Cardiovascular Disease Protection Tissue



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/29/2018
Start Date:June 2013
End Date:September 28, 2018

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

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.

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.

Inclusion Criteria:

- heart transplant surgery

- left ventricular assist device implantation

- heart surgery required for atrial fibrillation and right atria cannulation

Exclusion Criteria:

- We are collecting discarded tissues following surgery. There is no exclusion criteria
for this study.
We found this trial at
1
site
Gainesville, Florida 32610
Phone: 352-273-9308
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mi
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Gainesville, FL
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