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

RECRUITING

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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.

Conditions:

Congestive Heart Failure

Study Start (Actual) 2008-09

Primary Completion (Estimated) 2028-01

Study Completion (Estimated) 2028-01

Enrollment (Estimated) 300

Study Type OBSERVATIONAL

Phase N/A

Locations:

📍 Murray, Utah, United States

📍 Salt Lake City, Utah, United States

Eligibility Criteria

Description

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: 13 Years to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2010-04-06
First Submitted that Met QC Criteria2010-04-06
First Posted2010-04-08

Study Record Updates

Last Update Submitted that Met QC Criteria2024-05-04
Last Update Posted2024-05-07
Last Verified2024-05