Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT06414603
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2024-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012059', 'term': 'Rejection, Psychology'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Clinical Endpoint', 'timeFrame': '12 months', 'description': 'Incidence of the composite endpoint defined as the first occurrence of treated rejection with graft dysfunction\\*, treated rejection without graft dysfunction, graft dysfunction, retransplantation, and/or death.\n\nClinical endpoints are defined as follows:\n\n1. Rejection: ISHLT ACR Grade ≥ 2R or AMR Grade ≥ pAMR1\n2. Graft dysfunction: LVEF decline ≥ 10% from baseline and \\< 50% absolute LVEF by echocardiography\n3. Retransplantation: being listed for re-transplant or being re-transplanted\n\n * Treated rejection with graft dysfunction and/or graft dysfunction requiring treatment with pulse dose steroids, monoclonal antibodies, plasmapheresis, and/or intravenous immunoglobulin (IVIg).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Transplant'], 'conditions': ['Heart Transplant Failure and Rejection']}, 'descriptionModule': {'briefSummary': "This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site.\n\nSubjects will be enrolled into the study while under evaluation for heart transplantation or 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 or bi-weekly.\n\nStudy group assignment will take place at randomization. Subjects will be randomized 30 days (± 10 days) post-transplant to Prospera surveillance versus EMB surveillance in a 2:1 ratio. Rejection surveillance (Prospera Group and EMB Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance.", 'detailedDescription': "All subjects will undergo standard of care assessments for rejection monitoring in addition to Prospera testing and/or EMB in accordance with each site's clinical care protocols and at the discretion of the treating clinician. Quality of life questionnaires will be completed at week 4, month 6 and month 12 post-transplant.\n\nStudy Group: Prospera (dd-cfDNA) Surveillance Group Subjects are required to 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 low risk for acute rejection (AR). Prospera cfDNA ≥ 0.15% will be interpreted as increased risk for AR and may be followed by EMB to rule out AR at the discretion of the treating clinicians. All other standard of care modalities for assessing AR can be used at the discretion of the treating clinicians at any time throughout the study. As per standard of care, in subjects with clinical signs or symptoms of rejection, a for cause EMB can be done per the clinical team's discretion at any time during the study.\n\nControl Group: EMB Surveillance Group Subjects will undergo surveillance EMB per the institution's standard clinical care. Biopsy interpretation will be per the institutional pathologist using international guidelines for grading of acute cellular or antibody-mediated rejection. Subjects will also have Prospera testing performed at the time of surveillance EMB for the purpose of measuring concordance between dd-cfDNA surveillance testing and surveillance EMB; Prospera results will not be returned to investigators for subjects in the EMB surveillance group.\n\nSubjects in both the Prospera and EMB Surveillance Groups will have Prospera blood draws performed at the time of any for cause EMB. Results of Prospera testing performed in conjunction with for cause EMB will not be returned to investigators or subjects.\n\nBlood samples for exploratory mechanistic endpoints (miRNA) will be obtained at the time of each Prospera or EMB surveillance visit and at the time of any for cause EMB.\n\nThe study period will be during the first 12 months post-transplant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 years or older at the time of signing informed consent.\n2. Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant.\n3. Able to read, understand and provide written informed consent. If the patient is unable to sign informed consent, a legally authorized representative (LAR) can consent on behalf of the patient.\n4. Able and willing to comply with the study visit schedule, study procedures and study requirements.\n\nExclusion Criteria:\n\n1. Concurrent multiple solid organ or tissue transplants.\n2. Prior history of any organ or cellular transplantation.\n3. Planned use of other commercially available or investigational cfDNA or gene expression profile assays for rejection surveillance.\n4. Pregnant.\n5. Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT06414603', 'acronym': 'ACES-EMB', 'briefTitle': 'A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Natera, Inc.'}, 'officialTitle': 'A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy (ACES-EMB)', 'orgStudyIdInfo': {'id': '23-069-TRP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospera Surveillance Cohort', 'description': "Subjects are required to 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 low risk for acute rejection (AR). Prospera cfDNA ≥ 0.15% will be interpreted as increased risk for AR and may be followed by EMB to rule out AR at the discretion of the treating clinicians. All other standard of care modalities for assessing AR can be used at the discretion of the treating clinicians at any time throughout the study.\n\nAs per standard of care, in subjects with clinical signs or symptoms of rejection, a for cause EMB can be done per the clinical team's discretion at any time during the study.", 'interventionNames': ['Diagnostic Test: The Prospera™ Test']}, {'type': 'NO_INTERVENTION', 'label': 'Endomyocardial Biopsy Surveillance Cohort', 'description': "Subjects will undergo surveillance EMB per the institution's standard clinical care. Biopsy interpretation will be per the institutional pathologist using international guidelines for grading of acute cellular or antibody-mediated rejection.\n\nSubjects will also have Prospera testing performed at the time of surveillance EMB for the purpose of measuring concordance between dd-cfDNA surveillance testing and surveillance EMB; Prospera results will not be returned to investigators for subjects in the EMB surveillance group."}], 'interventions': [{'name': 'The Prospera™ Test', 'type': 'DIAGNOSTIC_TEST', 'description': "The Prospera™ test is a non-invasive test intended to detect and quantify the fraction of donor-derived cell-free DNA (dd-cfDNA) to supplement management and surveillance of allograft rejection in patients who have undergone organ transplantation. It employs Next Generation Sequencing (NGS), which is performed on cell-free DNA (cfDNA) that is extracted from the patient's plasma to discriminate between the patient's DNA and the solid organ-allograft DNA.\n\nIn study 23-069-TRP, the Prospera test is indicated for heart allograft rejection surveillance in lieu of surveillance endomyocardial biopsy. Prospera results should be considered together with clinical evaluations and other diagnostic testing or imaging results. Prospera will be run as a centralized laboratory developed test that is developed and validated under Design Controls. The test will be run within Natera's CLIA-certified and CAP-accredited laboratory.", 'armGroupLabels': ['Prospera Surveillance Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lucy Garcia', 'role': 'CONTACT', 'email': 'Lucilla.Garcia@csmns.org'}, {'name': 'Evan Kransdorf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Taylor Tran', 'role': 'CONTACT', 'email': 'tyt006@health.ucsd.edu'}, {'name': 'Paul Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Peters', 'role': 'CONTACT', 'email': 'LAURA.PETERS@cuanschutz.edu'}, {'name': 'Amrut Ambardekar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Toukmehji', 'role': 'CONTACT', 'email': 'Toukmehji.Jessica@mayo.edu'}, {'name': 'Jose Nativi-Nicolau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caryn Bernstein', 'role': 'CONTACT', 'email': 'caryn.bernstein@piedmont.org'}, {'name': 'Robert Cole, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Piedmont Healthcare', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Ren', 'role': 'CONTACT', 'email': 'tren2@bwh.harvard.edu'}, {'name': 'Michael Givertz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Schaffer', 'role': 'CONTACT', 'email': 'shaffeke@med.umich.edu'}, {'name': 'Monica Colvin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lacey Taylor', 'role': 'CONTACT', 'email': 'lacey.taylor@duke.edu'}, {'name': 'Adam DeVore, MD', 'role': 'CONTACT'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Browning', 'role': 'CONTACT', 'email': 'Amy.Browning@utsouthwestern.edu'}, {'name': 'Maryjane Farr, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas, Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Habeeb Mohammed', 'role': 'CONTACT', 'email': 'habeeb.mohammad@hsc.utah.edu'}, {'name': 'Kevin Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bhruga Shah', 'role': 'CONTACT', 'email': 'Bhruga.Shah@inova.org'}, {'name': 'Jamie Kennedy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inova Schar Heart and Vascular Institute', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}], 'centralContacts': [{'name': 'Kiara Stoddard', 'role': 'CONTACT', 'email': 'ACES@natera.com', 'phone': '(650) 249-9090'}], 'overallOfficials': [{'name': 'Michael Olymbios, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Natera, Inc.'}, {'name': 'Josef Stehlik, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Utah'}, {'name': 'Palak Shah, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inova Schar Heart and Vascular'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Natera, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}