Impact of Covid-19 in Congenital Heart Disease

Completed

• Conditions: Congenital Heart Disease; Covid-19

• Registration Number: NCT04336384
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-01
• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-07
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-30
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Covid-19 infection in the overall CHD population	through study completion, an average of 2 weeks	Prevalence of Covid-19 infection in the overall CHD population

Secondary Outcome Measures

Name	Time	Method
Other complications	through study completion, an average of 2 weeks	Other complications
Number of deaths	through study completion, an average of 2 weeks	Number of deaths
Prevalence of Covid-19 infection per CHD sub-group	through study completion, an average of 2 weeks	Prevalence of Covid-19 infection per CHD sub-group
Cardiovascular complications	through study completion, an average of 2 weeks	Cardiovascular complications

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France