Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation (DETECT)

Natera

Status: Withdrawn

Conditions: Heart Transplant Failure and Rejection

Treatments: Procedure: Endomyocardial biopsy; Diagnostic Test: Prospera Transplant Assessment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05081739

21-053-TRP

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age 18 years or older at the time of signing informed consent.
2. On the heart transplant waiting list and expected to receive a heart transplant.
3. Able to read, understand and provide written informed consent.
4. Able and willing to comply with the study visit schedule, study procedures and study requirements.

Exclusion criteria

1. Heart transplantation has been performed.
2. Concurrent multiple solid organ or tissue transplant
3. Prior history of any organ or cellular transplantation.
4. Planned use of other commercially available or investigational cfDNA or gene expression profile assays.
5. Pregnant.
6. Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Prospera Surveillance

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Prospera Transplant Assessment

EMB Surveillance

Active Comparator group

Description:

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.

Treatment:

Procedure: Endomyocardial biopsy