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Completed

NCT Number: NCT04336384

Impact of Covid-19 in Congenital Heart Disease

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

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Key information

Conditions

Congenital Heart Disease COVID-19 Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronaviridae Infections Coronavirus Infections Heart Defects, Congenital Heart Diseases Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Cardiovascular complications

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

    Cardiovascular complications

  3. Other complications

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

    Other complications

  4. Number of deaths

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

    Number of deaths

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

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

Registry information

Official study title

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

Acronym: COVID-CHD

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2020
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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