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

This study is currently recruiting participants.
Verified October 2017 by Stavros Drakos, University of Utah
Sponsor:
ClinicalTrials.gov Identifier:
NCT01099982
First Posted: April 8, 2010
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Intermountain Health Care, Inc.
VA Salt Lake City Health Care System
Hunter Holmes McGuire VA Medical Center
Information provided by (Responsible Party):
Stavros Drakos, University of Utah
April 6, 2010
April 8, 2010
October 27, 2017
September 2008
January 2022   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01099982 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease, Effects of Mechanical Unloading on Myocardial Function and Structure in Humans

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Serum and myocardial tissue.
Non-Probability Sample

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.

Congestive Heart Failure
Not Provided
  • Advanced Heart Failure Therapy Group
    Patients diagnosed with end stage heart failure undergoing either VAD implantation or heart transplantation.
  • Normal Hearts Group
    Control samples will be obtained from individuals undergoing other types of cardiac surgery during which it is routine to discard some tissue intraoperatively.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
January 2022
January 2022   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact: Stavros G Drakos, M.D., Ph.D. 801-585-2340 stavros.drakos@u2m2.utah.edu
United States
 
 
NCT01099982
IRB_00030622
Yes
Not Provided
Not Provided
Stavros Drakos, University of Utah
University of Utah
  • Intermountain Health Care, Inc.
  • VA Salt Lake City Health Care System
  • Hunter Holmes McGuire VA Medical Center
Study Director: Dean Y Li, M.D., Ph.D. University of Utah
Principal Investigator: Josef Stehlik, M.D., M.P.H. University of Utah Health Sciences Center & VA Salt Lake City Health Care System
Study Director: Stavros G Drakos, M.D., Ph.D. University of Utah
University of Utah
October 2017