Cardiopulmonary Stress Testing (CPET) AlloSure Study
Recruiting · NCT04656080 · Observational (researchers observe without assigning treatment) · Lead sponsor: Baylor Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Baylor Scott & White health research institute - Dallas, Texas, United States