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Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
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Purpose
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.
| Condition |
|---|
| Congestive Heart Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- Change in myocardial function [ Time Frame: baseline and 3 months ]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
Biospecimen Retention: Samples With DNA
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | January 2022 |
| Estimated Primary Completion Date: | January 2022 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- >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
Exclusion Criteria:
- Neither patient nor patient representative understands spoken English
- Neither patient nor patient's personal representative is willing to give written consent for participation.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01099982
| Contact: Stavros G Drakos, M.D., Ph.D. | 801-585-2340 | stavros.drakos@u2m2.utah.edu |
| United States, Utah | |
| Intermountain Medical Center | Recruiting |
| Murray, Utah, United States, 84157 | |
| Contact: Abdallah Kfoury, M.D. 801-507-7000 a.kfoury@imail.org | |
| University of Utah Health Sciences Center | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Dean Y Li, M.D, Ph.D 801-585-5505 dean.li@u2m2.utah.edu | |
| VA Salt Lake City Health Care System | Recruiting |
| Salt Lake City, Utah, United States, 84148 | |
| Contact: Josef Stehlik, M.D, M.P.H 801-582-1565 josef.stehlik@hsc.utah.edu | |
| United States, Virginia | |
| Hunter Holmes McGuire VA Medical Center | Not yet recruiting |
| Richmond, Virginia, United States, 23249 | |
| Contact: Gundars Katlaps, M.D. 804-675-5000 gundars.katlaps@va.gov | |
| Study Director: | Dean Y Li, M.D., Ph.D. | University of Utah |
| Principal Investigator: | Josef Stehlik, M.D., M.P.H. | University of Utah Health Sciences Center & VA Salt Lake City Health Care System |
| Study Director: | Stavros G Drakos, M.D., Ph.D. | University of Utah |
More Information
| Responsible Party: | Stavros Drakos, Principal Investigator, University of Utah |
| ClinicalTrials.gov Identifier: | NCT01099982 History of Changes |
| Other Study ID Numbers: |
IRB_00030622 |
| Study First Received: | April 6, 2010 |
| Last Updated: | October 5, 2016 |
Keywords provided by Stavros Drakos, University of Utah:
|
Congestive Heart Failure Left Ventricular Assist Device LVAD Myocardium |
Remodeling Microvasculature Fibrosis Cardiac Transplant |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on August 23, 2017