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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00860327
Recruitment Status : Terminated
First Posted : March 12, 2009
Last Update Posted : August 22, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mary Wagner, Emory University

Brief Summary:
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 or disease
Hypoplastic Left Heart Syndrome Tetralogy of Fallot

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
Actual Enrollment : 375 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Excitation-contraction Coupling in Human Ventricle Development
Study Start Date : December 2007
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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

Primary Outcome Measures :
  1. 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children undergoing surgery for repair of congenital heart defects.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00860327

United States, Georgia
Emory University, Department of Pediatrics
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Mary B. Wagner, PhD Emory University

Publications of Results:
Responsible Party: Mary Wagner, Assistant Professor, Emory University Identifier: NCT00860327     History of Changes
Other Study ID Numbers: IRB00007244
R01HL088488 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016

Keywords provided by Mary Wagner, 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