NCT04656080

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?

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 27 (estimated)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Heart Failure
• Transplant; Failure, Heart

Interventions

Type	Name	Description
BEHAVIORAL	CPET 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.

Timeline

• Start date: 2020-05-21
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2020-12-07
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States