Impact of Covid-19 in Congenital Heart Disease

NCT04336384 | Completed

• 1 other identifier: RECHMPL20_0155
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Conditions

Congenital Heart Disease; Covid-19

Keywords

Congenital heart disease; Covid-19; Adults; Peadiarics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Prevalence of Covid-19 infection per CHD sub-group

  through study completion, an average of 2 weeks

• Cardiovascular complications

  through study completion, an average of 2 weeks

• Other complications

  through study completion, an average of 2 weeks

• Number of deaths

  through study completion, an average of 2 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Related 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. doi: 10.1161/CIRCULATIONAHA.106.627224. Epub 2007 Jan 8.

  PMID: 17210844 BACKGROUND

• 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.

  PMID: 32091533 BACKGROUND

• 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.

  PMID: 32171076 BACKGROUND

• 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.

  PMID: 32167524 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; COVID-19

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pascal AMEDRO, MD-PhD

  UH MONTPELLIER

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 7, 2020
• Study Start: March 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2020
• Last Updated: February 2, 2021

Record last verified: 2020-03

Locations

FR (1)