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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Stavros G Drakos, M.D., Ph.D.; Phone Number: 801-585-2340; Email: stavros.drakos@u2m2.utah.edu

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84157
      • Recruiting
      • Intermountain Medical Center
      • Contact: Abdallah Kfoury, M.D.; Phone Number: 801-507-7000; Email: a.kfoury@imail.org
    • Salt Lake City, Utah, United States, 84148
      • Recruiting
      • VA Salt Lake City Health Care System
      • Contact: Josef Stehlik, M.D, M.P.H; Phone Number: 801-582-1565; Email: josef.stehlik@hsc.utah.edu
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah Health Sciences Center
      • Contact: Dean Y Li, M.D, Ph.D; Phone Number: 801-585-5505; Email: dean.li@u2m2.utah.edu
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Not yet recruiting
      • Hunter Holmes McGuire VA Medical Center
      • Contact: Gundars Katlaps, M.D.; Phone Number: 804-675-5000; Email: gundars.katlaps@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in myocardial function	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	baseline and 3 months

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2008
• Primary Completion (Anticipated): January 1, 2028
• Study Completion (Anticipated): January 1, 2028

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 6, 2010
• First Posted (Estimate): April 8, 2010

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Fibrosis; Congestive Heart Failure; Remodeling; Left Ventricular Assist Device; LVAD; Microvasculature; Myocardium; Cardiac Transplant
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Failure; Heart Diseases
• Other Study ID Numbers: IRB_00030622