Clinical trial NCT05081739: Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation
Official title: Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Transplant Failure and Rejection
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Natera, Inc.
name: Michael Olymbios, MD
role: STUDY_DIRECTOR
affiliation: Inova Health Care Services
name: Palak Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Josef Stehlik, MD
role: STUDY_CHAIR
References: