Epidemiology of Congenital Heart Disease in France (EPIDEMIO-CHD)

• ClinicalTrials.gov Identifier: NCT04740177
• Recruitment Status: Completed
• First Posted: February 5, 2021
• Last Update Posted: March 16, 2021
• Sponsor: University Hospital, Montpellier
• Collaborators: 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
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

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.

Condition or disease
Congenital Heart Disease

Detailed 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)

Study Design

• Study Type: Observational
• Actual Enrollment: 450000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Epidemiology of Congenital Heart Disease in France : EPIDEMIO-CHD
• Actual Study Start Date: February 1, 2020
• Actual Primary Completion Date: December 1, 2020
• Actual Study Completion Date: December 30, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Rate of patients with CHD hospitalized in France [ Time Frame: 10 years ]
   Rate of patients with CHD hospitalized in France

Secondary Outcome Measures :

1. Rate of mortality in patients with CHD [ Time Frame: 10 years ]
   Rate of mortality in patients with CHD
2. Rate of cardiac surgery-related mortality in patients with CHD [ Time Frame: 10 years ]
   Rate of cardiac surgery-related mortality in patients with CHD
3. Rate of cardiac catheter-related mortality in patients with CHD [ Time Frame: 10 years ]
   Rate of cardiac catheter-related mortality in patients with CHD
4. Rate of CHD patient's loss to follow-up within and outside the national M3C network [ Time Frame: 10 years ]
   Rate of CHD patient's loss to follow-up within and outside the national M3C network
5. Rate of CHD prenatal diagnosis [ Time Frame: 10 years ]
   Rate of CHD prenatal diagnosis

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patient with congenital heart disease (CHD)

Criteria

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).

Contacts and Locations

Locations

France

Uh Montpellier

Montpellier, France, 34295

Sponsors and Collaborators

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

Investigators

• Study Director: Pascal AMEDRO, MD-PhD; UH MONTPELLIER
• Principal Investigator: Sarah Cohen; • Centre Médico-Chirurgical Marie-Lannelongue, Le Plessis Robinson
• Principal Investigator: Jean-Benoit Thambo; University Hospital, Bordeaux

More Information

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT04740177
• Other Study ID Numbers: RECHMPL20_0119
• First Posted: February 5, 2021
• Last Update Posted: March 16, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: NC

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:

Congenital heart disease; Paediatric cardiology; Epidemiology; M3C network

Additional relevant MeSH terms:

Heart Diseases; Heart Defects, Congenital; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities