Epidemiology of Congenital Heart Disease in France

NCT04740177 | Completed

• 1 other identifier: RECHMPL20_0119
• Study Type: observational
• Target: 450,000
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Since the 1980s, France has been a pioneer in neonatal CHD surgery (Pr. Fontan, Pr. Lecomte, Pr. Serraf, etc.), in prenatal diagnosis, and in interventional cardiac catheterization. Actually, first children operated for complex CHD have reached adulthood and a new epidemiology of CHD is emerging. Currently, one of the public health challenges is the need to maintain appropriate follow-up and to avoid disruption of care during the transition from adolescence to adulthood. Thus, the national health authorities (DGOS) recently certified a national network of expert centers for complex CHD (M3C). In addition, under the leadership of the French Society of Cardiology, the sub-specialty of Pediatric and Congenital Cardiology has been recognized. However, while North American and North European countries have published their updated data on the main indicators of CHD morbidity and mortality, no study has reported epidemiology of CHD in France. Currently, available data are approximate, estimating that 200,000 children and 250,000 adults would be living in France with a CHD. Nevertheless, no information is available on hospitalizations, type of CHD, their follow-up, possible disruption in care, and morbidity and mortality in patients with CHD in France. This epidemiological study will use the national health insurance hospital database to answer these questions.

Conditions

Congenital Heart Disease

Keywords

Congenital heart disease; Paediatric cardiology; Epidemiology; M3C network

Outcome Measures

Primary Outcomes (1)

• Rate of patients with CHD hospitalized in France

  Rate of patients with CHD hospitalized in France

  10 years

Secondary Outcomes (5)

• Rate of mortality in patients with CHD

  10 years

• Rate of cardiac surgery-related mortality in patients with CHD

  10 years

• Rate of cardiac catheter-related mortality in patients with CHD

  10 years

• Rate of CHD patient's loss to follow-up within and outside the national M3C network

  10 years

• Rate of CHD prenatal diagnosis

  10 years

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

Patient with congenital heart disease (CHD)

You may qualify if:

• \- Patient (of any age) with a CHD as defined by the international ACC-CHD classification and listed in the ICD10 classification, hospitalized from 01/01/2010 to 12/31/2019 in a French tertiary care hospital from the M3C network.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• National Reference Center for Complex Congenital Heart Disease, Marie-Lannelongue Medical and Surgical Center, Le Plessis Robinson: collaborator
• University Hospital, Bordeaux: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pascal AMEDRO, MD-PhD

  UH MONTPELLIER

  STUDY DIRECTOR

• Sarah Cohen

  • Centre Médico-Chirurgical Marie-Lannelongue, Le Plessis Robinson

  PRINCIPAL INVESTIGATOR

• Jean-Benoit Thambo

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: February 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-01

Locations

FR (1)