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

NCT05081739 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-04-03

No results posted yet for this study

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.

Conditions

  • Heart Transplant Failure and Rejection

Interventions

DIAGNOSTIC_TEST

Prospera Transplant Assessment

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).

PROCEDURE

Endomyocardial biopsy

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.

Sponsors & Collaborators

  • Natera, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Olymbios, MD · Natera, Inc.

  • Palak Shah, MD · Inova Health Care Services

  • Josef Stehlik, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-01-31
Completion
2026-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081739 on ClinicalTrials.gov