How cardiopulmonary exercise affects AlloSure donor-derived cell-free DNA in heart transplant recipients
Official title: 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?
Run by Baylor Research Institute · NCT04656080 · Data updated 2026-11-12
This will test whether exercise changes donor-derived cell-free DNA measured by AlloSure in people who have had heart transplants.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 27 (estimated) |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | May 21, 2020 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT04656080 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who have undergone orthotopic heart transplantation and can safely complete maximal CPET (no need for supplemental oxygen, no prohibiting orthopedic/neurologic limitations, and deemed safe from active unstable rejection) are ideal candidates.
✕Probably not a fit
Patients who cannot safely perform exercise testing—such as those requiring supplemental oxygen, with significant orthopedic or neurologic limitations, unstable rejection making CPET unsafe, those in long-term acute care or skilled nursing facilities, pregnant women, or inmates—are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study uses maximal cardiopulmonary exercise testing (CPET) to measure donor-derived cell-free DNA (dd-cfDNA) before and at multiple time points after exercise in orthotopic heart transplant recipients. It compares responses in immunologically quiescent grafts, grafts with prior longer donor ischemic times, and recipients with treated antibody-mediated rejection who have persistent dd-cfDNA elevation. The goal is to characterize whether exercise causes transient dd-cfDNA release and the time course for return to baseline. Findings will inform optimal timing of AlloSure sampling and whether exercise restrictions or modifications to cardiac rehabilitation are necessary.
Why it matters
Potential benefit: If successful, the results could allow more flexible exercise guidance and define the best time to draw AlloSure blood tests to improve detection of rejection.
How similar studies have gone: Donor-derived cell-free DNA is an established marker for transplant injury and rejection, but using exercise to intentionally change test sensitivity is a novel approach that is not well-established.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Baylor Scott & White health research institute
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Robert Gottlieb, MD — Bswri
- Study coordinator: Aayla Jamil, MBBS MPH
- Email: Aayla.Jamil@bswhealth.org
- Phone: 214-820-1675
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.