Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01099982
• Other study ID #: IRB_00030622
• Status: Recruiting
• Start date: September 2008
• Est. completion date: January 2028

Study information

• Verified date: May 2023
• Source: University of Utah
• Contact: Stavros G Drakos, M.D., Ph.D.
• Phone: 801-585-2340
• Email: stavros.drakos[@]u2m2.utah.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Diseases
• Heart Failure

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
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

Sponsors (4)

Lead Sponsor	Collaborator
University of Utah	Hunter Holmes McGuire VA Medical Center, Intermountain Health Care, Inc., VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

Outcome

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