- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01099982
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease, Effects of Mechanical Unloading on Myocardial Function and Structure in Humans
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stavros G Drakos, M.D., Ph.D.
- Phone Number: 801-585-2340
- Email: stavros.drakos@u2m2.utah.edu
Study Locations
-
-
Utah
-
Murray, Utah, United States, 84157
- Recruiting
- Intermountain Medical Center
-
Contact:
- Abdallah Kfoury, M.D.
- Phone Number: 801-507-7000
- Email: a.kfoury@imail.org
-
Salt Lake City, Utah, United States, 84148
- Recruiting
- VA Salt Lake City Health Care System
-
Contact:
- Josef Stehlik, M.D, M.P.H
- Phone Number: 801-582-1565
- Email: josef.stehlik@hsc.utah.edu
-
Salt Lake City, Utah, United States, 84132
- Recruiting
- University of Utah Health Sciences Center
-
Contact:
- Dean Y Li, M.D, Ph.D
- Phone Number: 801-585-5505
- Email: dean.li@u2m2.utah.edu
-
-
Virginia
-
Richmond, Virginia, United States, 23249
- Not yet recruiting
- Hunter Holmes McGuire VA Medical Center
-
Contact:
- Gundars Katlaps, M.D.
- Phone Number: 804-675-5000
- Email: gundars.katlaps@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline and 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00030622
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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