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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02923440
Recruitment Status : Unknown
Verified September 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Not yet recruiting
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Congenital Heart Defects Biological: blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Congenital heart defects Biological: blood sample

Primary Outcome Measures :
  1. number of patient with Congenital Heart Defects [ Time Frame: 3years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Persons not beneficiaries of a social security scheme
  • Persons in health or social institution

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02923440

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Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT02923440    
Other Study ID Numbers: 2016-A00958-43
2016-13 ( Other Identifier: AP HM )
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities