Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
ConditionCongestive Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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
Disqualifiers
Neither patient nor patient representative understands spoken English
Neither patient nor patient's personal representative is willing to give written consent for participation.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: Advanced Heart Failure Therapy Group
Group B: Normal Hearts Group
Trial outcomes
Primary outcomes
1
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
Time frame
baseline and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
Intermountain Health Care, Inc.
Collaborator
VA Salt Lake City Health Care System
Collaborator
Hunter Holmes McGuire VA Medical Center
Collaborator
Source ClinicalTrials.gov