Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Congenital Heart Defects |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
• Signed consent form
Exclusion Criteria:
- Isolated patent foramen ovale
- Isolated prematurity-associated patent ductus arteriosus
Contacts and Locations| Contact: Kimberly J. Dandreo, MSc | (617) 972-3219 | kdandreo@neriscience.com |
| United States, California | |
| Children's Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Josephine Ellashek, RN 323-361-6355 jellashek@chla.usc.edu | |
| Contact: Richard W Kim, MD 323-361-4148 rikim@chla.usc.edu | |
| Principal Investigator: Richard W Kim, MD | |
| United States, Connecticut | |
| Yale University | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Nancy Cross 203-737-6835 nancy.cross@yale.edu | |
| Contact: Anita Farhi (800) 575-9253 anita.farhi@yale.edu | |
| Principal Investigator: Martina Brueckner, MD | |
| Principal Investigator: Richard P Lifton, MD, PHD | |
| United States, Massachusetts | |
| Children's Hospital Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Judith Geva, MSW 617-355-4979 judith.geva@cardio.chboston.org | |
| Contact: Jan Stryker, MS (857) 218-4628 Janice.Stryker@cardio.chboston.org | |
| Principal Investigator: Jane Newburger, MD, MPH | |
| Brigham & Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Barbara McDonough, RN 617-432-1006 mcdonough@genetics.med.harvard.edu | |
| Contact: Christine Seidman, MD cseidman@genetics.med.harvard.edu | |
| Principal Investigator: Christine Seidman, MD | |
| United States, New York | |
| Cohen Children's Medical Center New York | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Dorota Gruber, MS, GC 347-804-4996 DGruber1@nshs.edu | |
| Contact: Christine DeMers, RN (516) 562-1021 CDemers@nshs.edu | |
| Principal Investigator: Howard Seiden, MD | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Tejani Mendiz-Ramdeen 212-241-6012 Tejani.mendiz-ramdeen@mssm.edu | |
| Contact: Bruce D. Gelb, MD (212) 241-8662 bruce.gelb@mssm.edu | |
| Principal Investigator: Bruce Gelb, MD | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Danielle Awad, MPH 212-305-9391 da2377@columbia.edu | |
| Contact: Rosalind Korsin (212) 342-0524 rk271@columbia.edu | |
| Principal Investigator: Wendy K Chung, MD, PHD | |
| Principal Investigator: Dorothy Warburton, PHD | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Eileen Taillie, MGS 585-273-4168 Eileen_Taillie@URMC.Rochester.edu | |
| Contact: George A. Porter, MD, PhD (585) 276-4769 george_porter@urmc.rochester.edu | |
| Principal Investigator: George A Porter, MD, PHD | |
| United States, Pennsylvania | |
| Children's Hospital Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jennifer Garbarini, MS, CGC 215-590-1473 garbarini@email.chop.edu | |
| Contact: Stacy Woyciechowski, MS, CGC (267) 426-7484 woyciechowski@email.chop.edu | |
| Principal Investigator: Elizabeth Goldmuntz, MD | |
| United Kingdom | |
| University College London | Recruiting |
| London, United Kingdom, WC1N3JH | |
| Contact: Joanne Soper 44 (207) 405-9200 ext 2752 DavieJ2@gosh.nhs.uk | |
| Contact: John Deanfield, MD 44 (207) 405-9200 ext 5243 j.deanfield@ich.ucl.ac.uk | |
| Principal Investigator: John Deanfield, MD | |
| Principal Investigator: Alessandro Giardini, MD | |
| Principal Investigator: | Jane Newburger, 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 |
| Principal Investigator: | Dorothy Warburton, PhD | Columbia University Medical Center, New York NY |
| Principal Investigator: | Richard Lifton, MD, PhD | Yale University |
More Information
Additional Information:
No publications provided
| Responsible Party: | New England Research Institutes |
| ClinicalTrials.gov Identifier: | NCT01196182 History of Changes |
| Other Study ID Numbers: | 701, 5U01HL098188-03, U01HL098188, U01HL098147, U01HL098163, U01HL098153, U01HL098123, U01HL098162 |
| Study First Received: | September 3, 2010 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Heart Defects, Congenital Heart Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 21, 2013