Cytokine Profiling Post-Heart Transplant

Cytokine Profiling of Cardiac Transplant Recipients

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

Study Overview

• Status: Terminated
• Conditions: Cardiac Transplant

• Study Type: Observational
• Enrollment (Actual): 34

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Cardiology Clinic and inpatient service. Normal controls are volunteers from within the community.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Group 1; Heart Transplant Recipients with Unexplained Graft Dysfunction
Group 2; Normal Control
Group 3; Class III-IV Heart Failure
Group 4; Heart Transplant Recipients with Normal Graft Function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection	Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection	12 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Peter M Eckman, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (Estimated): July 18, 2012

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cytokines; Transplant; Graft Dysfunction
• Other Study ID Numbers: 1111M06547