Recruiting

AlloSure

Sponsor:

Baylor Research Institute

Code:

NCT04656080

Conditions

Heart Failure

Transplant; Failure, Heart

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CPET exercise testing

Study Details

Brief 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).

Conditions

Heart Failure

Transplant; Failure, Heart

Study ID

NCT04656080

Start date

May 21, 2020

Status verified date

Oct, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

27 participants

Anticipated

Interventions and Outcome Measures

Arms

transplant recipients <1year without AMR

20 recent transplant recipients (<1 year) without antibody-mediated rejection (AMR);

3 months post-heart transplant with AMR

• 7 transplant recipients, at least 3 months post-transplant, with antibody-mediated rejection

Interventions

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.

Primary outcome measure

  • • Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise [ Time Frame: 10 days ]
  • • Comparison of maximal oxygen consumption (VO2) [ Time Frame: 10 days ]
  • • Comparison of level of cell-free DNA [ Time Frame: 10 days ]

Central Contacts and Locations

Central contacts

Aayla Jamil, MBBS MPH

214-820-1675Aayla.Jamil@bswhealth.org

Locations

Baylor Scott & White health research institute

Recruiting

Dallas, Texas, United States, 75246

Contacts

Aayla Jamil, MBBS MPH

214-820-1675Aayla.Jamil@BSWHEALTH.ORG

More Information

Sponsor

Baylor Research Institute

Last update posted

Jan 22, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-01-22.