Heart Transplant Failure and RejectionDETECTNCT05081739
Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation
A study testing Prospera Transplant Assessment and Endomyocardial biopsy in people with Heart Transplant Failure and Rejection, run by Natera, Inc..
Trial summary
The study objective is to demonstrate that rejection surveillance of heart transplant recipients with Prospera dd-cfDNA is non-inferior to rejection surveillance with endomyocardial biopsy and histology in the first post-transplant year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Failure and Rejection
- What is being tested?
- Prospera Transplant Assessment and Endomyocardial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Male or female, age 18 years or older at the time of signing informed consent.
- On the heart transplant waiting list and expected to receive a heart transplant.
- Able to read, understand and provide written informed consent.
- Able and willing to comply with the study visit schedule, study procedures and study requirements.
Who cannot join
- Heart transplantation has been performed.
- Concurrent multiple solid organ or tissue transplant
- Prior history of any organ or cellular transplantation.
- Planned use of other commercially available or investigational cfDNA or gene expression profile assays.
- Pregnant.
- Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study
About this study
The study objective is to demonstrate that rejection surveillance of heart transplant recipients with Prospera dd-cfDNA is non-inferior to rejection surveillance with endomyocardial biopsy and histology in the first post-transplant year.
Read the detailed description
Subjects will be enrolled into the study while on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. EMB during this phase is expected to occur roughly weekly.
Subjects will be randomized in a 1:1 ratio 30 days (± 7 days) post-transplant to Prospera surveillance (Study Group) versus EMB surveillance (Control Group, standard clinical care). Rejection surveillance (Prospera testing in the Study Group and EMB in the Control Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance.
Study Group: Prospera Surveillance (300 Subjects) Subjects will undergo Prospera testing at times corresponding to the institution's graft surveillance schedule. Prospera test results will be provided to the clinical team. Prospera cfDNA level < 0.15% will be interpreted as negative and a surveillance EMB will be omitted. Prospera cfDNA ≥ 0.15% will be followed by EMB. A for-cause EMB can be done per the clinical team's discretion at any time.
Control Group: EMB Surveillance (standard of care) (300 Subjects) Subjects will undergo surveillance EMB per the institution's standard clinical care.
The study intervention will be during the first 12 months post-transplant.
- Conditions
- Heart Transplant Failure and Rejection
- Being tested
- Prospera Transplant Assessment, Endomyocardial biopsy
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospera Transplant AssessmentDiagnostic test
Prospera™ detects allograft rejection noninvasively and with high accuracy by measuring the fraction of dd-cfDNA in the patient's blood, without the need for prior donor or recipient genotyping.
Prospera is a commercially available LDT developed by Natera, Inc. Natera is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA).
Endomyocardial biopsyProcedure or surgery
Subjects will undergo surveillance EMB per the institution's standard clinical care, which is expected to be approximately every other week in months 2 and 3, then monthly through month 6, then every 1-3 months through the end of month 12.
| Study group | Role | What they receive |
|---|---|---|
| Prospera Surveillance | Experimental | Subjects will undergo Prospera testing in accordance with the institution's Control Group EMB surveillance standard of care schedule, which is expected to be approximately every other week months 2 and 3, then monthly through months 4 through 6, then every 1-3 months during months 7 through 12. Prospera test results will be provided to investigators. Prospera cfDNA level < 0.15 % will be interpreted as negative, and screening EMB will be omitted. EMB will be performed for cfDNA level ≥ 0.15 %. At any time, the clinical team may perform for cause EMB for standard clinical indications (e.g., evidence of graft failure) as per the treating team's discretion. Receives: Diagnostic Test: Prospera Transplant Assessment |
| EMB Surveillance | Active comparator | Subjects will undergo surveillance EMB per the institution's standard clinical care, which is expected to be approximately every other week months 2 and 3, then monthly through months 4 through 6, then every 1-3 months during months 7 through 12. At any time, the clinical team may perform for cause EMB for standard clinical indications (e.g., evidence of graft failure) as per the treating team's discretion. Receives: Procedure: Endomyocardial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the use of Prospera for post-transplant surveillance is non-inferior to the current standard of care, EMB surveillance, with respect to the primary composite endpoint.
The primary endpoint of the study is a composite endpoint defined as the first occurrence of one or more of the following events after transplant:
- Treated rejection with or without graft dysfunction and/or graft dysfunction requiring treatment with pulse dose steroids, monoclonal antibodies, plasmapheresis, and/or intravenous immunoglobulin (IVIg)
- Graft dysfunction
- Re-transplantation
- Death
Clinical endpoints are defined as follows:
- Rejection: ISHLT ACR Grade ≥ 2R or AMR Grade ≥ pAMR1
- Graft dysfunction: LVEF decline >10% from baseline and < 50% absolute LVEF by echocardiography
- Re-transplantation: being listed for re-transplant or being re-transplanted
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study startJan 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Sponsor made decision to pause study while it was still in development phase. The FDA and IRB approval process had not been completed. No sites were activated. No subjects had been recruited for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by Natera, Inc.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Olymbios, MD, Study director, Natera, Inc.Palak Shah, MD, Principal investigator, Inova Health Care ServicesJosef Stehlik, MD, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081739
- Sponsor's protocol ID
- 21-053-TRP
- Acronym
- DETECT
- Status last verified
- Apr 2024
- First submitted
- 17 Sep 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation
- ClinicalTrials.gov ID
- NCT05081739
- Acronym / sponsor ID
- DETECT / 21-053-TRP
- Conditions
- Heart Transplant Failure and Rejection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor made decision to pause study while it was still in development phase. The FDA and IRB approval process had not been completed. No sites were activated. No subjects had been recruited for this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 18 Oct 2021 (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.
The study objective is to demonstrate that rejection surveillance of heart transplant recipients with Prospera dd-cfDNA is non-inferior to rejection surveillance with endomyocardial biopsy and histology in the first post-transplant year.
Detailed description
Subjects will be enrolled into the study while on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. EMB during this phase is expected to occur roughly weekly.
Subjects will be randomized in a 1:1 ratio 30 days (± 7 days) post-transplant to Prospera surveillance (Study Group) versus EMB surveillance (Control Group, standard clinical care). Rejection surveillance (Prospera testing in the Study Group and EMB in the Control Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance.
Study Group: Prospera Surveillance (300 Subjects) Subjects will undergo Prospera testing at times corresponding to the institution's graft surveillance schedule. Prospera test results will be provided to the clinical team. Prospera cfDNA level < 0.15% will be interpreted as negative and a surveillance EMB will be omitted. Prospera cfDNA ≥ 0.15% will be followed by EMB. A for-cause EMB can be done per the clinical team's discretion at any time.
Control Group: EMB Surveillance (standard of care) (300 Subjects) Subjects will undergo surveillance EMB per the institution's standard clinical care.
The study intervention will be during the first 12 months post-transplant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospera Surveillance | Experimental | Diagnostic Test: Prospera Transplant AssessmentSubjects will undergo Prospera testing in accordance with the institution's Control Group EMB surveillance standard of care schedule, which is expected to be approximately every other week months 2 and 3, then monthly through months 4 through 6, then every 1-3 months during months 7 through 12. Prospera test results will be provided to investigators. Prospera cfDNA level < 0.15 % will be interpreted as negative, and screening EMB will be omitted. EMB will be performed for cfDNA level ≥ 0.15 %. At any time, the clinical team may perform for cause EMB for standard clinical indications (e.g., evidence of graft failure) as per the treating team's discretion. |
| EMB Surveillance | Active comparator | Procedure: Endomyocardial biopsySubjects will undergo surveillance EMB per the institution's standard clinical care, which is expected to be approximately every other week months 2 and 3, then monthly through months 4 through 6, then every 1-3 months during months 7 through 12. At any time, the clinical team may perform for cause EMB for standard clinical indications (e.g., evidence of graft failure) as per the treating team's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age 18 years or older at the time of signing informed consent.
- On the heart transplant waiting list and expected to receive a heart transplant.
- Able to read, understand and provide written informed consent.
- Able and willing to comply with the study visit schedule, study procedures and study requirements.
Key exclusion criteria (6 listed)
- Heart transplantation has been performed.
- Concurrent multiple solid organ or tissue transplant
- Prior history of any organ or cellular transplantation.
- Planned use of other commercially available or investigational cfDNA or gene expression profile assays.
- Pregnant.
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 |
|---|---|---|
| Prospera Transplant AssessmentProspera™ detects allograft rejection noninvasively and with high accuracy by measuring the fraction of dd-cfDNA in the patient's blood, without the need for prior donor or recipient genotyping. Prospera is a commercially available LDT developed by Natera, Inc. Natera is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). | Diagnostic test | Prospera Surveillance |
| Endomyocardial biopsySubjects will undergo surveillance EMB per the institution's standard clinical care, which is expected to be approximately every other week in months 2 and 3, then monthly through month 6, then every 1-3 months through the end of month 12. | Procedure or surgery | EMB Surveillance |
Primary outcome
Demonstrate the use of Prospera for post-transplant surveillance is non-inferior to the current standard of care, EMB surveillance, with respect to the primary composite endpoint.
Time frame: 12 months
The primary endpoint of the study is a composite endpoint defined as the first occurrence of one or more of the following events after transplant: 1. Treated rejection with or without graft dysfunction and/or graft dysfunction requiring treatment with pulse dose steroids, monoclonal antibodies, plasmapheresis, and/or intravenous immunoglobulin (IVIg) 2. Graft dysfunction 3. Re-transplantation 4. Death Clinical endpoints are defined as follows: * Rejection: ISHLT ACR Grade ≥ 2R or AMR Grade ≥ pAMR1 * Graft dysfunction: LVEF decline >10% from baseline and < 50% absolute LVEF by echocardiography * Re-transplantation: being listed for re-transplant or being re-transplanted
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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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. This study is not recruiting at the moment.
Michael Olymbios, MD study director
Natera, Inc.
Palak Shah, MD principal investigator
Inova Health Care Services
Josef Stehlik, MD study chair
University of Utah
Questions about this trial
What is this clinical trial studying?
A study testing Prospera Transplant Assessment and Endomyocardial biopsy in people with Heart Transplant Failure and Rejection, run by Natera, Inc..
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the use of Prospera for post-transplant surveillance is non-inferior to the current standard of care, EMB surveillance, with respect to the primary composite endpoint. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2024.