NCT04656080Recruiting
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?
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 27 (estimated)
- First submitted
- 6 Oct 2020
- Start date
- 21 May 2020
- Primary completion date
- Dec 2027
- Lead sponsor
- Baylor Research Institute
- Diseases
- Heart failure
- NCT number
- NCT04656080
What you commit to
- Study type: Observational
- Planned participants: 27
- From 21 May 2020 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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;
Who the study is looking for
- Post-orthotopic heart transplant patients
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor Scott & White health research institute Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.