Heart Failure Clinical Trial

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

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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

300

Study ID:

NCT01099982

Recruitment Status:

Recruiting

Sponsor:

University of Utah

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There are 4 Locations for this study

See Locations Near You

Intermountain Medical Center
Murray Utah, 84157, United States More Info
Abdallah Kfoury, M.D.
Contact
801-507-7000
[email protected]
University of Utah Health Sciences Center
Salt Lake City Utah, 84132, United States More Info
Dean Y Li, M.D, Ph.D
Contact
801-585-5505
[email protected]
VA Salt Lake City Health Care System
Salt Lake City Utah, 84148, United States More Info
Josef Stehlik, M.D, M.P.H
Contact
801-582-1565
[email protected]
Hunter Holmes McGuire VA Medical Center
Richmond Virginia, 23249, United States More Info
Gundars Katlaps, M.D.
Contact
804-675-5000
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

300

Study ID:

NCT01099982

Recruitment Status:

Recruiting

Sponsor:


University of Utah

How clear is this clinincal trial information?

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