Impact of Covid-19 in Congenital Heart Disease

NCT ID: NCT04336384

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-12-30

Brief Summary

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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

Detailed Description

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Conditions

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Congenital Heart Disease Covid-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pr. Jean-Benoît THAMBO, Bordeaux (président)

UNKNOWN

Sponsor Role collaborator

Dr. Céline GRUNENWALD GRONIER, Strasbourg

UNKNOWN

Sponsor Role collaborator

Dr. Sébastien HASCOET, Le Plessis-Robinson

UNKNOWN

Sponsor Role collaborator

Dr. Adeline BASQUIN, Rennes

UNKNOWN

Sponsor Role collaborator

Dr. Nicolas COMBES, Toulouse

UNKNOWN

Sponsor Role collaborator

Dr. Xavier IRIART, Bordeaux

UNKNOWN

Sponsor Role collaborator

Dr. Daniela LAUX, Paris

UNKNOWN

Sponsor Role collaborator

Dr. Magalie LADOUCEUR, Paris

UNKNOWN

Sponsor Role collaborator

Pr. BERTRAND LEOBON, Toulouse

UNKNOWN

Sponsor Role collaborator

Pr. Caroline OVAERT, Marseille

UNKNOWN

Sponsor Role collaborator

Dr. Karine WARIN-FRESSE, Nantes

UNKNOWN

Sponsor Role collaborator

Alexis BLANC, Montpellier

UNKNOWN

Sponsor Role collaborator

Pr. Roland HENAINE, Lyon

UNKNOWN

Sponsor Role collaborator

Hamouda ABASSI, Montpellier

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal AMEDRO, MD-PhD

Role: STUDY_DIRECTOR

UH MONTPELLIER

Locations

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Uh Montpellier

Montpellier, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 17210844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32091533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32171076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32167524 (View on PubMed)

Other Identifiers

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RECHMPL20_0155

Identifier Type: -

Identifier Source: org_study_id

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