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BIIR Gene to Manage Heart Allograft Patients

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ClinicalTrials.gov Identifier: NCT01929785
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Brief 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.

Condition or disease
Cardiac Transplant Failure

Detailed 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

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Application of In-House Developed Nanomedicine Technology for Diagnosis and Management of Post-Transplant Heart Allograft Patients
Study Start Date : December 2009
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Pre and Post Transplant
Research blood samples will be drawn pre-transplant, and at monthly post transplant visits at times corresponding to post-transplant, standard of care ImmKnowo and AlloMap clinical testing. A minimum of 12 visits per patient is expected
One year post transplant
The second group will include heart transplant recipients at one year post transplant who consent to participate in the study. Research blood samples will be drawn at quarterly post transplant visits (standard of care in Year 2 post transplant) corresponding to ImmunKnow and AlloMap testing. A minimum of 4 visits per patient is expected.



Primary Outcome Measures :
  1. To systematically collect blood samples from heart allograft recipients who are 0-2 years post-transplant to create a repository for genomic research. [ Time Frame: 2 years ]
    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.).


Secondary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]
    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.


Other Outcome Measures:
  1. To correlate the BUMC GEP results with AlloMap results. [ Time Frame: 2 years ]
    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. To determine whether immune response status, as reflected by donor specific antibody response adn Cylex ImmuKnow assay, alters the GEP in heart transplant patients. [ Time Frame: 2 years ]
    To determine whether immune response status, as reflected by donor specific antibody response and Cylex ImmuKnow assay, alters the GEP heart transplant patients.


Biospecimen Retention:   Samples With DNA
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
heart transplant patients from Baylor University Medical Center,Dallas
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929785


Locations
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United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Study Chair: Shelley Hall, MD Baylor Health Care System
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01929785    
Other Study ID Numbers: 009-265
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Keywords provided by Baylor Research Institute:
post tranplant heart allograft