Impact of Covid-19 in Congenital Heart Disease (COVID-CHD)

February 1, 2021 updated by: University Hospital, Montpellier

Impact of Covid-19 in Congenital Heart Disease - COVID-CHD

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • UH Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Peadiatric and adult patient with congenital heart disease and COVID-19

Description

Inclusion criteria:

  • Patient with CHD as defined in the international classification ACC-CHD
  • Covid-19 infection over the study period

Exclusion criteria:

- Patient with genetic heart disease (cardiomyopathy, hereditary rhythmic disease).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 2 weeks
Cardiovascular complications
Time Frame: through study completion, an average of 2 weeks
Cardiovascular complications
through study completion, an average of 2 weeks
Other complications
Time Frame: through study completion, an average of 2 weeks
Other complications
through study completion, an average of 2 weeks
Number of deaths
Time Frame: through study completion, an average of 2 weeks
Number of deaths
through study completion, an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Pr. Jean-Benoît THAMBO, Bordeaux (président)
Dr. Céline GRUNENWALD GRONIER, Strasbourg
Dr. Sébastien HASCOET, Le Plessis-Robinson
Dr. Adeline BASQUIN, Rennes
Dr. Nicolas COMBES, Toulouse
Dr. Xavier IRIART, Bordeaux
Dr. Daniela LAUX, Paris
Dr. Magalie LADOUCEUR, Paris
Pr. BERTRAND LEOBON, Toulouse
Pr. Caroline OVAERT, Marseille
Dr. Karine WARIN-FRESSE, Nantes
Alexis BLANC, Montpellier
Pr. Roland HENAINE, Lyon
Hamouda ABASSI, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

December 30, 2020

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (ACTUAL)

April 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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