Baylor Scott & White health research institute
Dallas, Texas, 75246, United States
Location status: Recruiting
NCT Number: NCT04656080
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Dallas, Texas, 75246, United States
Location status: Recruiting
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?
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Post-orthotopic heart transplant patients
Exclusion criteria
(f) patients with antibody-mediate rejection that are not felt to be safe for cardiopulmonary stress testing.
Time frame: 10 days
Time frame: 10 days
Time frame: 10 days
Comparison of level of cell-free DNA
Time frame: 10 days
Contact information is provided by the study sponsor or research team.
Baylor Research Institute
Other
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?
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06895070
Cardiovascular Diseases, Heart Diseases
La Jolla, California, United States
View Trial DetailsNCT03575910
Behavior, Cardiovascular Diseases
Omaha, Nebraska, United States
View Trial DetailsNCT05881278
Cardiovascular Diseases, Heart Diseases
La Jolla, California, United States
View Trial DetailsNCT05610787
Cardiovascular Abnormalities, Cardiovascular Diseases
Los Angeles, California, United States
View Trial Details