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Prospera Test for Heart Transplant Rejection (ACES-EMB Trial)

N/A

Recruiting

Research Sponsored by Natera, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older at the time of signing informed consent

Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant

Must not have

Concurrent multiple solid organ or tissue transplants

Prior history of any organ or cellular transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two methods of monitoring heart transplant patients: Prospera surveillance and EMB surveillance. Patients will be randomly assigned to one of these methods after their transplant surgery. Both groups will be monitored

Who is the study for?

This trial is for adults over 18 who can consent, are being evaluated for or on the waiting list for a heart transplant, and willing to follow the study's visit schedule and procedures. It excludes those unable to meet these requirements.

What is being tested?

The study compares two methods of monitoring heart transplant rejection: Prospera™ Test (blood test) versus Endomyocardial Biopsy (tissue sample). Patients will be assigned randomly in a 2:1 ratio favoring Prospera after their transplant.

What are the potential side effects?

While specific side effects are not listed, generally, blood tests like Prospera may cause minor discomfort or bruising at the puncture site; biopsies like EMB can have risks such as bleeding or infection at the biopsy site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am being evaluated for or am on the waiting list for a heart transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had multiple organ or tissue transplants.

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I have had an organ or stem cell transplant in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Clinical Endpoint

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prospera Surveillance CohortExperimental Treatment1 Intervention

Subjects are required to undergo Prospera testing at times corresponding to the institution's graft surveillance schedule. Prospera test results will be provided to the clinical team. Prospera cfDNA level \< 0.15% will be interpreted as low risk for acute rejection (AR). Prospera cfDNA ≥ 0.15% will be interpreted as increased risk for AR and may be followed by EMB to rule out AR at the discretion of the treating clinicians. All other standard of care modalities for assessing AR can be used at the discretion of the treating clinicians at any time throughout the study. As per standard of care, in subjects with clinical signs or symptoms of rejection, a for cause EMB can be done per the clinical team's discretion at any time during the study.

Group II: Endomyocardial Biopsy Surveillance CohortActive Control1 Intervention

Subjects will undergo surveillance EMB per the institution's standard clinical care. Biopsy interpretation will be per the institutional pathologist using international guidelines for grading of acute cellular or antibody-mediated rejection. Subjects will also have Prospera testing performed at the time of surveillance EMB for the purpose of measuring concordance between dd-cfDNA surveillance testing and surveillance EMB; Prospera results will not be returned to investigators for subjects in the EMB surveillance group.

0 / 4Eligibility criteria met