Prospera Test Evaluation in Cardiac Transplant (ProTECT)

Active, not recruiting

• Conditions: Heart Transplant Rejection

• Registration Number: NCT05205551
• Lead Sponsor: Natera, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-10-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 411

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoints:	3 years	Primary molecular endpoint: percent of donor-derived cell-free DNA (dd-cfDNA) measured via the Prospera™ test.; Primary clinical endpoints: 1. Biopsy-proven rejection (ISHLT Grade ACR \>1R and ISHLT Grade AMR \>0).; 2. 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).; 3. Treated rejection (biopsy proven rejection or hemodynamic compromise rejection where immunosuppressive therapy was increased or augmented).

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints	3 years	The secondary endpoints are: 1. 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; 2. Acute cellular rejection (ISHLT 2004 grade \>1R); 3. Antibody mediated rejection (ISHLT 2013 grade \>0); 4. Left ventricular ejection fraction (LVEF) measured by echocardiographic assessment; 5. Cardiac allograft vasculopathy (ISHLT grade \>0); 6. Cumulative mean fluorescence intensity (MFI) of donor specific antibodies

Trial Locations

Locations (1)

Natera; 🇺🇸 San Carlos, California, United States