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RecruitingNCT02432079Updated Jun 22, 2026

Molecular Genetics of Heterotaxy and Related Congenital Heart Defects

An observational study in Heterotaxy Syndrome and Congenital Heart Defects, sponsored by Indiana University. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Indiana University · Observational

Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
2,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heterotaxy Syndrome
  • Congenital Heart Defects

Keywords

  • Abnormalities, Multiple
  • Asplenia
  • Bilary Atresia
  • Birth Defect
  • Cardiovascular Abnormalities
  • Cardiovascular Diseases
  • Congenital Abnormalities
  • Congenital Heart Disease
  • Dextrocardia Syndrome
  • Disturbed Internal Organ Positioning
  • Genetics
  • Genetic Testing
  • Heart Defects, Congenital
  • Heart Diseases
  • Heterotaxy syndrome
  • Intestinal malrotation
  • Laterality
  • Left Atrial Isomerism
  • Pediatrics
  • Polysplenia
  • Right Atrial Isomerism
  • Splenic Diseases
  • Cilia
  • Situs inversus
  • Dextrocardia
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

children affected with heterotaxy syndrome and/or congenital heart defects and their relatives

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Subjects without heterotaxy and related congenital heart defects
  • Family members of subjects without heterotaxy and related congenital heart defects
04

Study design

Observational model
Family-based
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Heterotaxy and congenital heart defects

    Patients and family members with heterotaxy and related congenital heart defects

05

What researchers measure

Primary outcomes

  1. Clarify Molecular Genetics of Heterotaxy and Related Congenital Heart Defects

    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.

    Time frame: 8 years

06

Study locations

1 of 1 sites recruiting
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
    • Lindsey R Helvaty, BA, BS · Contact · lhelvaty@iu.edu · 317-278-3020
    • Stephanie M Ware, MD, PhD · Contact · stware@iu.edu · 317-278-2807
    Recruiting
07

Registry details

Key details

Study ID
NCT02432079
Lead sponsor
Indiana University
Responsible party
Stephanie Ware (Professor of Pediatrics and Medical and Molecular Genetics, Indiana University) — Principal investigator
First posted
May 1, 2015
Start date
Jul 2009
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jun 22, 2026

Study contacts

Sarah K. Murphy, MPH
Contact
bankssk@iu.edu
317-278-3026
Stephanie M. Ware, MD, PhD
Contact
stware@iu.edu
317-278-2807
Stephanie M. Ware, MD, PhD
principal investigator · Indiana University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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