Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) (CHD GENES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01196182
Recruitment Status : Recruiting
First Posted : September 8, 2010
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date September 3, 2010
First Posted Date September 8, 2010
Last Update Posted Date January 25, 2019
Study Start Date November 2010
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01196182 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)
Official Title Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood; possibly saliva and tissue.
Sampling Method Non-Probability Sample
Study Population

While all patients with pediatric cardiovascular disease and adults with congenital heart disease are of interest, the study will initially focus on four CHD anatomic classifications:

  • Atrial septal defects
  • Conotruncal abnormalities
  • Left-sided obstructive lesions
  • Heterotaxy

Whenever possible, the study will recruit "trios" of participants--children, mothers and fathers-- as well as extended family members when appropriate and feasible.

Condition Congenital Heart Defects
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September¬†3,¬†2010)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

• Signed consent form

Exclusion Criteria:

  • Isolated patent foramen ovale
  • Isolated prematurity-associated patent ductus arteriosus
Sex/Gender
Sexes Eligible for Study: All
Ages up to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Eileen King, PhD 513-803-1819 Eileen.King@cchmc.org
Contact: Marianne Hird 513-517-0279 marianne.hird@cchmc.org
Listed Location Countries United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01196182
Other Study ID Numbers 701
5U01HL098188-03 ( U.S. NIH Grant/Contract )
U01HL098188 ( U.S. NIH Grant/Contract )
U01HL098147 ( U.S. NIH Grant/Contract )
U01HL098163 ( U.S. NIH Grant/Contract )
U01HL098153 ( U.S. NIH Grant/Contract )
U01HL098123 ( U.S. NIH Grant/Contract )
U01HL098162 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Amy Roberts, MD Childrens Hospital Boston
Principal Investigator: Christine Seidman, MD Harvard Medical School, Boston MA
Principal Investigator: Bruce Gelb, MD Mt Sinai School of Medicine, New York NY
Principal Investigator: Martina Brueckner, MD Yale University
Principal Investigator: Elizabeth Goldmuntz, MD Childrens Hospital of Philadelphia PA
Principal Investigator: Wendy Chung, MD, PhD Columbia University Medical Center, New York NY
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date January 2019