An observational study in COVID-19 and Cardiovascular Diseases, sponsored by Public Health Foundation of India. Status unknown at 32 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-27.
Sponsored by Public Health Foundation of India · Observational
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.
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:
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 5,200 is above the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →Public Health Foundation of India is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Outcome will be assessed at discharge and 30-day follow-up visit from the hospital admission date.
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.
Time frame: at discharge and 30-day follow-up visits from the hospital admission date.
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.
Time frame: at discharge and 30-day follow-up visits from the hospital admission date.
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
Time frame: any time during the hospital admission and at 30-day follow-up.
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.
Time frame: upto 30 days
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.
Time frame: 1-month after hospital discharge
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.
Time frame: 3-month after hospital discharge
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.
Time frame: 6-month after hospital discharge
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.
Time frame: 9-12-month after hospital discharge
Plan to share: Yes — Below is the detail of the data to be collected from each patient enrolled in the study: Patient demographics: age, sex, ethnicity, weight/height and education level Clinical history: smoking status, hypertension, diabetes, obesity, heart failure, rheumatic heart disease, chagas, history of Coronary artery disease/ Percutaneous Coronary Interventions/ Coronary artery bypass graft surgery Usual medication (before hospitalization) Clinical characteristics at presentation: confirmed diagnosis of COVID-19, heart rate, blood pressure Tests: ECG, ECHO, troponin, NT-proBNP and other biochemical markers Medication received during hospitalization: cardiovascular and non-cardiovascular medications.
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: Two years after study completion and publication of main study results i.e., Dec 2023
Access criteria: Two years after study completion and publication of main study results i.e., Dec 2023, and upon request from external researchers being sent to the study PIs and study steering committee for review and approval
Data sharing details ↗ · www.world-heart-federation.org
Ran from Sep 2020 to primary completion in Dec 2021, 15 months.
Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 15 months is close to that.
Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Public Health Foundation of India