Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT01099982

Conditions

Congestive Heart Failure

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Congestive Heart Failure

Study ID

NCT01099982

Start date

Sep, 2008

Status verified date

Aug, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Change in myocardial function [ Time Frame: baseline and 3 months ]

Central Contacts and Locations

Central contacts

John Kirk

801-585-2944john.kirk@hsc.utah.edu

Stavros Drakos, M.D., Ph.D.

801-585-2340stavros.drakos@hsc.utah.edu

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84157

Contacts

Abdallah Kfoury, M.D.

801-507-7000a.kfoury@imail.org

University of Utah Health Sciences Center

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Stavros Drakos, M.D, Ph.D

801-585-2340stavros.drakos@hsc.utah.edu

VA Salt Lake City Health Care System

Recruiting

Salt Lake City, Utah, United States, 84148

Contacts

Stavros Drakos, M.D, Ph.D

801-585-2340stavros.drakos@hsc.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • Congestive Heart Failure
  • Left Ventricular Assist Device
  • LVAD
  • Myocardium
  • Remodeling
  • Microvasculature
  • Fibrosis
  • Cardiac Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-08-13.