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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Congestive Heart Failure

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced Heart Failure Therapy Group<br>Patients diagnosed with end stage heart failure undergoing either VAD implantation or heart transplantation. | |
| Normal Hearts Group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive Heart Failure, Left Ventricular Assist Device, LVAD, Myocardium, Remodeling, Microvasculature, Fibrosis, Cardiac Transplant