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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
13 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects and stores heart tissue, blood samples, and health data to learn about severe heart failure. It is for people with heart failure who are getting a heart pump or heart transplant, including some teens. It does not test any new treatments, drugs, or procedures.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults older than 18 with heart failure who are getting a heart transplant or an LVAD, a pump that helps the heart move blood.
  • Teens ages 13 to 18 with heart failure whose body size is large enough for an LVAD heart pump.

Who can't join

  • Neither you nor the person who can make decisions for you understands spoken English.
  • Neither you nor the person who can make decisions for you is willing to give written permission to join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

UT