Cardiovascular Disease Protection Tissue
Effects of ACE2/Ang-(1-7) on Cardiac Progenitor Cells From Heart Failure Patients and Explant Control
2 other identifiers
observational
8
1 country
1
Brief Summary
Recent evidence of a potential role for cardiac progenitor cells (CPCs) in cardiac repair and the discovery of a vasoprotective axis of the renin-angiotensin system (RAS) offer such breakthroughs. Investigators have observed that an imbalance in the vasoprotective axis {angiotensin converting enzyme 2 (ACE2)/angiotensin-(1-7) \[Ang-(1-7)\]/Mas receptor} and the vasodeleterious axis \[angiotensin converting enzyme (ACE)/angiotensin II (AngII)/AngII type 1 receptor (AT1R)\] of the RAS within the CPCs affects their functionality and regenerative potential. Investigators believe that restoring the balance between these two axes of the RAS is essential to improve CPC function and enhance their reparative capabilities. These observations have led to the hypothesis that genetic modification of CPCs by overexpression of ACE2/Ang-(1-7) will enhance their reparative function and improve their potential to attenuate myocardial ischemia-induced cardiac damage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2013
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
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 22, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2018
CompletedNovember 27, 2018
November 1, 2018
5.3 years
January 22, 2015
November 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Imbalance of vasoprotective and vasodeleterious axes of the renin angiotensin system (RAS) is associated with dysfunction of CPC isolated from diseased tissue
CPCs will be isolated from the collected heart tissue. Function assay such as proliferation, migration, reactive oxygen species (ROS) level will be analyzed. Renin-angiotensin system (RAS) genes and inflammatory cytokines will be quantifies using polymerase chain reaction (PCR) and protein assay to investigate if the cell dysfunction is associated with the imbalance of vasoprotective and vasodeleterious axes of the RAS.
two years
Secondary Outcomes (1)
Screening for biomarkers related to clinic outcome in the blood
two years
Study Arms (4)
Heart failure or coronary disease
This group will have small samples collected from the apex core (that would be routinely discarded at the time of the implantation procedure) by undergoing a left ventricular assist device implantation. In addition, a blood sample will be collected.
Heart transplant patients
This group will have multiple samples collected including, excess myocardial biopsy samples that will not be utilized by pathology. In addition, a blood sample will be collected.
Orthotopic Heart Transplant Patients
This group will have myocardial tissue samples collected from the diseased heart. In addition, a blood sample will be taken.
Heart Surgery Patients
This groups will have samples collected from the left atrial appendages that are routinely removed to prevent thrombosis during atrial fibrillation surgery and a piece of the right atria will be cut in order to implant the cannula. In addition, a blood sample will be taken.
Interventions
Small samples collected from the apex core in the heart. In addition, blood samples will be taken.
Heart samples collected including, excess myocardial biopsy samples. In addition, blood samples will be taken.
Myocardial tissue samples collected from the diseased heart. In addition, blood samples will be taken.
Heart samples will be collected from the left atrial appendages. In addition, blood samples will be taken.
All subjects will have 20 ml of blood drawn for further analysis.
Eligibility Criteria
Patients undergoing orthotopic heart transplant, left ventricular assist device implantation, right heart biopsy, and any other heart surgery (atrial fibrillation and right atria cannulation).
You may qualify if:
- heart transplant surgery
- left ventricular assist device implantation
- heart surgery required for atrial fibrillation and right atria cannulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Institutes of Health (NIH)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Yanfei Qi
Gainesville, Florida, 32610, United States
Biospecimen
Blood samples and discarded heart tissue.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl J Pepine, MD
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2015
First Posted
January 28, 2015
Study Start
June 1, 2013
Primary Completion
September 28, 2018
Study Completion
September 28, 2018
Last Updated
November 27, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share