Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01099982|
Recruitment Status : Recruiting
First Posted : April 8, 2010
Last Update Posted : January 9, 2020
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.
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 or disease|
|Congestive Heart Failure|
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 :||Observational|
|Estimated Enrollment :||300 participants|
|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|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099982
|Contact: Stavros G Drakos, M.D., Ph.D.||firstname.lastname@example.org|
|United States, Utah|
|Intermountain Medical Center||Recruiting|
|Murray, Utah, United States, 84157|
|Contact: Abdallah Kfoury, M.D. 801-507-7000 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|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|