Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)

Recruiting

• Conditions: Congenital Heart Defects

• Registration Number: NCT01196182
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-08
• Study Start: 2010-11-15
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-17
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32000

Inclusion Criteria

• Signed consent form

Exclusion Criteria

• Isolated patent foramen ovale
• Isolated prematurity-associated patent ductus arteriosus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (15)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

University of Michigan Health; 🇺🇸 Ann Arbor, Michigan, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States

Cohen Children's Medical Center New York; 🇺🇸 New Hyde Park, New York, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

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