Evidence Based Evaluation and Acceptance of Donor Hearts for Transplantation

Completed

• Conditions: Heart Transplantation

• Registration Number: NCT02376387
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-24
• Study Start: 2015-03
• Study First Posted: 2015-03-03
• Primary Completion: 2020-05-26
• Study Completion: 2020-05-26
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4333

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (10)

Gift of Life; 🇺🇸 Ann Arbor, Michigan, United States

California Transplant Donor Network; 🇺🇸 Oakland, California, United States

Donor Network of Arizona; 🇺🇸 Phoenix, Arizona, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Gift of Hope; 🇺🇸 Itasca, Illinois, United States

Stanford University; 🇺🇸 Stanford, California, United States

LifeGift; 🇺🇸 Houston, Texas, United States

New England Organ Bank; 🇺🇸 Waltham, Massachusetts, United States

LifeLink; 🇺🇸 Norcross, Georgia, United States

Kaiser Permanente; 🇺🇸 San Francisco, California, United States