Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Part of paid clinical trials in Murray, Utah.
- Sponsor
- University of Utah
- Study ID
- NCT01099982
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Sep 30, 2008
- Status verified
- Jul 2025
- Primary completion
- Jan 31, 2028
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 300 participants (estimated)
Arms
- Arm: Advanced Heart Failure Therapy GroupPatients diagnosed with end stage heart failure undergoing either VAD implantation or heart transplantation.
- Arm: Normal Hearts GroupControl samples will be obtained from individuals undergoing other types of cardiac surgery during which it is routine to discard some tissue intraoperatively.
Primary Outcome Measure
Change in myocardial function [ Time Frame: baseline and 3 months ]
Central Contacts
- John Kirk801-585-2944
- Stavros Drakos, M.D., Ph.D.801-585-2340
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84157 | |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | |
| VA Salt Lake City Health Care System | Salt Lake City | Utah | 84148 |
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