Terminal Graft Failure

November 25, 2013 updated by: William T. Mahle, MD, Emory University

Terminal Graft Failure: A Combined Pathologic and Clinical Study

One of the risks associated with heart transplantation is failure of the graft. A graft is where the new heart is attached to the original vessels in the body. Approximately 10% of children suffer graft failure which, leads to heart failure and possible death. The problem is that we do not know some of the causes of graft failure thus, it is difficult to diagnose early and treat. Due to graft failure, lots of children are placed back on the transplant list and receive another new heart.

In this study, we plan to perform a retrospective chart review looking to see if we can correlate graft failure with a problem with the vessels called coronary allograft vasculopathy or rejection. In order to do this, we will collect data from patient's charts that have been diagnosed with graft failure and compare their clinical presentation/data to pathology reports of the explanted hearts from these children. Explanted hearts are the old transplanted hearts that are removed in order to put a new heart into the body. Explanted hearts at our institution are always sent to pathology for analysis thus it will be quite easy to perform this review.

Study Overview

Status

Terminated

Conditions

Detailed Description

The objectives are to describe the pathology findings from the examination of the explanted heart and correlate them with clinical variables such as catheterization data.

Children's Healthcare of Atlanta performs approximately 12-15 heart transplants a year. To date, there have been 19 re-transplantations for late graft failure at Children's. The pathologic and clinical records of these 19 patients will be studied. All data collected will be entered into a database for future analysis.

Data Collection

A retrospective review of standard pathology findings from the examination of the explanted hearts will be conducted in order to determine the following:

  1. Evidence of CAV (coronary allograft vasculopathy)
  2. Evidence of Endocardial fibroelastosis
  3. Evidence of Rejection (acute and chronic)
  4. Evidence of Myocardial infarction
  5. Evidence of Fibrosis
  6. Evidence of Fatty infiltration

A retrospective review of patient charts will also be utilized to compare the pathologic findings to clinical data obtained prior to re-transplantation. The following information will be collected:

  1. Type of transplant method
  2. Patient age at time of transplant
  3. Echocardiographic Data including Tissue Doppler Imaging (if available)

  4. Catheterization data

    1. CAV as identified by coronary angiography
    2. Ventricular end-diastolic pressure
    3. Cardiac index
    4. Ventricular ejection fraction
  5. Clinical rejection history

Study Type

Observational

Enrollment

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • retransplanted at Children's Healthcare of Atlanta for late graft failure

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: William Mahle, MD, Emory University and Children's Healthcare of Atlanta

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 Major Dates

Study Start

October 1, 2003

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1001-2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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