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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Utah
Sponsor:
Collaborators:
Intermountain Health Care, Inc.
VA Salt Lake City Health Care System
Hunter Holmes McGuire VA Medical Center
Information provided by (Responsible Party):
Josef Stehlik, University of Utah
ClinicalTrials.gov Identifier:
NCT01099982
First received: April 6, 2010
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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
Congestive Heart Failure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Biospecimen Retention:   Samples With DNA

Serum and myocardial tissue.


Estimated Enrollment: 300
Study Start Date: September 2008
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Josef Stehlik, Principle Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT01099982     History of Changes
Other Study ID Numbers: IRB_00030622
Study First Received: April 6, 2010
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014