Heart Transplant RejectionProTECTNCT05205551
Prospera Test Evaluation in Cardiac Transplant (ProTECT)
An observational study of Heart Transplant Rejection, run by Natera, Inc. at 1 site in United States.
Trial summary
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Rejection
- How many people
- 411 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 30 Jun 2027
- How long will I take part?
- 3 Years
- 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: Heart Transplantation Patients
Patients must meet all the following criteria to be eligible for the study:
- Age 18 or older at the time of informed consent.
- Enrolled within 60 days following heart transplantation.
- Prospera™ testing is planned as part of standard clinical care to monitor for and assess transplant rejection.
- Prospera™ testing is planned to be performed within 60 days (inclusive) following heart transplantation.
- Selected by their healthcare provider to receive or continue receiving Prospera™ testing as part of their routine transplant management.
- Willing and able to provide written informed consent.
- Willing and able to comply with study procedures.
Patients are not eligible for the study if they meet any of the following criteria:
- Pregnant at the time of signing informed consent.
- Candidate for multiple solid organ or tissue transplant.
- History of prior organ or cellular transplantation.
- Ongoing testing with another allograft dd-cfDNA assessment is planned.
Trial locations and contacts
1 site in 1 country.
About this study
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation.
Read the detailed description
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera™ testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation. Patients who are enrolled in this study should have blood drawn for Prospera™ testing at regular intervals per routine clinical care. Prospera™ test results and results of surveillance endomyocardial biopsies, laboratory testing, echocardiograms, angiography and hemodynamic monitoring performed to monitor cardiac status and for signs of transplant rejection, as well as medications and post-transplant re-vascularization and surgical procedures will be recorded in the electronic case report form (eCRF). Patient management decisions, even those informed by the Prospera™ test result, are made based on the individual judgment of the healthcare providers participating in the study.
- Conditions
- Heart Transplant Rejection
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints:
Primary molecular endpoint: percent of donor-derived cell-free DNA (dd-cfDNA) measured via the Prospera™ test.
Primary clinical endpoints:
- Biopsy-proven rejection (ISHLT Grade ACR >1R and ISHLT Grade AMR >0).
- Rejection with hemodynamic compromise (ejection fraction <40% or >20% decline from baseline or the need for inotropic agents in the absence of biopsy-proven rejection).
- Treated rejection (biopsy proven rejection or hemodynamic compromise rejection where immunosuppressive therapy was increased or augmented).
Measured: 3 years
Secondary outcomes (1)
Secondary Endpoints
The secondary endpoints are:
- The predictive performance of the Prospera™ test in detecting rejection or allograft dysfunction after heart transplant as measured by the sensitivity, specificity, negative predictive value, positive predictive value, and area under the curve (AUC) of the Prospera™ test
- Acute cellular rejection (ISHLT 2004 grade >1R)
- Antibody mediated rejection (ISHLT 2013 grade >0)
- Left ventricular ejection fraction (LVEF) measured by echocardiographic assessment
- Cardiac allograft vasculopathy (ISHLT grade >0)
- Cumulative mean fluorescence intensity (MFI) of donor specific antibodies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Oct 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant RejectionStudies 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
- 411 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Olymbios, MD, Principal investigator, Natera, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205551
- Sponsor's protocol ID
- 21-054-TRP
- Acronym
- ProTECT
- Status last verified
- May 2025
- First submitted
- 11 Jan 2022
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospera Test Evaluation in Cardiac Transplant (ProTECT)
- ClinicalTrials.gov ID
- NCT05205551
- Acronym / sponsor ID
- ProTECT / 21-054-TRP
- Conditions
- Heart Transplant Rejection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Jan 2022 (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 ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation.
Detailed description
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera™ testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation. Patients who are enrolled in this study should have blood drawn for Prospera™ testing at regular intervals per routine clinical care. Prospera™ test results and results of surveillance endomyocardial biopsies, laboratory testing, echocardiograms, angiography and hemodynamic monitoring performed to monitor cardiac status and for signs of transplant rejection, as well as medications and post-transplant re-vascularization and surgical procedures will be recorded in the electronic case report form (eCRF). Patient management decisions, even those informed by the Prospera™ test result, are made based on the individual judgment of the healthcare providers participating in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Transplantation Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Endpoints:
Time frame: 3 years
Primary molecular endpoint: percent of donor-derived cell-free DNA (dd-cfDNA) measured via the Prospera™ test. Primary clinical endpoints: 1. Biopsy-proven rejection (ISHLT Grade ACR >1R and ISHLT Grade AMR >0). 2. Rejection with hemodynamic compromise (ejection fraction <40% or >20% decline from baseline or the need for inotropic agents in the absence of biopsy-proven rejection). 3. Treated rejection (biopsy proven rejection or hemodynamic compromise rejection where immunosuppressive therapy was increased or augmented).
1 secondary outcome
Secondary Endpoints
Time frame: 3 years
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 May 2025.
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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 principal investigator
Natera, Inc.
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 Transplant Rejection, run by Natera, Inc. 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?
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: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. 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?
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?
Primary Endpoints: (time frame: 3 years). 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 22 May 2025; AzTrials last refreshed its copy on 1 Nov 2026.