Congenital Heart Defects Clinical Trial
— SEA-HDOfficial title:
Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways
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
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | March 2028 |
| Est. primary completion date | January 2028 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of patient with Congenital Heart Defects | 3years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01671566 -
Interval Training in Adults With Congenital Heart Disease a Randomized Trial
|
N/A | |
| Recruiting |
NCT01421030 -
Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques
|
Phase 0 | |
| Completed |
NCT01567579 -
An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
|
||
| Withdrawn |
NCT00981591 -
Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients
|
Phase 1/Phase 2 | |
| Terminated |
NCT00208676 -
Using Tissue Doppler/Synchronization to Determine Heart Function in Children With Congenital Heart Disease
|
N/A | |
| Completed |
NCT01941576 -
Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
|
N/A | |
| Completed |
NCT01475357 -
Intestinal Function in Neonates With Complex Congenital Heart Disease
|
N/A | |
| Active, not recruiting |
NCT01227096 -
Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery
|
N/A | |
| Completed |
NCT01201486 -
Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester
|
N/A | |
| Completed |
NCT00397514 -
Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
|
N/A | |
| Completed |
NCT02232399 -
Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?
|
Phase 2 | |
| Completed |
NCT05191654 -
Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD
|
||
| Recruiting |
NCT06267859 -
Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children
|
Early Phase 1 | |
| Completed |
NCT02320669 -
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
|
Phase 3 | |
| Completed |
NCT01489475 -
Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass
|
N/A | |
| Withdrawn |
NCT00579358 -
Molecular Basis of Congenital Heart Defects
|
||
| Recruiting |
NCT01196182 -
Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)
|
||
| Recruiting |
NCT03822442 -
MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients
|
||
| Recruiting |
NCT04382573 -
Better Delineation of CDK13 Related Phenotype and Epigenetic Signature.
|
||
| Completed |
NCT00450684 -
Cardiac Resynchronization Therapy in Congenital Heart Defects
|
Phase 2/Phase 3 |