Tests whether exercise testing affects a blood test in heart transplant patients
Compares a donor DNA blood test before and after exercise in heart transplant recipients.
Plain-language title generated from the registry record
Registry title: Cardiopulmonary Stress Testing (CPET) AlloSure Study
Key facts
- Where
- Dallas, United StatesSee the site
Where in United States
- Baylor Scott & White health research instituteDallas, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Baylor Research Institute
- Trial code
- NCT04656080
- Record updated
- 22 January 2026
- Original description
1. 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). 2. 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).Read full original descriptionShow less
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?
1. 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). 2. 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).
Inclusion: Post-orthotopic heart transplant patients.
Exclusion: 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; 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.