BIIR Gene to Manage Heart Allograft Patients

Cardiac Transplant Failure Clinical Trial

Official title:

Application of In-House Developed Nanomedicine Technology for Diagnosis and Management of Post-Transplant Heart Allograft Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929785
• Other study ID #: 009-265
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: January 12, 2016
• Start date: December 2009
• Est. completion date: November 2013

Study information

• Verified date: January 2016
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This is a single center observational study. Duration of the study is 1 year. Participants will be followed in 2 groups. Group 1 will include all patients who have undergone a heart transplant, through the first year post transplant. Group 2 will include heart transplant recipients from 1 year to 2 years post transplant. Groups will be enrolled simultaneously. It is anticipated each group will have 25 participants.

Description:

Application of the BIIR gene expression profile approach to heart transplantation clinical diagnostic issues is likely to create new means to detect rejection at the earliest stages, to help prevent progression through earlier treatment, to discover new avenues targets for treatment of heart graft rejection, and to reduce the cost of post-transplant health care

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 73 Years

Eligibility

Inclusion Criteria:

• Patients who will have or have already received a heart transplant.

• Patients who have no other transplant history.

• Men and Women ages 18 to 73

Exclusion Criteria:

• Patients who are pregnant or lactating will not be eligible for this protocol.

• Patients who are cognitively impaired

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Transplant Failure

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To correlate the BUMC GEP results with AlloMap results.	To correlate the BUMC GEP results with with AlloMap results. The Investigators will retrospectively select longitudinal samples collected in Aim #1 from patients who had normal vs. high AlloMap scores	2 years	No
Other	To determine whether immune response status, as reflected by donor specific antibody response adn Cylex ImmuKnow assay, alters the GEP in heart transplant patients.	To determine whether immune response status, as reflected by donor specific antibody response and Cylex ImmuKnow assay, alters the GEP heart transplant patients.	2 years	No
Primary	To systematically collect blood samples from heart allograft recipients who are 0-2 years post-transplant to create a repository for genomic research.	To systematically collect blood samples from heart allograft recipients who are 0 -2 years post-transplant for eventual screening of blood cell gene activity, in order to identify diagnostically useful biomarkers that can help distinguish among multiple possible clinical presentation, e.g., acute rejection, antibody mediated rejection, infection, coronary artery disease, a variety of potential causes for heart dysfunction.).	2 years	No
Secondary	Recent work using our gene expression profiling (GEP) has shown that peripheral blood cells display a unique GEP that is 90% accurate for detection of acute rejection in liver transplant patients & hopefully hearts as well.	Recent work using our gene expression profiling (GEP) has shown that peripheral blood cells display a unique GEP that is 90% accurate for detection of acute rejection in liver transplant patients. The Investigators hypothesize that heart allograft recipients will display a similar pattern (Aim #2). The Investigators will retrospectively select longitudinal samples collected in Aim #1 from patients who did not experience rejection and from those who did, in order to determine if their GEP correlates with what we have observed for liver patients.	2 years	No