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| Name | Class |
|---|---|
| Intermountain Health Care, Inc. | OTHER |
| VA Salt Lake City Health Care System | FED |
| Hunter Holmes McGuire VA Medical Center | FED |
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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.
Brief description of procedures:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Stavros Drakos, M.D., Ph.D. | University of Utah Health Sciences Center & VA Salt Lake City Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Recruiting | Murray | Utah | 84157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37100060 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Serum and myocardial tissue.
| University of Utah Health Sciences Center | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| VA Salt Lake City Health Care System | Recruiting | Salt Lake City | Utah | 84148 | United States |
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