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Cardiopulmonary Stress Testing (CPET) AlloSure Study

ConditionsHeart FailureTransplant; Failure, Heart
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBaylor Research Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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;

Trial population

The subjects to be enrolled in this study will be male and/or female hemodynamically stable outpatients who have undergone orthotopic heart transplant within three months from enrollment date for the recent transplant cohort, and within 10 years of transplant for the antibody-mediated rejection cohort. All subjects will be 18 to 80 years of age. All subjects must be able to read and understand an informed consent to be enrolled in the study. For the stabilized antibody-mediated rejection cohort, only patients with invasive coronary angiography indicating no more than ISHLT grade 1 coronary allograft vasculopathy within 6 months prior to testing will be included.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: transplant recipients <1year without AMR1 intervention
Group B: 3 months post-heart transplant with AMR1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
10 days
2

• Comparison of maximal oxygen consumption (VO2)

• Comparison of maximal oxygen consumption (VO2)

Time frame
10 days
3

• Comparison of level of cell-free DNA

Comparison of level of cell-free DNA

Time frame
10 days

Secondary outcomes

1

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

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

Time frame
10 days

Other outcomes

Sponsors and contacts

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Baylor Research Institute

Lead sponsor

Source ClinicalTrials.gov
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