Congestive Heart Failure
Conditions
Keywords
Congestive Heart Failure, Left Ventricular Assist Device, LVAD, Myocardium, Remodeling, Microvasculature, Fibrosis, Cardiac Transplant
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Utah
Intermountain Health Care, Inc.
VA Salt Lake City Health Care System
Hunter Holmes McGuire VA Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in myocardial function | baseline and 3 months | Myocardial function, measured by left ventricular ejection fraction, will be assessed pre-LVAD implant (baseline) and compared with myocardial function assessed at 3 months post-LVAD implant |
Countries
United States
Contacts
CONTACTJohn Kirk
CONTACTStavros Drakos, M.D., Ph.D.
PRINCIPAL_INVESTIGATORStavros Drakos, M.D., Ph.D.
University of Utah Health Sciences Center & VA Salt Lake City Health Care System
Outcome results
None listed