Terminal Graft Failure

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00208884
First received: September 13, 2005
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition
Orthotopic Heart Transplantation
Graft Failure

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Terminal Graft Failure: A Combined Pathologic and Clinical Study

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 19
Study Start Date: October 2003
Estimated Study Completion Date: November 2005
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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208884

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: William Mahle, MD Emory University and Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: William T. Mahle, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00208884     History of Changes
Other Study ID Numbers: 1001-2003
Study First Received: September 13, 2005
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
pediatric
orthotopic heart transplantation
graft failure

ClinicalTrials.gov processed this record on April 17, 2014