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NCT04740177: EPIDEMIO-CHD

Epidemiology of Congenital Heart Disease in France

Completed Last updated 16 March 2021
What this trial tests

trial in Congenital Heart Disease in 450,000 participants. Completed in 30 December 2020.

Timeline
1 February 2020
Primary endpoint
1 December 2020
30 December 2020

Quick facts

Lead sponsorUniversity Hospital, Montpellier
StatusCompleted
Study typeOBSERVATIONAL
Enrollment450,000
Start date1 February 2020
Primary completion1 December 2020
Estimated completion30 December 2020
Sites1 location across France

Conditions studied

Sponsor

University Hospital, Montpellier

Who can join

Eligibility, any sex, with Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Congenital Heart Disease

Currently open trials in the same condition.

Other University Hospital, Montpellier trials

Trials by the same sponsor.

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Data sources for this page

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