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

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ClinicalTrials.gov Identifier: NCT01099982
Recruitment Status : Recruiting
First Posted : April 8, 2010
Last Update Posted : October 27, 2017
Sponsor:
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

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Congestive Heart Failure

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.


Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : September 2008
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Serum and myocardial tissue.

Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099982


Contacts
Contact: Stavros G Drakos, M.D., Ph.D. 801-585-2340 stavros.drakos@u2m2.utah.edu

Locations
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Abdallah Kfoury, M.D.    801-507-7000    a.kfoury@imail.org   
University of Utah Health Sciences Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Dean Y Li, M.D, Ph.D    801-585-5505    dean.li@u2m2.utah.edu   
VA Salt Lake City Health Care System Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Josef Stehlik, M.D, M.P.H    801-582-1565    josef.stehlik@hsc.utah.edu   
United States, Virginia
Hunter Holmes McGuire VA Medical Center Not yet recruiting
Richmond, Virginia, United States, 23249
Contact: Gundars Katlaps, M.D.    804-675-5000    gundars.katlaps@va.gov   
Sponsors and Collaborators
University of Utah
Intermountain Health Care, Inc.
VA Salt Lake City Health Care System
Hunter Holmes McGuire VA Medical Center
Investigators
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
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Stavros Drakos, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT01099982     History of Changes
Other Study ID Numbers: IRB_00030622
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Stavros Drakos, University of Utah:
Congestive Heart Failure
Left Ventricular Assist Device
LVAD
Myocardium
 Remodeling
Microvasculature
Fibrosis
Cardiac Transplant

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases