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NCT01196182 Clinical Trial

Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)

Congenital Heart Defects Clinical Trial

— CHD GENES  

Official title:
Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01196182
Other study ID # 701
Secondary ID 5U01HL098188-03U
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2010
Est. completion date December 2025

Study information
Verified date August 2023
Source Children's Hospital Medical Center, Cincinnati
Contact Eileen King, PhD
Email B2BProgram@cchmc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 99 Years
Eligibility Inclusion Criteria: • Signed consent form Exclusion Criteria: - Isolated patent foramen ovale - Isolated prematurity-associated patent ductus arteriosus

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom University College London London
United States Brigham & Women's Hospital Boston Massachusetts
United States Children's Hospital Boston Boston Massachusetts
United States Children's Hospital Los Angeles Los Angeles California
United States Yale University New Haven Connecticut
United States Cohen Children's Medical Center New York New Hyde Park New York
United States Columbia University Medical Center New York New York
United States Mount Sinai School of Medicine New York New York
United States Stanford University Palo Alto California
United States Children's Hospital Philadelphia Philadelphia Pennsylvania
United States University of Rochester Rochester New York
United States University of Utah Salt Lake City Utah
United States University of California, San Francisco San Francisco California

Sponsors (2)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  United Kingdom, 

See also
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