Clinical trial NCT01099982: Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Official title: Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease, Effects of Mechanical Unloading on Myocardial Function and Structure in Humans
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Left Ventricular Assist Device
LVAD
Myocardium
Remodeling
Microvasculature
Fibrosis
Cardiac Transplant
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Intermountain Health Care, Inc.
name: VA Salt Lake City Health Care System
name: Hunter Holmes McGuire VA Medical Center
First posted: 2010-04-08
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Either gender, ≥ 13 years of age, any ethnicity, diagnosed with end stage heart failure undergoing either VAD implantation or heart transplantation.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in myocardial function
timeFrame: baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System
state: Utah
Study officials:
affiliation: University of Utah Health Sciences Center & VA Salt Lake City Health Care System
name: Stavros Drakos, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: