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NCT04656080 · ClinicalTrials.gov registry record
Cardiopulmonary Stress Testing (CPET) AlloSure Study
A clinical trial of Heart Failure and Transplant; Failure, Heart, sponsored by Baylor Research Institute.
- Recruiting
- Registry status
- 27
- Enrollment target
- 1
- Study location
NCT04656080: Recruiting study of Heart Failure and Transplant; Failure, Heart, sponsored by Baylor Research Institute.
NCT04656080 is a study of Heart Failure and Transplant; Failure, Heart that is actively recruiting participants, run by Baylor Research Institute. The registered enrollment target is 27 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04656080, a study of Heart Failure and Transplant; Failure, Heart, is actively recruiting participants, sponsored by Baylor Research Institute.
- RECRUITING
- Registry status
- 27 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
Conditions Studied
Interventions
- BEHAVIORAL CPET exercise testing
Study Locations (1)
Texas
- Baylor Scott & White health research institute - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-05-21 |
| Est. Completion | 2027-12 |
What NCT04656080 shows while recruiting
NCT04656080 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which CPET exercise testing is the first listed.
NCT04656080 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04656080 about?
NCT04656080 is a clinical study titled "Cardiopulmonary Stress Testing (CPET) AlloSure Study". 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 c...
What is the current status of trial NCT04656080?
This trial is currently recruiting. The enrollment target is 27 participants. The study started on 2020-05-21. Estimated completion is 2027-12.
What conditions does trial NCT04656080 study?
This clinical trial studies the following conditions: Heart Failure, Transplant; Failure, Heart.
What interventions are being tested in trial NCT04656080?
The interventions under investigation include: CPET exercise testing (BEHAVIORAL).
Who is sponsoring clinical trial NCT04656080?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04656080 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04656080's enrollment target sits among peer trials
27 330th of 397 higher than 66 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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