Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336384
Recruitment Status : Completed
First Posted : April 7, 2020
Last Update Posted : February 2, 2021
Sponsor:
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
Information provided by (Responsible Party):
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


Condition or disease
Congenital Heart Disease Covid-19

Layout table for study information
Study Type : Observational
Actual Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Peadiatric and adult patient with congenital heart disease and COVID-19
Criteria

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).


Information from the National Library of Medicine

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


Locations
Layout table for location information
France
Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
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
Investigators
Layout table for investigator information
Study Director: Pascal AMEDRO, MD-PhD UH MONTPELLIER
Publications:
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04336384    
Other Study ID Numbers: RECHMPL20_0155
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Congenital heart disease
Covid-19
Adults
Peadiarics
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Heart Diseases
Heart Defects, Congenital
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities