Cardiopulmonary Stress Testing (CPET) AlloSure Study
- Conditions
- Transplant; Failure, HeartHeart Failure
- Interventions
- Behavioral: CPET exercise testing
- Registration Number
- NCT04656080
- Lead Sponsor
- Baylor Research Institute
- Brief 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).
- Detailed Description
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?
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 27
Post-orthotopic heart transplant patients
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 3 months post-heart transplant with AMR CPET exercise testing • 7 transplant recipients, at least 3 months post-transplant, with antibody-mediated rejection transplant recipients <1year without AMR CPET exercise testing 20 recent transplant recipients (\<1 year) without antibody-mediated rejection (AMR);
- Primary Outcome Measures
Name Time Method • Comparison of level of cell-free DNA 10 days Comparison of level of cell-free DNA
• Comparison of maximal oxygen consumption (VO2) 10 days • Comparison of maximal oxygen consumption (VO2)
• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise 10 days • Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
- Secondary Outcome Measures
Name Time Method • Time-dependent changes in high-sensitivity troponin-levels 10 days • Time-dependent changes in high-sensitivity troponin-levels
Trial Locations
- Locations (1)
Baylor Scott & White health research institute
🇺🇸Dallas, Texas, United States