Impact of Covid-19 in Congenital Heart Disease

Covid-19 Clinical Trial

— COVID-CHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336384
• Other study ID #: RECHMPL20_0155
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: December 30, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Congenital Heart Disease
• Covid-19
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (15)

Lead Sponsor

Collaborator

University Hospital, Montpellier

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

Country where clinical trial is conducted

France, 

References & Publications (4)

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. Epub 2007 Jan 8. — View 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. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031. — View 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. — View 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. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Covid-19 infection in the overall CHD population	Prevalence of Covid-19 infection in the overall CHD population	through study completion, an average of 2 weeks
Secondary	Prevalence of Covid-19 infection per CHD sub-group	Prevalence of Covid-19 infection per CHD sub-group	through study completion, an average of 2 weeks
Secondary	Cardiovascular complications	Cardiovascular complications	through study completion, an average of 2 weeks
Secondary	Other complications	Other complications	through study completion, an average of 2 weeks
Secondary	Number of deaths	Number of deaths	through study completion, an average of 2 weeks