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Clinical Trials/NCT02432079
NCT02432079
Recruiting
Not Applicable

Molecular Genetics of Heterotaxy and Related Congenital Heart Defects

Indiana University1 site in 1 country2,000 target enrollmentJuly 1, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heterotaxy Syndrome
Sponsor
Indiana University
Enrollment
2000
Locations
1
Primary Endpoint
Clarify Molecular Genetics of Heterotaxy and Related Congenital Heart Defects
Status
Recruiting
Last Updated
10 months ago

Overview

Brief Summary

The goal of this study is to obtain specimens and data from individuals and their families with heterotaxy and related congenital heart defects in order to clarify the molecular genetics of this disorder. The knowledge gained from the analysis of this information will provide the basis for future genetic counseling as well as contribute to knowledge about the biology of normal and abnormal development of left-right anatomic asymmetry.

Detailed Description

Heterotaxy syndrome is a rare birth defect that involves the heart and other organs. Many cases are genetic. Fundamental lack of information about the genetic basis of heterotaxy and related congenital heart defects in the vast majority of children has hindered management and therapy. The study outlined in this protocol is designed to obtain information about the causes of heterotaxy and related congenital heart defects. In this study, investigators will perform genetic analyses on patients with heterotaxy and related congenital heart defects, or individuals at risk for these abnormalities. The investigators will collect medical information related to symptoms and disease course. These results will provide important information on the causes, management, and prognosis of heterotaxy and related congenital heart defects.

Registry
clinicaltrials.gov
Start Date
July 1, 2009
End Date
December 1, 2030
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephanie Ware

Professor of Pediatrics and Medical and Molecular Genetics

Indiana University

Eligibility Criteria

Inclusion Criteria

  • Subjects with heterotaxy and related congenital heart defects
  • Family members of subjects with heterotaxy and related congenital heart defects

Exclusion Criteria

  • Subjects without heterotaxy and related congenital heart defects
  • Family members of subjects without heterotaxy and related congenital heart defects

Outcomes

Primary Outcomes

Clarify Molecular Genetics of Heterotaxy and Related Congenital Heart Defects

Time Frame: 8 years

These results will provide important information on the causes, management, and prognosis of heterotaxy and related congenital heart defects. This will provide the basis for future genetic testing and genetic counseling as well as contribute to knowledge about the biology of normal and abnormal development of left-right asymmetry.

Study Sites (1)

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