Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Congestive Heart Failure

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01099982

IRB_00030622

Details and patient eligibility

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Advanced Heart Failure Therapy Group

Description:

Patients diagnosed with end stage heart failure undergoing either VAD implantation or heart transplantation.

Normal Hearts Group

Description:

Control samples will be obtained from individuals undergoing other types of cardiac surgery during which it is routine to discard some tissue intraoperatively.