RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2008-09
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01099982

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>18 years of age diagnosed with heart failure undergoing either LVAD implantation or heart transplantation
  2. * 13 to 18 years of age, specifically, older children with heart failure whose body mass index is large enough to accommodate and LVAD
  1. * Neither patient nor patient representative understands spoken English
  2. * Neither patient nor patient's personal representative is willing to give written consent for participation.

Contacts and Locations

Study Contact

John Kirk
CONTACT
801-585-2944
john.kirk@hsc.utah.edu
Stavros Drakos, M.D., Ph.D.
CONTACT
801-585-2340
stavros.drakos@hsc.utah.edu

Principal Investigator

Stavros Drakos, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
University of Utah Health Sciences Center & VA Salt Lake City Health Care System

Study Locations (Sites)

Intermountain Medical Center
Murray, Utah, 84157
United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
United States
VA Salt Lake City Health Care System
Salt Lake City, Utah, 84148
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Stavros Drakos, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, University of Utah Health Sciences Center & VA Salt Lake City Health Care System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2008-09
Study Completion Date2028-01

Study Record Updates

Study Start Date2008-09
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Congestive Heart Failure