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

NCT00860327 | Terminated

• 2 other identifiers: IRB00007244R01HL088488
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoplastic Left Heart Syndrome; Tetralogy of Fallot

Keywords

Pediatric Heart Disease; Congenital Heart Disease; Congenital Heart Defects; Developmental Biology; Contractile Function

Outcome Measures

Primary Outcomes (1)

• Calcium handling assay

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing surgery for repair of congenital heart defects.

You may qualify if:

• 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

You may not qualify if:

• \- Children \> 12 months of age

Sponsors & Collaborators

• Emory University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Emory University, Department of Pediatrics

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Wiegerinck RF, Cojoc A, Zeidenweber CM, Ding G, Shen M, Joyner RW, Fernandez JD, Kanter KR, Kirshbom PM, Kogon BE, Wagner MB. Force frequency relationship of the human ventricle increases during early postnatal development. Pediatr Res. 2009 Apr;65(4):414-9. doi: 10.1203/PDR.0b013e318199093c.

  PMID: 19127223 RESULT

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

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome; Tetralogy of Fallot; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mary B. Wagner, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 12, 2009
• Study Start: December 1, 2007
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 22, 2016

Record last verified: 2016-08

Locations

US (1)