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NCT Number: NCT04740177

Epidemiology of Congenital Heart Disease in France

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Rate of patients with CHD hospitalized in France

    Time frame: 10 years

    Rate of patients with CHD hospitalized in France

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

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

Registry information

Official study title

Epidemiology of Congenital Heart Disease in France : EPIDEMIO-CHD

Acronym: EPIDEMIO-CHD

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2021
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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