Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
NCT ID: NCT01099982
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2008-09-30
2028-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Advanced Heart Failure Therapy Group
Patients diagnosed with end stage heart failure undergoing either VAD implantation or heart transplantation.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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's personal representative is willing to give written consent for participation.
13 Years
ALL
No
Sponsors
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Intermountain Health Care, Inc.
OTHER
VA Salt Lake City Health Care System
FED
Hunter Holmes McGuire VA Medical Center
FED
University of Utah
OTHER
Responsible Party
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STAVROS G DRAKOS
Principal Investigator
Principal Investigators
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Stavros Drakos, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah Health Sciences Center & VA Salt Lake City Health Care System
Locations
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Intermountain Medical Center
Murray, Utah, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
VA Salt Lake City Health Care System
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Gatsiou A, Tual-Chalot S, Napoli M, Ortega-Gomez A, Regen T, Badolia R, Cesarini V, Garcia-Gonzalez C, Chevre R, Ciliberti G, Silvestre-Roig C, Martini M, Hoffmann J, Hamouche R, Visker JR, Diakos N, Wietelmann A, Silvestris DA, Georgiopoulos G, Moshfegh A, Schneider A, Chen W, Guenther S, Backs J, Kwak S, Selzman CH, Stamatelopoulos K, Rose-John S, Trautwein C, Spyridopoulos I, Braun T, Waisman A, Gallo A, Drakos SG, Dimmeler S, Sperandio M, Soehnlein O, Stellos K. The RNA editor ADAR2 promotes immune cell trafficking by enhancing endothelial responses to interleukin-6 during sterile inflammation. Immunity. 2023 May 9;56(5):979-997.e11. doi: 10.1016/j.immuni.2023.03.021. Epub 2023 Apr 25.
Other Identifiers
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IRB_00030622
Identifier Type: -
Identifier Source: org_study_id
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