Prospera Test Evaluation in Cardiac Transplant (ProTECT)

NCT05205551 | Active Not Recruiting

• 1 other identifier: 21-054-TRP
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• Primary Endpoints:

  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).

  3 years

Secondary Outcomes (1)

• Secondary Endpoints

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart Transplantation Patients

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Natera, Inc.: lead

Study Sites (1)

Natera

San Carlos, California, 94070, United States

Location

Study Officials

• Michael Olymbios, MD

  Natera, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 25, 2022
• Study Start: October 1, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

US (1)