Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 20
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Prior cardiac surgery
History of atrial fibrillation or other atrial arrhythmias prior to operation
History of heart failure
Trial population
Children undergoing surgery for repair of congenital heart disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 1 trial groupGroup A: Cardiac Tissue
Trial outcomes
Primary outcomes
1
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.
Time frame
Duration of Study (Up to 13 Years)2
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.
Time frame
Duration of Study (Up to 3 Years)Sponsors and contacts
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Emory University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov