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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01099982
Other study ID # IRB_00030622
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2008
Est. completion date January 2028

Study information

Verified date May 2024
Source University of Utah
Contact John Kirk
Phone 801-585-2944
Email john.kirk@hsc.utah.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date January 2028
Est. primary completion date January 2028
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States 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

Sponsors (4)

Lead Sponsor Collaborator
University of Utah Hunter Holmes McGuire VA Medical Center, Intermountain Health Care, Inc., VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in myocardial function 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 baseline and 3 months
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