Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssistance Publique Hopitaux De Marseille

About this trial

Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000 newborns per year. The south-east region of France is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. The majority of congenital heart diseases remain unexplained. Genetic causes are indisputable but remain poorly understood. Genetic research needs the availability of a large-scale DNA collection, guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a bank is currently unavailable in south-east France. To transport biological specimens from Marseille to Paris would be very expensive. In addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU research unit. For those reasons it is highly preferable to elaborate such a database and DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this DNA-bank

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Echocardiographic diagnosis of congenital heart defect falling within the classification Houyel and Bonnet

Necessity of making a blood test regardless of study

Medical care in the AP-HM Timone Hospital children, medical-surgical unit of pediatric and congenital cardiology, Marseille - These Parent Child

Disqualifiers

Pregnant women

Patients or parent / legal guardian (if minor) in physical or mental incapacity to understand or sign the consent

People in Emergencies

Persons deprived of freedom

Trial design

Design model

Single group

Treatments tested in this trial

  • blood sample

    Biological/Vaccine

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Congenital heart defectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

number of patient with Congenital Heart Defects

Time frame
3years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.