Examining Developmental Changes in Heart Contractions of Children With Congenital Heart Defects

August 19, 2016 updated by: Mary Wagner, Emory University

Excitation-contraction Coupling in Human Ventricle Development

Children who are born with heart defects undergo surgery when they are infants to correct the defects. However, many treatments that are used in pediatric heart patients were originally developed for adults and may not be the best option for children. This study will analyze tissue samples from newborns and infants undergoing surgery for heart defects to learn more about how a child's heart develops during the first year of life. This information may help to identify possible treatments geared specifically for the pediatric heart patient.

Study Overview

Status

Terminated

Conditions

Detailed Description

Congenital heart defects are abnormalities or problems with the structure of the heart that are present at birth. Examples of congenital heart defects include hypoplastic left heart syndrome, which is a condition that occurs when the left side of the heart does not develop completely, and tetralogy of Fallot, which is a condition that involves four specific types of structural defects within the heart. Many advances have been made in recent years in the field of pediatric heart surgery, and children who are born with congenital heart defects are now able to undergo heart surgery as infants to repair the defects. However, very little is known about the differences between how an infant's heart functions and how an adult's heart functions. Thus, most of the therapies that are used to treat children with heart defects were originally developed for adults and may not be the best option for infants and young children. The purpose of this study is to gain a better understanding of how the heart changes during a child's first year of life, from being a newborn less than 1 week old to being an infant 3 to 12 months old.

During surgical repair of congenital heart defects, tissue from the ventricular structures of the heart is sometimes removed as part of the surgery. In this study, researchers will examine ventricular tissue removed during the surgical procedures of newborns with hypoplastic left heart syndrome and infants with tetralogy of Fallot. Study researchers will compare the newborn and infant tissue samples in terms of their differences in excitation-contraction coupling, also referred to as contraction response. Excitation-contraction coupling in the heart is the process wherein electrical activity of the heart is translated into contraction of the heart muscle, which then results in pumping of the blood out to the body. Study researchers will also examine how calcium, which is required for heart contraction, flows in and out of heart cells to determine whether the process differs among newborns and infants. Acquiring data on both excitation-contraction coupling and the role of calcium is important because increasing the strength of heart contractions is a key component of treatment options for children with congenital heart defects.

This study has been granted a waiver of consent as de-identified tissue will be collected from waste samples. The number of participants represents the number of samples collected.

Study Type

Observational

Enrollment (Actual)

375

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University, Department of Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children undergoing surgery for repair of congenital heart defects.

Description

Inclusion Criteria:

  • Newborns less than 1 week of age with hypoplastic left heart syndrome
  • Infants between 3 to 12 months of age with tetralogy of Fallot
  • Requires removal of ventricular tissue during surgery as part of the repair for a congenital heart defect

Exclusion Criteria

- Children > 12 months of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Newborns
Newborns with hypoplastic left heart syndrome who are receiving a right ventricle to pulmonary artery shunt as first stage palliation.
Infants
Infants who are undergoing complete repair for tetralogy of Fallot or similar pathology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcium handling assay
Time Frame: At time of aquisition
Calcium handling will be assayed in tissue or cells by patch clamp, imaging or protein level measurement and will be done at the time the tissue is obtained.
At time of aquisition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Mary B. Wagner, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00007244
  • R01HL088488 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tetralogy of Fallot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe