AlloSure Test Characteristics in Immunologically Quiescent and Immunologically Active Heart Transplant Recipients: Does Maximal Cardiopulmonary Stress Testing Prior to Assay Preserve Test Specificity While Enhancing Sensitivity?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Baylor Research Institute
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- • Comparison of level of cell-free DNA
Study Overview
Brief Summary
- Cell-free DNA does not vary significantly as a function of the activity of immunologically quiescent cardiac transplant recipients, despite the metabolic demands of the transplanted organ. (The implication of the null result would be that no restrictions to patient activity, nor modification of cardiac rehabilitation prescription, would be necessary to maintain proper test characteristics of AlloSure testing).
- In immunologically active cardiac transplant allografts, exercise prior to assay of donor-derived cell-free DNA can be used to increase the sensitivity of the AlloSure test. (The implication of this would be that the optimal time-frame for drawing an Allosure may actually be post-exercise, and that window will be characterized).
Detailed Description
The specific research questioned aimed to be addressed with this proposed study are:
i. Are dd-cfDNA levels in heart transplant recipients independent of recent cardiopulmonary exercise? More specifically, does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfDNA (if so, then what is the time course for resolution back to baseline?) ii. If dd-cfDNA does not release to any significant degree with cardiac allografts with short donor-ischemic time, does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times? iii. In cardiac transplant recipients with medically stabilized, treated antibody-mediated rejection (AMR) and persistent dd-cfDNA elevation, does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfDNA, and again, with what time course?
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Post-orthotopic heart transplant patients
Exclusion Criteria
- •orthopedic, neurologic and/or any other limitations that do not allow for exercise testing on a treadmill or cycle ergometer;
- •individuals who require supplemental oxygen or have current permanent tracheostomies will be excluded from this study;
- •individuals who are discharged to a long-term acute care facility;
- •skilled nursing facility or with palliative care or hospice care will be excluded; (e) inmates and pregnant women;
- •(f) patients with antibody-mediate rejection that are not felt to be safe for cardiopulmonary stress testing.
Outcomes
Primary Outcomes
• Comparison of level of cell-free DNA
Time Frame: 10 days
Comparison of level of cell-free DNA
• Comparison of maximal oxygen consumption (VO2)
Time Frame: 10 days
• Comparison of maximal oxygen consumption (VO2)
• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
Time Frame: 10 days
• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
Secondary Outcomes
- • Time-dependent changes in high-sensitivity troponin-levels(10 days)