Cardiopulmonary Stress Testing (CPET) AlloSure Study

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT04656080
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
May 21, 2020
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
27 participants (estimated)

Arms

  • Arm: transplant recipients <1year without AMR
    20 recent transplant recipients (\<1 year) without antibody-mediated rejection (AMR);
  • Arm: 3 months post-heart transplant with AMR
    • 7 transplant recipients, at least 3 months post-transplant, with antibody-mediated rejection

Primary Outcome Measure

• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise [ Time Frame: 10 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Scott & White health research instituteDallasTexas75246
Aayla Jamil, MBBS MPH
[email protected]
214-820-1675

Find similar trials in Dallas, TX

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Baylor Scott & White health research institute· Dallas, TX

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