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

This study is currently recruiting participants.
Verified July 2011 by University of Utah
Sponsor:
Collaborators:
Intermountain Health Care, Inc.
VA Salt Lake City Health Care System
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01099982
First received: April 6, 2010
Last updated: July 29, 2011
Last verified: July 2011
History of Changes
  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" (donors that their grafts won't be utilized) 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 data gathering and storing (database) endeavor with specific focus on the biological and genetic parameters of heart disease. 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Biospecimen Retention:   Samples With DNA

Serum and myocardial tissue.


Estimated Enrollment: 90
Study Start Date: September 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (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 as outlined in the following protocol. 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, ≥ 18 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:

  • Confirmed diagnosis of congestive heart failure
  • Age 13 years and older
  • Undergoing LVAD implantation
  • Undergoing Heart Transplantation.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099982

Contacts
Contact: Stavros G Drakos, M.D 801-585-0727 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 Hospital 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 Syatem Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Josef Stehlik, M.D, M.P.H     801-582-1565     josef.stehlik@hsc.utah.edu    
Sponsors and Collaborators
University of Utah
Intermountain Health Care, Inc.
VA Salt Lake City Health Care System
Investigators
Principal Investigator: Dean Y Li, MD, Ph.D University of Utah
  More Information

No publications provided

Responsible Party: Dean Y. Li, University of Utah
ClinicalTrials.gov Identifier: NCT01099982     History of Changes
Other Study ID Numbers: IRB_00030622
Study First Received: April 6, 2010
Last Updated: July 29, 2011
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 Diseases
Heart Failure
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013