Evidence Based Evaluation and Acceptance of Donor Hearts for Transplantation (DHS)

October 19, 2021 updated by: Kiran Khush, Stanford University
The proposed research will provide evidence-based strategies for the evaluation and acceptance of donor hearts for transplantation. This is relevant to public health because judicious expansion of donor hearts used for transplantation will make this life-saving procedure available to a larger number of patients living with end-stage heart disease.

Study Overview

Status

Completed

Conditions

Detailed Description

The demand for donor hearts for transplantation far outstrips the supply; however, only one in three available cardiac grafts are used for transplantation. There are many reasons for graft non-use, but previous studies have failed to demonstrate consistent associations between donor characteristics, donor cardiac function, and adverse recipient outcomes. Thus, there is a critical need to standardize how cardiac allografts are evaluated and accepted for transplantation. The investigators long-term goal is to safely expand the use of available cardiac allografts without adversely affecting transplant recipient outcomes. The investigators propose to carefully characterize the current population of cardiac organ donors, particularly with regards to allograft function; to examine how decisions are made regarding graft acceptance for transplantation; and to systematically evaluate associations between donor characteristics and recipient outcomes. The investigators central hypothesis is that acceptable allografts for heart transplantation are being unnecessarily discarded, and the establishment of an evidence-based process for cardiac donor evaluation and acceptance will increase graft utilization rates while maintaining excellent clinical outcomes. In response to this need, the investigators propose a collaborative study with seven organ procurement organizations representing geographically diverse regions of the United States, to address the following specific aims: (1) To identify clinical correlates of graft function in potential donors being evaluated for heart transplantation. An existing online donor research database will be expanded for standardized collection of data on detailed donor characteristics, especially as pertains to cardiac allograft function. The investigators will perform expert core review of donor echocardiograms, including serial echocardiograms in donors with cardiac allograft dysfunction. Serial electrocardiograms and cardiac biomarkers (Troponin I and B-type natriuretic peptide) will also be studied; (2) To prospectively study reasons for cardiac allograft non-utilization for heart transplantation. Real-time data will be collected on specific reasons for allograft non-acceptance for transplantation in order to study graft acceptance practices and variation in graft utilization nationwide; and (3) To prospectively study associations between donor characteristics and recipient outcomes after heart transplantation. Data will be collected on recipient post-transplant length of hospitalization and survival to identify associations between donor predictors and recipient outcomes. This proposal is innovative because it focuses on an entirely different approach to donor-based research, thereby surmounting the limitations of prior investigations. Completion of the proposed study will have a positive impact by defining how to optimize the evaluation and use of available grafts for heart transplantation, thereby safely expanding the donor pool and increasing the number of heart transplants performed nationwide.

Study Type

Observational

Enrollment (Actual)

4333

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
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Donor Network of Arizona
    • California
      • Oakland, California, United States, 94607
        • California Transplant Donor Network
      • San Francisco, California, United States, 94115
        • Kaiser Permanente
      • Stanford, California, United States, 94305
        • Stanford University
    • Georgia
      • Norcross, Georgia, United States, 30071
        • LifeLink
    • Illinois
      • Itasca, Illinois, United States, 60143
        • Gift of Hope
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • New England Organ Bank
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • Gift of Life
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Texas
      • Houston, Texas, United States, 77054
        • LifeGift

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Brain dead donors for heart transplant

Description

Inclusion Criteria:

  1. Brain dead (beating heart)
  2. 18-65 years of age
  3. HIV (-)
  4. Donors authorized for research

Exclusion Criteria:

  1. Donors not authorized for research
  2. HIV (+)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Donor left ventricular ejection fraction, troponin, BNP, EKG changes (arrhythmias, QT prolongation, repolarization abnormalities, LVH, Q waves)
Time Frame: 5 years
To identify clinical correlates of cardiac function in potential donors being evaluated for heart transplantation.
5 years
Identify decline codes for donor hearts not accepted for transplant
Time Frame: 5 years
To prospectively study reasons for non-acceptance of hearts offered for transplantation.
5 years
Create a statistical tools (e.g. risk prediction model) for donor heart acceptance
Time Frame: 5 years
To develop clinical tools to assist transplant centers with real-time decisions regarding donor heart acceptance.
5 years

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)
Oregon Health and Science University
Kaiser Permanente
Gift of Life
California Transplant Donor Network
Donor Network of Arizona
Gift of Hope
LifeLink
New England Organ Bank
Life Gift Organ Donation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2015

Primary Completion (Actual)

May 26, 2020

Study Completion (Actual)

May 26, 2020

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • NIH 41169

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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