Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)
Congenital heart defects (CHD) are the most common major human birth malformation, affecting \~8 per 1,000 live births. CHD are associated with significant morbidity and mortality, and are second only to infectious diseases in contributing to the infant mortality rate. Current understanding of the etiology of pediatric cardiovascular disorders is limited. The Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) is a multi-center, prospective observational cohort study. Participants will be recruited from the Pediatric Cardiac Genomics Consortium's (PCGC) centers of the NHLBI-sponsored Bench to Bassinet (B2B) Program. Biological specimens will be obtained for genetic analyses, and phenotype data will be collected by interview and from medical records. State-of-the-art genomic technologies will be used to identify common genetic causes of CHD and genetic modifiers of clinical outcome. To accomplish this, the PCGC will develop and maintain a biorepository of specimens (DNA) and genetic data, along with detailed, phenotypic and clinical outcomes data in order to investigate relationships between genetic factors and phenotypic and clinical outcomes in congenital heart disease.
Conditions:
🦠 Congenital Heart Defects
🗓️ Study Start (Actual) 15 November 2010
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 10000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Los Angeles, California, United States
📍 Palo Alto, California, United States
📍 San Francisco, California, United States
📍 New Haven, Connecticut, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 New Hyde Park, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Rochester, New York, United States
📍 Philadelphia, Pennsylvania, United States
📍 Salt Lake City, Utah, United States
📍 London, United Kingdom

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • • Signed consent form

    Exclusion Criteria:

    • * Isolated patent foramen ovale
    • * Isolated prematurity-associated patent ductus arteriosus
Ages Eligible for Study: N/A to 99 Years (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 September 2010
  • First Submitted that Met QC Criteria 3 September 2010
  • First Posted 8 September 2010

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 August 2023
  • Last Update Posted 31 August 2023
  • Last Verified August 2023