Cardiopulmonary Stress Testing (CPET) AlloSure Study

RECRUITING

I'm interested ...!!

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 Start (Actual) 21 May 2020

🗓️ Primary Completion (Estimated) December 2023

✅ Study Completion (Estimated) December 2023

👥 Enrollment (Estimated) 27

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Dallas, Texas, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 6 October 2020
First Submitted that Met QC Criteria 30 November 2020
First Posted 7 December 2020

Study Record Updates

Last Update Submitted that Met QC Criteria 25 January 2023
Last Update Posted 26 January 2023
Last Verified January 2023