Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
1 other identifier
observational
300
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2008
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 6, 2010
CompletedFirst Posted
Study publicly available on registry
April 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
July 15, 2025
July 1, 2025
19.3 years
April 6, 2010
July 9, 2025
Conditions
Keywords
Outcome Measures
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
baseline and 3 months
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- \>18 years of age diagnosed with heart failure undergoing either LVAD implantation or heart transplantation
- to 18 years of age, specifically, older children with heart failure whose body mass index is large enough to accommodate and LVAD
You may not qualify if:
- Neither patient nor patient representative understands spoken English
- Neither patient nor patient's personal representative is willing to give written consent for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Intermountain Health Care, Inc.collaborator
- VA Salt Lake City Health Care Systemcollaborator
- Hunter Holmes McGuire VA Medical Centercollaborator
Study Sites (3)
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
Related Publications (1)
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.
PMID: 37100060DERIVED
Biospecimen
Serum and myocardial tissue.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stavros Drakos, M.D., Ph.D.
University of Utah Health Sciences Center & VA Salt Lake City Health Care System
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 6, 2010
First Posted
April 8, 2010
Study Start
September 1, 2008
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
July 15, 2025
Record last verified: 2025-07