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CompletedNCT04336384COVID-CHDUpdated Feb 2, 2021

Impact of Covid-19 in Congenital Heart Disease

An observational study in Congenital Heart Disease and Covid-19, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Sex
All
01

Study 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

02

Conditions studied

  • Congenital Heart Disease
  • Covid-19

Keywords

  • Congenital heart disease
  • Covid-19
  • Adults
  • Peadiarics
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 5,000 is above the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • Patient with genetic heart disease (cardiomyopathy, hereditary rhythmic disease).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prevalence of Covid-19 infection in the overall CHD population

    Prevalence of Covid-19 infection in the overall CHD population

    Time frame: through study completion, an average of 2 weeks

Secondary outcomes

  1. Prevalence of Covid-19 infection per CHD sub-group

    Prevalence of Covid-19 infection per CHD sub-group

    Time frame: through study completion, an average of 2 weeks

  2. Cardiovascular complications

    Cardiovascular complications

    Time frame: through study completion, an average of 2 weeks

  3. Other complications

    Other complications

    Time frame: through study completion, an average of 2 weeks

  4. Number of deaths

    Number of deaths

    Time frame: through study completion, an average of 2 weeks

07

Study locations

1 site
  • Uh Montpellier
    Montpellier, 34295, France
08

References and documents

Publications

  • Marelli AJ, Mackie AS, Ionescu-Ittu R, Rahme E, Pilote L. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. 2007 Jan 16;115(2):163-72. doi: 10.1161/CIRCULATIONAHA.106.627224. Epub 2007 Jan 8. PubMed 17210844 ↗
  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available. PubMed 32091533 ↗
  • Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. doi: 10.1016/S0140-6736(20)30606-1. Lancet. 2020 Mar 28;395(10229):1038. doi: 10.1016/S0140-6736(20)30638-3. PubMed 32171076 ↗
  • Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031. doi: 10.1001/jamainternmed.2020.1429. PubMed 32167524 ↗

Individual participant data

Plan to share: Undecided — NC

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04336384
Lead 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
Responsible party
Sponsor
First posted
Apr 7, 2020
Start date
Mar 1, 2020
Primary completion
Dec 1, 2020
Completion
Dec 30, 2020
Last update
Feb 2, 2021

Study contacts

Pascal AMEDRO, MD-PhD
study director · UH MONTPELLIER

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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