What this study is
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 details
- 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
- Sponsor
- University of Utah
- Conditions
- Congestive Heart Failure
- Enrolling
- 300 people
- Starts
- 2008-09
- Est. completion
- 2030-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 13 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- >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
You can't join if
- Neither patient nor patient representative understands spoken English
- Neither patient nor patient's personal representative is willing to give written consent for participation.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for 2 of 3 open sites
- Stavros Drakos, M.D, Ph.D · Contact801-585-2340stavros.drakos@hsc.utah.edu
Intermountain Medical Center
Murray, Utah, United States
- Abdallah Kfoury, M.D. · Contact801-507-7000a.kfoury@imail.org
RecruitingUniversity of Utah Health Sciences Center
Salt Lake City, Utah, United States
RecruitingVA Salt Lake City Health Care System
Salt Lake City, Utah, United States
Recruiting
Study team
Sponsor
University of Utah
Study ID IRB_00030622
Principal investigator
Stavros Drakos, M.D., Ph.D.
University of Utah Health Sciences Center & VA Salt Lake City Health Care System
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.