Clinical trial NCT04336384: Impact of Covid-19 in Congenital Heart Disease
Official title: Impact of Covid-19 in Congenital Heart Disease - COVID-CHD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Covid-19
Keywords: Congenital heart disease
Covid-19
Adults
Peadiarics
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Pr. Jean-Benoît THAMBO, Bordeaux (président)
name: Dr. Céline GRUNENWALD GRONIER, Strasbourg
name: Dr. Sébastien HASCOET, Le Plessis-Robinson
name: Dr. Adeline BASQUIN, Rennes
name: Dr. Nicolas COMBES, Toulouse
name: Dr. Xavier IRIART, Bordeaux
name: Dr. Daniela LAUX, Paris
name: Dr. Magalie LADOUCEUR, Paris
name: Pr. BERTRAND LEOBON, Toulouse
name: Pr. Caroline OVAERT, Marseille
name: Dr. Karine WARIN-FRESSE, Nantes
name: Alexis BLANC, Montpellier
name: Pr. Roland HENAINE, Lyon
name: Hamouda ABASSI, Montpellier
First posted: 2020-04-07
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peadiatric and adult patient with congenital heart disease and COVID-19

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


Eligibility 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).

Primary outcomes:
measure: Prevalence of Covid-19 infection in the overall CHD population
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: Prevalence of Covid-19 infection per CHD sub-group
timeFrame: through study completion, an average of 2 weeks
measure: Cardiovascular complications
timeFrame: through study completion, an average of 2 weeks
measure: Other complications
timeFrame: through study completion, an average of 2 weeks
measure: Number of deaths
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Pascal AMEDRO, MD-PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.