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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?

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether exercise changes AlloSure blood test results in people who have had a heart transplant. AlloSure measures tiny pieces of DNA from the donated heart. The study also looks at whether testing after exercise helps find signs that the immune system is attacking the donated heart.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had a heart transplant.

Who can't join

  • Have bone, joint, nerve, or other problems that prevent exercise testing on a treadmill or exercise bike.
  • Need extra oxygen or have a permanent opening in the neck to help with breathing.
  • Are discharged to a long-term hospital care center or skilled nursing facility.
  • Receive palliative care or hospice care.
  • Are in prison.
  • Are pregnant.
  • Have heart rejection caused by antibodies (immune system proteins) and are not considered safe to do a heart and lung exercise test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

TX