Clinical Trials Logo
  1. Home
  2. Congenital Heart Defects
  3. NCT02432079
  4. Details
NCT02432079 Clinical Trial

Molecular Genetics of Heterotaxy and Related Congenital Heart Defects

Congenital Heart Defects Clinical Trial

Official title:
Molecular Genetics of Heterotaxy and Related Congenital Heart Defects

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02432079
Other study ID # 1403871897
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2009
Est. completion date December 2030

Study information
Verified date February 2024
Source Indiana University
Contact Lindsey R. Helvaty, BA, BS
Phone 317-278-3020
Email lhelvaty@iu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 2030
Est. primary completion date December 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Indiana University School of Medicine Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 8 years
See also
  Status Clinical Trial Phase
Completed NCT01671566 - Interval Training in Adults With Congenital Heart Disease a Randomized Trial N/A
Recruiting NCT01421030 - Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques Phase 0
Withdrawn NCT00981591 - Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients Phase 1/Phase 2
Completed NCT01567579 - An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
Terminated NCT00208676 - Using Tissue Doppler/Synchronization to Determine Heart Function in Children With Congenital Heart Disease N/A
Completed NCT01941576 - Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot N/A
Completed NCT01475357 - Intestinal Function in Neonates With Complex Congenital Heart Disease N/A
Active, not recruiting NCT01227096 - Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery N/A
Completed NCT01201486 - Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester N/A
Completed NCT00397514 - Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery N/A
Completed NCT02232399 - Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease? Phase 2
Completed NCT05191654 - Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD
Recruiting NCT06267859 - Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children Early Phase 1
Completed NCT02320669 - Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass Phase 3
Completed NCT01489475 - Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass N/A
Withdrawn NCT00579358 - Molecular Basis of Congenital Heart Defects
Recruiting NCT01196182 - Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)
Recruiting NCT04382573 - Better Delineation of CDK13 Related Phenotype and Epigenetic Signature.
Recruiting NCT03822442 - MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients
Completed NCT00450684 - Cardiac Resynchronization Therapy in Congenital Heart Defects Phase 2/Phase 3