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ACTIVE NOT RECRUITING

Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)

NCT01196182 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Study Locations (15)

New York

  • Cohen Children's Medical Center New York — New Hyde Park
  • Mount Sinai School of Medicine — New York
  • Columbia University Medical Center — New York
  • University of Rochester — Rochester

California

  • Children's Hospital Los Angeles — Los Angeles
  • Stanford University — Palo Alto
  • University of California, San Francisco — San Francisco

Massachusetts

  • Brigham & Women's Hospital — Boston
  • Children's Hospital Boston — Boston

Connecticut

  • Yale University — New Haven

Georgia

  • Children's Healthcare of Atlanta — Atlanta

Michigan

  • University of Michigan Health — Ann Arbor

Pennsylvania

  • Children's Hospital Philadelphia — Philadelphia

Utah

  • University of Utah — Salt Lake City

Trial Details

FieldValue
Enrollment Target 32,000 participants
Start Date 2010-11-15
Est. Completion 2032-12

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01196182

The ClinicalTrials.gov registry entry for NCT01196182 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 715 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Congenital Heart Defects appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01196182 reports 15 study locations spanning 9 distinct geographic areas — top geographies include New York, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01196182 about?

NCT01196182 is a clinical study titled "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 e...

What is the current status of trial NCT01196182?

This trial is currently active not recruiting. The enrollment target is 32,000 participants. The study started on 2010-11-15. Estimated completion is 2032-12.

What conditions does trial NCT01196182 study?

This clinical trial studies the following conditions: Congenital Heart Defects. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT01196182?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 715 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01196182 being conducted?

This trial has 15 study locations across California, Connecticut, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial