Recruiting

NCT Number: NCT01099982

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

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.

Recruiting

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Fibrosis Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Medical Center, Murray, Utah, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Change in myocardial function

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

John Kirk

CONTACT

[email protected]

801-585-2944

Stavros Drakos, M.D., Ph.D.

CONTACT

[email protected]

801-585-2340

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

Hunter Holmes McGuire VA Medical Center
Intermountain Health Care, Inc.
VA Salt Lake City Health Care System

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2028
Study completion: 2028
First posted: Apr 8, 2010
Registry last updated: Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed