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Cardiopulmonary Stress Testing (CPET) AlloSure Study
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?
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: Post-orthotopic heart transplant patients Exclusion Criteria: 1. orthopedic, neurologic and/or any other limitations that do not allow for exercise testing on a treadmill or cycle ergometer; 2. individuals who require supplemental oxygen or have current permanent tracheostomies will be excluded from this study; 3. individuals who are discharged to a long-term acute care facility; 4. 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.
About the study
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).
What is being tested
- CPET exercise testing (behavioral)
Sponsor: Baylor Research Institute · Participants: 27 · Started: May 21, 2020
Contact the study team
- Aayla Jamil, MBBS MPH · Phone: 214-820-1675
Official record on ClinicalTrials.gov — NCT04656080
Locations in the U.S.
| Texas | Baylor Scott & White health research institute, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.