RecruitingRecruiting
Cardiopulmonary Stress Testing (CPET) AlloSure Study
NCT04656080 · Baylor Research Institute
In plain English
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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?
About this study
The specific research questioned aimed to be addressed with this proposed study are:
i. Are dd-cfDNA levels in heart transplant recipients independent of recent cardiopulmonary exercise? More specifically, does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfDNA (if so, then what is the time course for resolution back to baseline?) ii. If dd-cfDNA does not release to any significant degree with cardiac allografts with short donor-ischemic time, does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times? iii. In cardiac transplant recipients with medically stabilized, treated antibody-mediated rejection (AMR) and persistent dd-cfDNA elevation, does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfDNA, and again, with what time course?
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.
Study design
Enrollment target: 27 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-05-21
Estimated completion: 2027-12
Last updated: 2026-01-22
Interventions
Behavioral: CPET exercise testing
Primary outcomes
- • • Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise (10 days)
- • • Comparison of maximal oxygen consumption (VO2) (10 days)
- • • Comparison of level of cell-free DNA (10 days)
Sponsor
Baylor Research Institute · other
Contacts & investigators
ContactAayla Jamil, MBBS MPH · contact · Aayla.Jamil@bswhealth.org · 214-820-1675
InvestigatorRobert Gottlieb, MD · principal_investigator, BSWRI
All locations (1)
Baylor Scott & White health research instituteRecruiting
Dallas, Texas, United States