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Simple workout may boost transplant rejection blood test

NCT ID NCT04656080

Knowledge-focused Sponsor: Baylor Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether doing a hard exercise test before a blood draw can make the AlloSure test better at spotting heart transplant rejection. Researchers will test 27 heart transplant recipients, both with stable transplants and those showing signs of rejection. The goal is to see if exercise changes the levels of donor DNA in the blood, which could help doctors catch rejection earlier and more accurately.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that a simple exercise test before a blood draw makes rejection detection more accurate, possibly reducing the need for invasive biopsies.
What could go wrong
This is a very small, early-stage study with only 27 participants. It is designed to gather knowledge, not to prove a new treatment works. Results may not apply to all heart transplant patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 27 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Transplant, failure, heart

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor Scott & White health research institute

    RECRUITING

    Dallas, Texas, 75246, United States

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