NCT04475471

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

WHF COVID-19 and Cardiovascular Disease Survey

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,200 (estimated)
• Sponsor: Public Health Foundation of India · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-12-30
• Completion: 2023-12-31
• First posted: 2020-07-17
• Last updated: 2023-01-27

Locations

32 sites across 17 countries: Argentina, Bangladesh, Bosnia and Herzegovina, Colombia, Ghana, India, Iran, Japan, Kenya, Malaysia, Mexico, Nigeria, Pakistan, Portugal, South Africa, Sudan, Zambia