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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,333

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.2 years study duration

First Submitted

Initial submission to the registry

February 17, 2015

Completed

12 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed

5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2020

Completed

Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

5.2 years

First QC Date

February 17, 2015

Last Update Submit

October 19, 2021

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (3)

Donor left ventricular ejection fraction, troponin, BNP, EKG changes (arrhythmias, QT prolongation, repolarization abnormalities, LVH, Q waves)
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
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
To develop clinical tools to assist transplant centers with real-time decisions regarding donor heart acceptance.
5 years

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Brain dead donors for heart transplant

You may qualify if:

Brain dead (beating heart)
years of age
HIV (-)
Donors authorized for research

You may not qualify if:

Donors not authorized for research
HIV (+)

Contact the study team to confirm eligibility.

Study Sites (10)

Donor Network of Arizona

Phoenix, Arizona, 85013, United States

Location

California Transplant Donor Network

Oakland, California, 94607, United States

Location

Kaiser Permanente

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

LifeLink

Norcross, Georgia, 30071, United States

Location

Gift of Hope

Itasca, Illinois, 60143, United States

Location

New England Organ Bank

Waltham, Massachusetts, 02451, United States

Location

Gift of Life

Ann Arbor, Michigan, 48108, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

LifeGift

Houston, Texas, 77054, United States

Location

Related Publications (10)

Khush KK, Menza R, Nguyen J, Zaroff JG, Goldstein BA. Donor predictors of allograft use and recipient outcomes after heart transplantation. Circ Heart Fail. 2013 Mar;6(2):300-9. doi: 10.1161/CIRCHEARTFAILURE.112.000165. Epub 2013 Feb 7.
PMID: 23392789BACKGROUND
Shah MR, Starling RC, Schwartz Longacre L, Mehra MR; Working Group Participants. Heart transplantation research in the next decade--a goal to achieving evidence-based outcomes: National Heart, Lung, And Blood Institute Working Group. J Am Coll Cardiol. 2012 Apr 3;59(14):1263-9. doi: 10.1016/j.jacc.2011.11.050.
PMID: 22464255BACKGROUND
Chen JM, Sinha P, Rajasinghe HA, Suratwala SJ, McCue JD, McCarty MJ, Caliste X, Hauff HM, John R, Edwards NM. Do donor characteristics really matter? Short- and long-term impact of donor characteristics on recipient survival, 1995-1999. J Heart Lung Transplant. 2002 May;21(5):608-10. doi: 10.1016/s1053-2498(01)00367-9.
PMID: 11983553BACKGROUND
De La Zerda DJ, Cohen O, Beygui RE, Kobashigawa J, Hekmat D, Laks H. Alcohol use in donors is a protective factor on recipients' outcome after heart transplantation. Transplantation. 2007 May 15;83(9):1214-8. doi: 10.1097/01.tp.0000261713.24244.ea.
PMID: 17496538BACKGROUND
Lima B, Rajagopal K, Petersen RP, Shah AS, Soule B, Felker GM, Rogers JG, Lodge AJ, Milano CA. Marginal cardiac allografts do not have increased primary graft dysfunction in alternate list transplantation. Circulation. 2006 Jul 4;114(1 Suppl):I27-32. doi: 10.1161/CIRCULATIONAHA.105.000737.
PMID: 16820584BACKGROUND
Nixon JL, Kfoury AG, Brunisholz K, Horne BD, Myrick C, Miller DV, Budge D, Bader F, Everitt M, Saidi A, Stehlik J, Schmidt TC, Alharethi R. Impact of high-dose inotropic donor support on early myocardial necrosis and outcomes in cardiac transplantation. Clin Transplant. 2012 Mar-Apr;26(2):322-7. doi: 10.1111/j.1399-0012.2011.01504.x. Epub 2011 Oct 10.
PMID: 21981698BACKGROUND
Patel ND, Weiss ES, Nwakanma LU, Russell SD, Baumgartner WA, Shah AS, Conte JV. Impact of donor-to-recipient weight ratio on survival after heart transplantation: analysis of the United Network for Organ Sharing Database. Circulation. 2008 Sep 30;118(14 Suppl):S83-8. doi: 10.1161/CIRCULATIONAHA.107.756866.
PMID: 18824775BACKGROUND
Smits JM, De Pauw M, de Vries E, Rahmel A, Meiser B, Laufer G, Zuckermann A. Donor scoring system for heart transplantation and the impact on patient survival. J Heart Lung Transplant. 2012 Apr;31(4):387-97. doi: 10.1016/j.healun.2011.11.005. Epub 2011 Dec 16.
PMID: 22177692BACKGROUND
Weiss ES, Allen JG, Kilic A, Russell SD, Baumgartner WA, Conte JV, Shah AS. Development of a quantitative donor risk index to predict short-term mortality in orthotopic heart transplantation. J Heart Lung Transplant. 2012 Mar;31(3):266-73. doi: 10.1016/j.healun.2011.10.004. Epub 2011 Nov 16.
PMID: 22093382BACKGROUND
Wever Pinzon O, Stoddard G, Drakos SG, Gilbert EM, Nativi JN, Budge D, Bader F, Alharethi R, Reid B, Selzman CH, Everitt MD, Kfoury AG, Stehlik J. Impact of donor left ventricular hypertrophy on survival after heart transplant. Am J Transplant. 2011 Dec;11(12):2755-61. doi: 10.1111/j.1600-6143.2011.03744.x. Epub 2011 Sep 11.
PMID: 21906259BACKGROUND

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 5 Years
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor of Medicine

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 3, 2015

Study Start

March 1, 2015

Primary Completion

May 26, 2020

Study Completion

May 26, 2020

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations

US(10)

Evidence Based Evaluation and Acceptance of Donor Hearts for Transplantation

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (10)

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (10)

Study Design

Study Record Dates

Locations