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NCT Number: NCT04656080

Cardiopulmonary Stress Testing (CPET) AlloSure Study

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor Scott & White health research institute

Dallas, Texas, 75246, United States

Location status: Recruiting

Location contact

Aayla Jamil, MBBS MPH

CONTACT

[email protected]

214-820-1675

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Post-orthotopic heart transplant patients

Exclusion criteria

  • orthopedic, neurologic and/or any other limitations that do not allow for exercise testing on a treadmill or cycle ergometer;
  • individuals who require supplemental oxygen or have current permanent tracheostomies will be excluded from this study;
  • individuals who are discharged to a long-term acute care facility;
  • 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.

Treatment and study plan

CPET exercise testing

Behavioral
  • 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.

Primary outcomes

  1. • Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise

    Time frame: 10 days

    • Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
  2. • Comparison of maximal oxygen consumption (VO2)

    Time frame: 10 days

    • Comparison of maximal oxygen consumption (VO2)
  3. • Comparison of level of cell-free DNA

    Time frame: 10 days

    Comparison of level of cell-free DNA

Secondary outcomes

  1. • Time-dependent changes in high-sensitivity troponin-levels

    Time frame: 10 days

    • Time-dependent changes in high-sensitivity troponin-levels

Study contacts

Contact information is provided by the study sponsor or research team.

Aayla Jamil, MBBS MPH

CONTACT

[email protected]

214-820-1675

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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?

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Dec 7, 2020
Registry last updated
Jan 22, 2026

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.

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