Heart FailureNCT04656080
Cardiopulmonary Stress Testing (CPET) AlloSure Study
An observational study of Heart Failure and Transplant; Failure, Heart, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Transplant; Failure, Heart
- What is being tested?
- CPET exercise testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2020to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Post-orthotopic heart transplant patients
Who cannot join
- 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;
- patients with antibody-mediate rejection that are not felt to be safe for cardiopulmonary stress testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor Scott & White health research institute
Dallas, Texas, 75246
Aayla Jamil, MBBS MPH, 214-820-1675, Aayla.Jamil@BSWHEALTH.ORG
About this study
Official title: AlloSure Test Characteristics in Immunologically Quiescent and Immunologically Active Heart Transplant Recipients: Does Maximal Cardiopulmonary Stress Testing Prior to Assay Preserve Test Specificity While Enhancing Sensitivity?
- 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).
- 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).
Read the detailed description
The specific research questioned aimed to be addressed with this proposed study are:
- Are dd-cfDNA levels in heart transplant recipients independent of recent cardiopulmonary exercise? More specifically, does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfDNA (if so, then what is the time course for resolution back to baseline?) ii. If dd-cfDNA does not release to any significant degree with cardiac allografts with short donor-ischemic time, does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times? iii. In cardiac transplant recipients with medically stabilized, treated antibody-mediated rejection (AMR) and persistent dd-cfDNA elevation, does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfDNA, and again, with what time course?
- Conditions
- Heart Failure, Transplant; Failure, Heart
- Being tested
- CPET exercise testing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPET exercise testingBehavioural
- 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 group | Role | What they receive |
|---|---|---|
| transplant recipients <1year without AMR | 20 recent transplant recipients (<1 year) without antibody-mediated rejection (AMR); Receives: Behavioral: CPET exercise testing | |
| 3 months post-heart transplant with AMR | • 7 transplant recipients, at least 3 months post-transplant, with antibody-mediated rejection Receives: Behavioral: CPET exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
- Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
Measured: 10 days
• Comparison of maximal oxygen consumption (VO2)
- Comparison of maximal oxygen consumption (VO2)
Measured: 10 days
• Comparison of level of cell-free DNA
Comparison of level of cell-free DNA
Measured: 10 days
Secondary outcomes (1)
• Time-dependent changes in high-sensitivity troponin-levels
- Time-dependent changes in high-sensitivity troponin-levels
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start21 May 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Gottlieb, MD, Principal investigator, BSWRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656080
- Sponsor's protocol ID
- 020-188
- Status last verified
- Oct 2025
- First submitted
- 6 Oct 2020
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26771485
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AlloSure Test Characteristics in Immunologically Quiescent and Immunologically Active Heart Transplant Recipients: Does Maximal Cardiopulmonary Stress Testing Prior to Assay Preserve Test Specificity While Enhancing Sensitivity?
- ClinicalTrials.gov ID
- NCT04656080
- Acronym / sponsor ID
- 020-188
- Conditions
- Heart Failure, Transplant; Failure, Heart
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
- 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).
Detailed description
The specific research questioned aimed to be addressed with this proposed study are:
- Are dd-cfDNA levels in heart transplant recipients independent of recent cardiopulmonary exercise? More specifically, does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfDNA (if so, then what is the time course for resolution back to baseline?) ii. If dd-cfDNA does not release to any significant degree with cardiac allografts with short donor-ischemic time, does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times? iii. In cardiac transplant recipients with medically stabilized, treated antibody-mediated rejection (AMR) and persistent dd-cfDNA elevation, does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfDNA, and again, with what time course?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transplant recipients <1year without AMR | – | Behavioral: CPET exercise testing20 recent transplant recipients (<1 year) without antibody-mediated rejection (AMR); |
| 3 months post-heart transplant with AMR | – | Behavioral: CPET exercise testing• 7 transplant recipients, at least 3 months post-transplant, with antibody-mediated rejection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Post-orthotopic heart transplant patients
Key exclusion criteria (5 listed)
- 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;
- patients with antibody-mediate rejection that are not felt to be safe for cardiopulmonary stress testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPET exercise testing* 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. | Behavioural | 3 months post-heart transplant with AMR, transplant recipients <1year without AMR |
Primary outcome
• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
Time frame: 10 days
• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
• Comparison of maximal oxygen consumption (VO2)
Time frame: 10 days
• Comparison of maximal oxygen consumption (VO2)
• Comparison of level of cell-free DNA
Time frame: 10 days
Comparison of level of cell-free DNA
1 secondary outcome
• Time-dependent changes in high-sensitivity troponin-levels
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 26771485Snyder 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Gottlieb, MD principal investigator
BSWRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Transplant; Failure, Heart, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aayla Jamil, MBBS MPH (214-820-1675, Aayla.Jamil@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04656080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.