Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 13 - Any |
| Updated: | 12/26/2018 |
| Start Date: | September 2008 |
| End Date: | January 2022 |
| Contact: | Stavros G Drakos, M.D., Ph.D. |
| Email: | stavros.drakos@u2m2.utah.edu |
| Phone: | 801-585-2340 |
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease, Effects of Mechanical Unloading on Myocardial Function and Structure in Humans
Hypothesis:
Tissue and serum samples collected from end-stage heart failure patients receiving left
ventricular assist device implantation (LVAD) or heart transplantation will provide
information regarding the basic science of heart disease. Tissue and serum samples collected
from a limited numbers of "healthy controls" (donor grafts that were not utilized for heart
transplantation) will serve as a comparator in research database projects.
Design:
This is a registry project; there are no investigational treatments, drug or procedures
associated with participation in registry activities. This project is an organized functional
data and tissue data gathering and storing (database) endeavor with specific focus on the
functional, structural, and molecular aspects of heart failure. Data collection will not
immediately influence the course of treatment for any patient.
Tissue and serum samples collected from end-stage heart failure patients receiving left
ventricular assist device implantation (LVAD) or heart transplantation will provide
information regarding the basic science of heart disease. Tissue and serum samples collected
from a limited numbers of "healthy controls" (donor grafts that were not utilized for heart
transplantation) will serve as a comparator in research database projects.
Design:
This is a registry project; there are no investigational treatments, drug or procedures
associated with participation in registry activities. This project is an organized functional
data and tissue data gathering and storing (database) endeavor with specific focus on the
functional, structural, and molecular aspects of heart failure. Data collection will not
immediately influence the course of treatment for any patient.
Brief description of procedures:
After informed consent is obtained from the patient, the blood samples will be obtained
either during a procedure from access lines inserted for the procedure or they will be drawn
when other ordered lab work is done at specific time points during the study. Tissue samples
will be obtained at the time of LVAD implantation by keeping the part of the left ventricular
apex that the surgeon is removing in order to place the inflow cannula of the LVAD. No extra
tissue sample, other than the tissue that has to be removed as a part of a standard LVAD,
will be collected.
After informed consent is obtained from the patient, the blood samples will be obtained
either during a procedure from access lines inserted for the procedure or they will be drawn
when other ordered lab work is done at specific time points during the study. Tissue samples
will be obtained at the time of LVAD implantation by keeping the part of the left ventricular
apex that the surgeon is removing in order to place the inflow cannula of the LVAD. No extra
tissue sample, other than the tissue that has to be removed as a part of a standard LVAD,
will be collected.
Inclusion Criteria:
- >18 years of age diagnosed with heart failure undergoing either LVAD implantation or
heart transplantation
- 13 to 18 years of age, specifically, older children with heart failure whose body mass
index is large enough to accommodate and LVAD
Exclusion Criteria:
- Neither patient nor patient representative understands spoken English
- Neither patient nor patient's personal representative is willing to give written
consent for participation.
We found this trial at
4
sites
5121 S Cottonwood St
Murray, Utah 84157
Murray, Utah 84157
(801) 507-7000
Phone: 801-507-7000
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