Heart Failure, Transplant; Failure, Heart
Conditions
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?
Interventions
BEHAVIORALCPET exercise testing
* The cardiopulmonary exercise testing (CPET) is done. * EKG testing will be done as part of the CPET test. Allosure testing will be done at baseline and then at 1 hr, 4 hrs, 1 day, 7 days after CPET.
Sponsors
Baylor Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise | 10 days | • Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise |
| • Comparison of maximal oxygen consumption (VO2) | 10 days | • Comparison of maximal oxygen consumption (VO2) |
| • Comparison of level of cell-free DNA | 10 days | Comparison of level of cell-free DNA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Time-dependent changes in high-sensitivity troponin-levels | 10 days | • Time-dependent changes in high-sensitivity troponin-levels |
Countries
United States
Contacts
CONTACTAayla Jamil, MBBS MPH
PRINCIPAL_INVESTIGATORRobert Gottlieb, MD
BSWRI
Outcome results
None listed