Actively Recruiting

Age: 13Years +
All Genders
ID01099982

Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease, Effects of Mechanical Unloading on Myocardial Function and Structure in Humans

Led by University of Utah · Updated on 2025-07-15

300

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

I

Intermountain Health Care, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating changes in heart tissue and blood in patients with advanced heart disease, focusing on those with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation or heart transplantation. The study aims to collect tissue and serum samples to better understand the basic science of heart disease. Samples from healthy donor hearts not used for transplantation will serve as comparison controls. This observational registry project does not involve any investigational drugs or procedures and focuses on gathering functional, structural, and molecular data related to heart failure. Participants in the advanced heart failure group will have tissue samples collected during their LVAD implantation surgery from the portion of the left ventricular apex removed as part of the procedure. Blood samples will be drawn at specific times during the study, either during scheduled procedures or alongside other lab work. Control samples will be obtained from patients undergoing other cardiac surgeries where tissue is routinely discarded. No additional tissue beyond standard surgical removal will be collected. During the study, participants will provide consent and have blood samples taken at defined time points. Researchers will monitor changes in myocardial function from baseline to three months after procedures. The project stores and organizes collected data and tissue samples for future research but does not affect current treatment plans. The study involves ongoing monitoring and data collection, with overall participation duration varying based on individual procedures and follow-up schedules.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years diagnosed with heart failure undergoing LVAD implantation or heart transplantation
  • Children aged 13 to 18 years with heart failure and body size suitable for LVAD placement
Not Eligible

You will not qualify if you...

  • Neither the patient nor their representative understands spoken English
  • Neither the patient nor their representative is willing to provide written consent for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Day of surgery

Blood and tissue samples are collected during cardiac surgery procedures as part of routine care.

1 visit (in-person)

Long-term Monitoring

Duration - 3 months

Participants are observed for changes in myocardial function over time after surgery.

1 follow-up visit

Trial Site Locations

Total: 3 locations

1

Intermountain Medical Center

Murray, Utah, United States, 84157

Actively Recruiting

2

University of Utah Health Sciences Center

Salt Lake City, Utah, United States, 84132

Actively Recruiting

3

VA Salt Lake City Health Care System

Salt Lake City, Utah, United States, 84148

Actively Recruiting

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Research Team

J

John Kirk

S

Stavros Drakos, M.D., Ph.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

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https://pubmed.ncbi.nlm.nih.gov/37100060