Congestive Heart Failure Clinical Trial
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
NCT number | NCT01099982 |
Other study ID # | IRB_00030622 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 2008 |
Est. completion date | January 2028 |
Verified date | May 2024 |
Source | University of Utah |
Contact | John Kirk |
Phone | 801-585-2944 |
john.kirk[@]hsc.utah.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | January 2028 |
Est. primary completion date | January 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
University of Utah | Hunter Holmes McGuire VA Medical Center, Intermountain Health Care, Inc., VA Salt Lake City Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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