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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)

Primary Purpose

Congenital Heart Defects

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

blood sample

About this trial

This is an interventional diagnostic trial for Congenital Heart Defects

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Congenital heart defects

Arm Description

Outcomes

Primary Outcome Measures

number of patient with Congenital Heart Defects

Secondary Outcome Measures

Full Information

NCT ID

NCT02923440

First Posted

September 30, 2016

Last Updated

March 9, 2023

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT02923440

Brief Title

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

Acronym

SEA-HD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 17, 2017 (Actual)

Primary Completion Date

January 2028 (Anticipated)

Study Completion Date

March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Heart Defects

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Congenital heart defects

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

blood sample

Primary Outcome Measure Information:

Title

number of patient with Congenital Heart Defects

Time Frame

3years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

CAROLINE OVAERT

caroline.ovaert@ap-hm.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

catherine GEINDRE

Organizational Affiliation

ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

Official's Role

Study Director

Facility Information:

Facility Name

Assistance Publique Hopitaux de Marseille

City

Marseille

ZIP/Postal Code

13354

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

caroline OVAERT

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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