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NCT05205551 · ClinicalTrials.gov registry record
Prospera Test Evaluation in Cardiac Transplant (ProTECT)
A clinical trial of Heart Transplant Rejection, sponsored by Natera.
- Active
- Registry status
- 411
- Enrollment target
- 1
- Study location
NCT05205551: Active study of Heart Transplant Rejection, sponsored by Natera.
NCT05205551 is a study of Heart Transplant Rejection that is active but no longer recruiting, run by Natera. The registered enrollment target is 411 participants, below the 659-participant average among 5 other Heart Transplant Rejection trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05205551, a study of Heart Transplant Rejection, is active but no longer recruiting, sponsored by Natera.
- ACTIVE NOT RECRUITING
- Registry status
- 411 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 ther
Conditions Studied
Study Locations (1)
California
- Natera - San Carlos
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 411 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2027-06-30 |
What the registry record for NCT05205551 still lists
NCT05205551 is an observational study that tracks outcomes without assigning an intervention. The registered 411 participants enrollment target is mid-sized for trials with a published cap, below the 659-participant average among 5 other Heart Transplant Rejection trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Heart Transplant Rejection appearing as the primary indexed condition, and to 0 interventions.
NCT05205551 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05205551 about?
NCT05205551 is a clinical study titled "Prospera Test Evaluation in Cardiac Transplant (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.
What is the current status of trial NCT05205551?
This trial is currently active not recruiting. The enrollment target is 411 participants. The study started on 2021-10-01. Estimated completion is 2027-06-30.
What conditions does trial NCT05205551 study?
This clinical trial studies the following conditions: Heart Transplant Rejection.
Who is sponsoring clinical trial NCT05205551?
This trial is sponsored by Natera, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05205551 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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