Cytokine Profiling Post-Heart Transplant

NCT ID: NCT01643564

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-06-30

Brief Summary

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Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft dysfunction.

Detailed Description

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Conditions

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Cardiac Transplant

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

Heart Transplant Recipients with Unexplained Graft Dysfunction

No interventions assigned to this group

Group 2

Normal Control

No interventions assigned to this group

Group 3

Class III-IV Heart Failure

No interventions assigned to this group

Group 4

Heart Transplant Recipients with Normal Graft Function

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Group 1

* 18 years and older
* Cardiac Transplant recipient with graft dysfunction of unknown etiology

Group 2

* 18 years or older
* No history of heart failure or cardiac transplantation Group 3
* 18 years or older
* Class II-IV heart failure Group 4
* 18 years or older
* Heart Transplant 6 months or greater prior to blood draw
* No graft dysfunction

Exclusion Criteria

Group 1 Heart Transplant with Unexplained Graft Dysfunction

* Cellular or antibody-mediated cardiac allograft dysfunction

Group 2 Normal Control group

* Active infection within 1 month of blood draw
* Known Inflammatory Disease

Group 3 Heart Failure Group

* Active infection within 1 month of blood draw
* Known Inflammatory Disease

Group 4 Heart Transplant with Normal Graft Function Group

* Active infection within 1 month of blood draw
* Known graft dysfunction
* Known Inflammatory Disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter M Eckman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Other Identifiers

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1111M06547

Identifier Type: -

Identifier Source: org_study_id

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