
measure: Persistence of long-COVID Symptoms at 6-month after discharge among survivors of COVID-19 hospitalizations.
timeFrame: 6-month after hospital discharge
measure: Persistence of long-COVID Symptoms at 9-12-month after discharge among survivors of COVID-19 hospitalizations.
timeFrame: 9-12-month after hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital de Clinicas of the University
city: Buenos Aires
country: Argentina
facility: Sanatorio Güemes Hospital
city: Dhaka
country: Bangladesh
facility: Bangladesh Specialized Hospital (BSH)
city: Dhaka
country: Bangladesh
facility: Dhaka Medical College Hospital (DMCH)
city: Dhaka
country: Bangladesh
facility: DNCC Dedicated COVID-19 Hospital
city: Dhaka
country: Bangladesh
facility: Kurmitola General Hospital (KGH)
city: Dhaka
country: Bangladesh
facility: Kuwait Bangladesh Friendship Hospital
city: Dhaka
country: Bangladesh
facility: Popular Medical College Hospital (PMCH)
city: Srpska
country: Bosnia and Herzegovina
facility: University Clinical Center Republic of Srpska
city: Bogotá
country: Colombia
facility: Clinica del Occidente, Columbia
city: Cali
country: Colombia
facility: Fundacion Valle del Lili
city: Kumasi
country: Ghana
facility: Komfo Anokye Teaching Hospital
city: Kumasi
country: Ghana
facility: Kumasi South Regional Hospital
city: Ludhiyana
country: India
facility: Dayanand medical college hospital
state: Punjab
city: Delhi
country: India
facility: AIIMS, New Delhi
city: Hyderabad
country: India
facility: Apollo Medical College, Jubilee Hills, Hyderabad, India
city: Hyderabad
country: India
facility: Apollol Hopsital,
city: Jodhpur
country: India
facility: AIIMS Jodhpur
city: Isfahan
country: Iran, Islamic Republic of
facility: Amin Hospital
city: Isfahan
country: Iran, Islamic Republic of
facility: Khorshid Hospital
city: Kyoto
country: Japan
facility: Kyoto Medical Center
city: Kyoto
country: Japan
facility: National Hospital Organization Kyoto Medical Center, Japan
city: Mombasa
country: Kenya
facility: CGTRH-MOMBASA, Kenya
city: Kuala Lumpur
country: Malaysia
facility: UMMC
city: Guanajuato
country: Mexico
facility: ISSSTE Clinica Hospital, Guanajuato
city: Ibadan
country: Nigeria
facility: University College Hospital, Nigeria
city: Sagamu
country: Nigeria
facility: Olabisi Onabanjo University Teaching Hospital (OOUTH)
city: Karachi
country: Pakistan
facility: Tabba Heart Institute
state: Sindh
city: Lisbon
country: Portugal
facility: University Hospital Sta Maria, Portugal
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital, South Africa
city: Khartoum
country: Sudan
facility: Fedail Hospital
city: Lusaka
country: Zambia
facility: Levy Mwanawasa University Hospital, Zambia
Study officials:
affiliation: University of Cape Town
name: KAREN SILWA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Pablo PEREL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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