Impact of Covid-19 in Congenital Heart Disease (COVID-CHD)
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|ClinicalTrials.gov Identifier: NCT04336384|
Recruitment Status : Completed
First Posted : April 7, 2020
Last Update Posted : February 2, 2021
The ongoing Coronavirus (Covid-19) pandemic has recently generated the first epidemiological data on populations at risk. Currently, the risk factors, recognized for severe forms of Covid-19 infection, are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory diseases, cardiovascular history (stroke or coronary artery disease), high blood pressure, diabetes, and cancer.
The population of congenital heart disease (CHD) might also be at risk, however, no data is available in this group of patients.
CHD is the leading cause of birth defects, and as a result of recent medical advances, currently the number of adults with CHD exceeds the number of children, with an increasing prevalence of complex CHD. Approximately 200,000 children and 250,000 adults are living with a CHD in France today.
The French Society of Cardiology, coordinator of this study, issued recommendations on March 14, 2020 for the French CHD population on the basis of expert opinions based essentially on the data published in the general population. Nevertheless, there is a need to provide scientific data on the impact of Covid-19 in the pediatric and adult CHD population.
This study aims to assess the morbidity, the mortality and the risk factors associated with Covid-19 in patients with CHD in France
|Condition or disease|
|Congenital Heart Disease Covid-19|
|Study Type :||Observational|
|Actual Enrollment :||5000 participants|
|Official Title:||Impact of Covid-19 in Congenital Heart Disease - COVID-CHD|
|Actual Study Start Date :||March 1, 2020|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||December 30, 2020|
- Prevalence of Covid-19 infection in the overall CHD population [ Time Frame: through study completion, an average of 2 weeks ]Prevalence of Covid-19 infection in the overall CHD population
- Prevalence of Covid-19 infection per CHD sub-group [ Time Frame: through study completion, an average of 2 weeks ]Prevalence of Covid-19 infection per CHD sub-group
- Cardiovascular complications [ Time Frame: through study completion, an average of 2 weeks ]Cardiovascular complications
- Other complications [ Time Frame: through study completion, an average of 2 weeks ]Other complications
- Number of deaths [ Time Frame: through study completion, an average of 2 weeks ]Number of deaths
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336384
|Montpellier, France, 34295|
|Study Director:||Pascal AMEDRO, MD-PhD||UH MONTPELLIER|