Cardiopulmonary Stress Testing (CPET) AlloSure Study

NCT04656080 | Recruiting

• 1 other identifier: 020-188
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Outcome Measures

Primary Outcomes (3)

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

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

  10 days

• • Comparison of maximal oxygen consumption (VO2)

  • Comparison of maximal oxygen consumption (VO2)

  10 days

• • Comparison of level of cell-free DNA

  Comparison of level of cell-free DNA

  10 days

Secondary Outcomes (1)

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

  10 days

Study Arms (2)

transplant recipients <1year without AMR

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

Behavioral: CPET exercise testing

3 months post-heart transplant with AMR

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

Behavioral: CPET exercise testing

Interventions

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.

3 months post-heart transplant with AMR; transplant recipients <1year without AMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Post-orthotopic heart transplant patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White health research institute

Dallas, Texas, 75246, United States

RECRUITING

Related Publications (1)

• Snyder MW, Kircher M, Hill AJ, Daza RM, Shendure J. Cell-free DNA Comprises an In Vivo Nucleosome Footprint that Informs Its Tissues-Of-Origin. Cell. 2016 Jan 14;164(1-2):57-68. doi: 10.1016/j.cell.2015.11.050.

  PMID: 26771485 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Robert Gottlieb, MD

  BSWRI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aayla Jamil, MBBS MPH

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: December 7, 2020
• Study Start: May 21, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-10

Locations

US (1)