WHF Global Study on CVD and COVID-19

Caused by the coronavirus, SARS-CoV-2, Coronavirus Disease (COVID-19) is known to have particularly deleterious effects on those with underlying conditions such as cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), hypertension (HTN) and diabetes mellitus (DM).  In the general population, some infected patients remain asymptomatic while others can experience mild to moderate respiratory illness, digestive disturbance, and death in severe cases. Shortly after the World Health Organization (WHO) declared the disease a pandemic in March 2020, WHF launched a Global Study on CVD and COVID-19 whose aims are:

• To describe cardiovascular outcomes among patients hospitalized with COVID-19;
• To identify cardiovascular risk factors associated with poor in-hospital prognosis among patients with COVID-19.

As the largest global effort to reflect geographic spread, the data is expected to add to our understanding of disease progression in particularly hard-hit areas of society and the associated medical and social burden. In addition, it will also hopefully inform approaches in clinical practice, health policy and pandemic preparedness. As outlined in the study protocol, “by providing comparable data from countries around the globe, the study will inform the delivery of care for patients with COVID19, with underlying cardiovascular conditions or with cardiovascular complications.”

At the end of the study, an assessment and analysis will be prepared capturing results and methodology which underwent editorial review. The product will be shared in relevant outlets including WHF’s open access Global Heart Journal;  related outputs are expected to include a WHF position statement on COVID vaccines, feature articles and recommendations and insights to support clinical and policy work.

Participation and process

All countries are welcome to participate. A unique aspect of the study is its expansive look at impacts of the disease on patients in low- to middle-income countries.

WHF Members have been proposing hospital sites which can be an unlimited number, with all Members from 100+ countries encouraged to identify at least two recruiting centres in their respective countries, and each centre recruiting between 50 and 200 consecutive patients. In hospitals worldwide, the study will engage COVID-19 adult patients who have provided informed consent and who are likely to stay in the recruiting centre for 30 days, with the target of 5,000 patient participants. Patient follow-up will continue for 30 days, upon death or discharge, whichever occurs first, and detailed outcomes recorded.

Coordination and oversight

The Global Study on CVD and COVID-19 will be coordinated by the Public Health Foundation of India (PHFI) and the Centre for Chronic Disease Control, and conducted in hospitals in low-, middle- and high- income countries. Data will be collected at each site by local researchers and sent to the coordinating centre. Only data outlined on the entry and outcome forms will be collected. Each site will have a research coordinator who will complete in-hospital entry and outcome forms via a secure website throughout the entire study period. Hospital-level data will be collected just once when the hospital joins the study. Details relating to ethical issues such as data handling, informed consent and patient confidentiality are available in the study protocol document in the list below.

WHF’s work is guided by committees reflecting diverse expertise in the field of cardiovascular health. The study is partially funded by Sanofi Pasteur and Pfizer, and is supported by the WHF Science Committee with a team of co-researchers including WHF’s President, Professor Fausto Pinto, and the contributions of the Study Advisory Committee (detailed lists available in the study protocol).

Status of the study –  April, 2021

More than 3,000 patients are registered to participate from sites across 18 countries encompassing all regions. A snapshot of countries includes Argentina, Bangladesh, Bosnia and Herzegovina, Brazil, Chile, Colombia, Georgia, India, Iran, Japan, , Mexico, Pakistan, Portugal, Switzerland, USA and notably, many countries in Africa (Ghana, Kenya, Nigeria, South Africa, Sudan, and Zambia)—a welcome highlight given the relatively low research level related to COVID-19 on the continent. Early evaluation of data for the first 1,000 patients confirm incidence of hypertension and diabetes in patients. The participant target is 5,000 patients based on which a fuller preliminary analysis will be presented at the AHA Congress in November 2021.

This background summary draws from a core set of study documents:

Study Protocol
Ethics Approval
Study Synopsis
Informed Consent Form: English | French | Portuguese | Spanish
Site Questionnaire

To learn more about the study, contact Lana Raspail, lana.raspail@worldheart.org