Clinical Trial

Cardiopulmonary Stress Testing (CPET) AlloSure Study

Recruiting
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Summary
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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2020-11-30; most recent amendment 2026-01-20.
Status change: Not Yet Recruiting → Recruiting 2022-01-27
Trial Details
NCT Number NCT04656080
Lead Sponsor Baylor Research Institute
Conditions Heart Failure, Transplant; Failure, Heart
Enrollment 27 participants
Start Date 2020-05-21
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-22