Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)

NCT ID: NCT01196182

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

32000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-15

Study Completion Date

2032-12-31

Brief Summary

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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

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Conditions

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Congenital Heart Defects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

• Signed consent form

Exclusion Criteria

* Isolated patent foramen ovale
* Isolated prematurity-associated patent ductus arteriosus
Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Roberts, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Hospital Boston

Christine Seidman, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School, Boston MA

Bruce Gelb, MD

Role: PRINCIPAL_INVESTIGATOR

Mt Sinai School of Medicine, New York NY

Martina Brueckner, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Martin Tristani-Firouzi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Yufeng Shen, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University Medical Center, New York NY

Shuo Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

University of Michigan Health

Ann Arbor, Michigan, United States

Site Status

Cohen Children's Medical Center New York

New Hyde Park, New York, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Children's Hospital Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

University College London

London, , United Kingdom

Site Status

Countries

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United States United Kingdom

References

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Jang MY, Patel PN, Pereira AC, Willcox JAL, Haghighi A, Tai AC, Ito K, Morton SU, Gorham JM, McKean DM, DePalma SR, Bernstein D, Brueckner M, Chung WK, Giardini A, Goldmuntz E, Kaltman JR, Kim R, Newburger JW, Shen Y, Srivastava D, Tristani-Firouzi M, Gelb BD, Porter GA Jr, Seidman CE, Seidman JG. Contribution of Previously Unrecognized RNA Splice-Altering Variants to Congenital Heart Disease. Circ Genom Precis Med. 2023 Jun;16(3):224-231. doi: 10.1161/CIRCGEN.122.003924. Epub 2023 May 11.

Reference Type DERIVED
PMID: 37165897 (View on PubMed)

Morton SU, Pereira AC, Quiat D, Richter F, Kitaygorodsky A, Hagen J, Bernstein D, Brueckner M, Goldmuntz E, Kim RW, Lifton RP, Porter GA Jr, Tristani-Firouzi M, Chung WK, Roberts A, Gelb BD, Shen Y, Newburger JW, Seidman JG, Seidman CE. Genome-Wide De Novo Variants in Congenital Heart Disease Are Not Associated With Maternal Diabetes or Obesity. Circ Genom Precis Med. 2022 Apr;15(2):e003500. doi: 10.1161/CIRCGEN.121.003500. Epub 2022 Feb 7.

Reference Type DERIVED
PMID: 35130025 (View on PubMed)

Oluwafemi OO, Musfee FI, Mitchell LE, Goldmuntz E, Xie HM, Hakonarson H, Morrow BE, Guo T, Taylor DM, McDonald-McGinn DM, Emanuel BS, Agopian AJ. Genome-Wide Association Studies of Conotruncal Heart Defects with Normally Related Great Vessels in the United States. Genes (Basel). 2021 Jul 1;12(7):1030. doi: 10.3390/genes12071030.

Reference Type DERIVED
PMID: 34356046 (View on PubMed)

Lahrouchi N, Postma AV, Salazar CM, De Laughter DM, Tjong F, Piherova L, Bowling FZ, Zimmerman D, Lodder EM, Ta-Shma A, Perles Z, Beekman L, Ilgun A, Gunst Q, Hababa M, Skoric-Milosavljevic D, Stranecky V, Tomek V, de Knijff P, de Leeuw R, Robinson JY, Burn SC, Mustafa H, Ambrose M, Moss T, Jacober J, Niyazov DM, Wolf B, Kim KH, Cherny S, Rousounides A, Aristidou-Kallika A, Tanteles G, Ange-Line B, Denomme-Pichon AS, Francannet C, Ortiz D, Haak MC, Ten Harkel AD, Manten GT, Dutman AC, Bouman K, Magliozzi M, Radio FC, Santen GW, Herkert JC, Brown HA, Elpeleg O, van den Hoff MJ, Mulder B, Airola MV, Kmoch S, Barnett JV, Clur SA, Frohman MA, Bezzina CR. Biallelic loss-of-function variants in PLD1 cause congenital right-sided cardiac valve defects and neonatal cardiomyopathy. J Clin Invest. 2021 Mar 1;131(5):e142148. doi: 10.1172/JCI142148.

Reference Type DERIVED
PMID: 33645542 (View on PubMed)

Sharma A, Wasson LK, Willcox JA, Morton SU, Gorham JM, DeLaughter DM, Neyazi M, Schmid M, Agarwal R, Jang MY, Toepfer CN, Ward T, Kim Y, Pereira AC, DePalma SR, Tai A, Kim S, Conner D, Bernstein D, Gelb BD, Chung WK, Goldmuntz E, Porter G, Tristani-Firouzi M, Srivastava D, Seidman JG, Seidman CE; Pediatric Cardiac Genomics Consortium. GATA6 mutations in hiPSCs inform mechanisms for maldevelopment of the heart, pancreas, and diaphragm. Elife. 2020 Oct 15;9:e53278. doi: 10.7554/eLife.53278.

Reference Type DERIVED
PMID: 33054971 (View on PubMed)

Boskovski MT, Homsy J, Nathan M, Sleeper LA, Morton S, Manheimer KB, Tai A, Gorham J, Lewis M, Swartz M, Alfieris GM, Bacha EA, Karimi M, Meyer D, Nguyen K, Bernstein D, Romano-Adesman A, Porter GA Jr, Goldmuntz E, Chung WK, Srivastava D, Kaltman JR, Tristani-Firouzi M, Lifton R, Roberts AE, Gaynor JW, Gelb BD, Kim R, Seidman JG, Brueckner M, Mayer JE Jr, Newburger JW, Seidman CE. De Novo Damaging Variants, Clinical Phenotypes, and Post-Operative Outcomes in Congenital Heart Disease. Circ Genom Precis Med. 2020 Aug;13(4):e002836. doi: 10.1161/CIRCGEN.119.002836. Epub 2020 Jun 30.

Reference Type DERIVED
PMID: 32812804 (View on PubMed)

Related Links

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http://www.benchtobassinet.org

Click here for more information about the entire Bench to Bassinet program.

Other Identifiers

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5U01HL098188-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01HL098188

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01HL098147

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01HL098163

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01HL098153

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01HL098123

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01HL098162

Identifier Type: NIH

Identifier Source: secondary_id

View Link

701

Identifier Type: -

Identifier Source: org_study_id

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