Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Recruiting · NCT01099982 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Utah
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
3 locations listed across 1 US state.
- Intermountain Medical Center - Murray, Utah, United States
- University of Utah Health Sciences Center - Salt Lake City, Utah, United States
- VA Salt Lake City Health Care System - Salt Lake City, Utah, United States