BIIR Gene to Manage Heart Allograft Patients

NCT01929785 | Completed DMC

• 1 other identifier: 009-265
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Transplant Failure

Keywords

post tranplant heart allograft

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (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.

  2 years

Other Outcomes (2)

• To correlate the BUMC GEP results with AlloMap results.

  2 years

• To determine whether immune response status, as reflected by donor specific antibody response adn Cylex ImmuKnow assay, alters the GEP in heart transplant patients.

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

heart transplant patients from Baylor University Medical Center,Dallas

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

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

Study Officials

• Shelley Hall, MD

  Baylor Health Care System

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: August 28, 2013
• Study Start: December 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

US (1)