RecruitingNCT04656080

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?

Sponsor

Baylor Research Institute

Enrollment

27 participants

Start Date

May 21, 2020

Study Type

OBSERVATIONAL

Conditions

Heart Failure Transplant; Failure, Heart

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study looks at whether a blood test called AlloSure — which detects donor DNA in the blood — can predict heart transplant rejection when combined with a cardiopulmonary exercise test (a supervised stress test). It is not testing a new treatment. **You may be eligible if...** - You have received a heart transplant **You may NOT be eligible if...** - You have orthopedic or neurological problems that prevent you from doing an exercise test on a treadmill or bike - You require supplemental oxygen or have a permanent breathing tube (tracheostomy) - You were discharged to a long-term care or skilled nursing facility - You are receiving palliative or hospice care - You are an inmate or are pregnant - You have antibody-mediated rejection that makes exercise testing unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Baylor Scott & White health research institute

Dallas, Texas, United States

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NCT04656080

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