An interventional study of Prospera Transplant Assessment and Endomyocardial biopsy in Heart Transplant Failure and Rejection, sponsored by Natera, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Natera, Inc. · Not applicable, Interventional, and Prevention
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.
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.
Natera, Inc. is the lead sponsor of 36 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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.
Diagnostic Test: Prospera Transplant Assessment
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.
Procedure: Endomyocardial biopsy
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).
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.
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: 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
Time frame: 12 months
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Natera, Inc.