Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development
4 other identifiers
observational
600
1 country
1
Brief Summary
The study team will use small pieces of human hearts which are removed as part of a required surgical procedure to study different objectives. One of the objective is how calcium ions pass through the membrane of heart cells in order to tell the heart cell how much force to contract with when the heart beats. Investigators will also study the proteins and RNA of these pieces to determine how the newborn heart cells control their force of contraction differently from adult heart cells. Investigators hypothesize that infant hearts have different regulation of calcium entry than adult hearts. The study team also wants to study combinations of 3D cardiac spheres with multiple environmental cues that can improve functional and metabolic maturation of Human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) and generate a more clinically relevant cell model.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 24, 2005
CompletedFirst Posted
Study publicly available on registry
October 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 6, 2026
May 1, 2026
22.7 years
October 24, 2005
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Calcium Current Measures
Calcium currents including transients and modulation of calcium handling by activation of different pathways in isolated cells from waste tissue obtained at the time of surgical repair for Congenital Heart Disease will be measured for the duration of the study.
Duration of Study (Up to 13 Years)
Change in structural, functional and metabolic maturation of Human pluripotent stem cell derived Cardiomyocytes (hPSC-CMs)
Change in structural, functional and metabolic maturation of Human pluripotent stem cell derived Cardiomyocytes (hPSC-CMs) is achieved using combinations of 3D cardiac spheres with multiple environmental cues to improve mitochondrial fatty acid oxidation (FAO or beta-oxidation) pathway will promote functional and metabolic maturation of hPSC-CMs and generate a more clinically relevant model. The outcome will be measured whether the cells achieved maturation (structural, functional and metabolic maturation) or not after using combinations of 3D cardiac spheres with multiple environmental cues.
Duration of Study (Up to 3 Years)
Study Arms (1)
Cardiac Tissue
Cardiac tissue and cells will be obtained from participants undergoing cardiac surgical repair
Eligibility Criteria
Children undergoing surgery for repair of congenital heart disease
You may qualify if:
- Patients undergoing cardiopulmonary bypass surgery
- Patients undergoing surgery for repair of congenital heart disease such as ventricular septal defect or defective mitral or aortic valves.
You may not qualify if:
- Prior cardiac surgery
- History of atrial fibrillation or other atrial arrhythmias prior to operation
- History of heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
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: 19127223RESULT
Biospecimen
tissue obtained from surgical waste tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael E Davis, PhD
Emory University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 24, 2005
First Posted
October 25, 2005
Study Start
April 1, 2005
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 6, 2026
Record last verified: 2026-05