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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376387
Recruitment Status : Enrolling by invitation
First Posted : March 3, 2015
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
Oregon Health and Science University
Kaiser Permanente
California Transplant Donor Network
Donor Network of Arizona
Gift of Life
Gift of Hope
LifeLink
New England Organ Bank
Life Gift Organ Donation
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kiran Khush, Stanford University

Brief Summary:
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.

Condition or disease
Heart Transplantation

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Evidence Based Evaluation and Acceptance of Donor Hearts for Transplantation
Actual Study Start Date : March 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Brain dead donors for heart transplant
Criteria

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 (+)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376387


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

Publications:

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Responsible Party: Kiran Khush, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02376387    
Other Study ID Numbers: NIH 41169
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020