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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mary Wagner, Emory University
ClinicalTrials.gov Identifier:
NCT00860327
First received: March 10, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition
Hypoplastic Left Heart Syndrome
Tetralogy of Fallot

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Excitation-contraction Coupling in Human Ventricle Development

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Calcium handling assay [ Time Frame: At time of aquisition ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Ventricular tissue, that would have been discarded, and was removed during surgery as part of the necessary repair for congenital heart defects


Estimated Enrollment: 300
Study Start Date: December 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children undergoing surgery for repair of congenital heart defects.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860327

Contacts
Contact: Mary B. Wagner, PhD 404-727-1336 mary.wagner@emory.edu
Contact: Janet Fernandez, RN 404-785-1731 janet.fernandez@choa.org

Locations
United States, Georgia
Emory University, Department of Pediatrics Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Mary B. Wagner, PhD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Mary B. Wagner, PhD Emory University
  More Information

Publications:
Responsible Party: Mary Wagner, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00860327     History of Changes
Other Study ID Numbers: IRB00007244, R01HL088488, R01 HL088488
Study First Received: March 10, 2009
Last Updated: April 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Emory University:
Pediatric Heart Disease
Congenital Heart Disease
Congenital Heart Defects
Developmental Biology
Contractile Function

Additional relevant MeSH terms:
Heart Defects, Congenital
Hypoplastic Left Heart Syndrome
Tetralogy of Fallot
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 22, 2014