Epidemiology of Congenital Heart Disease in France

Congenital Heart Disease Clinical Trial

— EPIDEMIO-CHD  

Official title:

Epidemiology of Congenital Heart Disease in France : EPIDEMIO-CHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740177
• Other study ID #: RECHMPL20_0119
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Retrospective epidemiological study based on the national health insurance hospital database from 2010 to 2020 (10 years): Main objective: • To assess the prevalence of patients with CHD hospitalized in France over 10 years. Secondary objectives: asess over the same period: - Overall mortality rate according to the CHD classification and the geographic area - Overall morbidity rate, according to the CHD classification and the geographic area - Overall cardiac surgery-related mortality rate (cardiac surgery and other surgery), according to the CHD classification (adjusted for the severity of the CHD and the surgical procedure) and to geographic area - Overall cardiac catheter-related mortality rate, according to the CHD classification (adjusted for the severity of the CHD and the catheterization procedure) and to geographic area - CHD follow-up within and outside the national M3C network - Periods of loss of cardiological follow-up (within or outside the M3C network, in hospital or in town) - Obstetrical data for women (parity, pregnancy) - The existence of a prenatal diagnosis (yes / no and the term of pregnancy at the time of diagnosis of CHD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450000
• 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 (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.

Exclusion criteria:

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	National Reference Center for Complex Congenital Heart Disease, Marie-Lannelongue Medical and Surgical Center, Le Plessis Robinson, National Reference Center for Complex Congenital Heart Disease, University Hospital of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with CHD hospitalized in France	Rate of patients with CHD hospitalized in France	10 years
Secondary	Rate of mortality in patients with CHD	Rate of mortality in patients with CHD	10 years
Secondary	Rate of cardiac surgery-related mortality in patients with CHD	Rate of cardiac surgery-related mortality in patients with CHD	10 years
Secondary	Rate of cardiac catheter-related mortality in patients with CHD	Rate of cardiac catheter-related mortality in patients with CHD	10 years
Secondary	Rate of CHD patient's loss to follow-up within and outside the national M3C network	Rate of CHD patient's loss to follow-up within and outside the national M3C network	10 years
Secondary	Rate of CHD prenatal diagnosis	Rate of CHD prenatal diagnosis	10 years