Prospera Test Evaluation in Cardiac Transplant (ProTECT) (ProTECT)

The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Transplant Rejection

Detailed Description

The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera™ testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation. Patients who are enrolled in this study should have blood drawn for Prospera™ testing at regular intervals per routine clinical care. Prospera™ test results and results of surveillance endomyocardial biopsies, laboratory testing, echocardiograms, angiography and hemodynamic monitoring performed to monitor cardiac status and for signs of transplant rejection, as well as medications and post-transplant re-vascularization and surgical procedures will be recorded in the electronic case report form (eCRF). Patient management decisions, even those informed by the Prospera™ test result, are made based on the individual judgment of the healthcare providers participating in the study.

• Study Type: Observational
• Enrollment (Actual): 411

Contacts and Locations

Study Locations

• United States
  • California
    • San Carlos, California, United States, 94070
      • Natera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Heart Transplantation Patients

Description

Patients must meet all the following criteria to be eligible for the study:

1. Age 18 or older at the time of informed consent.
2. Enrolled within 60 days following heart transplantation.
3. Prospera™ testing is planned as part of standard clinical care to monitor for and assess transplant rejection.
4. Prospera™ testing is planned to be performed within 60 days (inclusive) following heart transplantation.
5. Selected by their healthcare provider to receive or continue receiving Prospera™ testing as part of their routine transplant management.
6. Willing and able to provide written informed consent.
7. Willing and able to comply with study procedures.

Patients are not eligible for the study if they meet any of the following criteria:

1. Pregnant at the time of signing informed consent.
2. Candidate for multiple solid organ or tissue transplant.
3. History of prior organ or cellular transplantation.
4. Ongoing testing with another allograft dd-cfDNA assessment is planned.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoints:	Primary molecular endpoint: percent of donor-derived cell-free DNA (dd-cfDNA) measured via the Prospera™ test. Primary clinical endpoints: Biopsy-proven rejection (ISHLT Grade ACR >1R and ISHLT Grade AMR >0).; Rejection with hemodynamic compromise (ejection fraction <40% or >20% decline from baseline or the need for inotropic agents in the absence of biopsy-proven rejection).; Treated rejection (biopsy proven rejection or hemodynamic compromise rejection where immunosuppressive therapy was increased or augmented).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoints	The secondary endpoints are: The predictive performance of the Prospera™ test in detecting rejection or allograft dysfunction after heart transplant as measured by the sensitivity, specificity, negative predictive value, positive predictive value, and area under the curve (AUC) of the Prospera™ test; Acute cellular rejection (ISHLT 2004 grade >1R); Antibody mediated rejection (ISHLT 2013 grade >0); Left ventricular ejection fraction (LVEF) measured by echocardiographic assessment; Cardiac allograft vasculopathy (ISHLT grade >0); Cumulative mean fluorescence intensity (MFI) of donor specific antibodies	3 years

Collaborators and Investigators

• Sponsor: Natera, Inc.
• Investigators: Principal Investigator: Michael Olymbios, MD, Natera, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 21-054-TRP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No