NCT02348515

Cardiovascular Disease Protection Tissue

Effects of ACE2/Ang-(1-7) on Cardiac Progenitor Cells From Heart Failure Patients and Explant Control

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As a participant undergoes a clinically indicated heart transplant, or a left ventricular assist device (LVAD) implantation, or a right heart biopsy, or atrial fibrillation surgery, or right atria cannulation, the following tissue samples will be collected: In the subjects undergoing orthotopic heart transplant (n=20), failed myocardial tissue samples will be collected from the diseased heart. For subjects undergoing left ventricular assist device implantation (n=60), small samples will be collected from the apex core (that would be routinely discarded at the time of the implantation procedure). For heart transplant subjects undergoing clinically indicated right heart biopsy (n=20), the collection of multiple samples including, excess myocardial biopsy samples that will not be utilized by pathology. For subjects undergoing any heart surgery (n=80), the collection of 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 collection of 20ml (about one tablespoon) of blood will be taken from all subjects to analyze progenitor/inflammatory cells and inflammation cytokines and pertinent medical history.

Conditions

• Myocardial Ischemia

Interventions

Type	Name	Description
PROCEDURE	Heart failure or coronary disease	Small samples collected from the apex core in the heart. In addition, blood samples will be taken.
PROCEDURE	Heart transplant patients	Heart samples collected including, excess myocardial biopsy samples. In addition, blood samples will be taken.
PROCEDURE	Orthotopic Heart Transplant Patients	Myocardial tissue samples collected from the diseased heart. In addition, blood samples will be taken.
PROCEDURE	Heart Surgery Patients	Heart samples will be collected from the left atrial appendages. In addition, blood samples will be taken.
PROCEDURE	Blood Draw	All subjects will have 20 ml of blood drawn for further analysis.

Timeline

• Start date: 2013-06-01
• Primary completion: 2018-09-28
• Completion: 2018-09-28
• First posted: 2015-01-28
• Last updated: 2018-11-27

Locations

1 site across 1 country: United States