Development of Non-invasive Cell-free DNA to Supplant Invasive Biopsy in Heart Transplantation

NCT05309382 | Completed

• 1 other identifier: 22-062-TRP
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 9

Brief Summary

This is a prospective, multicenter observational, unblinded, longitudinal cohort study. Subjects will be enrolled into the study prior to or at the time of heart transplantation. All subjects will follow the center's standard of care surveillance schedule. Blood samples will be collected for Prospera testing at the time any surveillance or for-cause testing, which may include endomyocardial biopsy (EMB), echocardiography or other cardiac imaging studies, and/or molecular testing, is performed.

Conditions

Heart Transplant

Keywords

Prospera; dd-cfDNA; Heart; Transplant

Outcome Measures

Primary Outcomes (2)

• Primary Molecular Endpoint

  Percent and quantity of donor-derived cell-free DNA (dd-cfDNA) measured via the Prospera test.

  1 year

• Primary clinical endpoint*

  Incidence of the composite endpoint of treated rejection, graft dysfunction, re-transplantation, or death at 12 months after transplant. \*Clinical endpoints are defined as follows: 1. Treated rejection: treated biopsy proven rejection (ISHLT ACR Grade ≥ 2R or AMR Grade ≥ pAMR1) or biopsy-negative rejection treated with pulse-dose steroids, monoclonal antibodies, plasmapheresis and/or intravenous immunoglobulin (IVIg). 2. Graft dysfunction: left ventricular ejection fraction (LVEF) decline \>10% from baseline and \< 50% absolute LVEF by echocardiography. 3. Re-transplantation: being listed for re-transplant or being re-transplanted. 4. Death due to any cause.

  12 months

Secondary Outcomes (1)

• Secondary Endpoints

  12 months

Interventions

Prospera DIAGNOSTIC_TEST

Monthly testing and results provided

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 transplant rejection

You may qualify if:

• 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.
• Able to read, understand, and provide written informed consent.
• Able and willing to comply with the study visit schedule, study procedures, and study requirements.

You may not qualify if:

• Concurrent multiple solid organ or tissue transplants.
• Prior history of any organ or cellular transplantation.
• Pregnant.

Sponsors & Collaborators

• Natera, Inc.: lead

Study Sites (9)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37332, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

Study Officials

• Michael Olymbios, MD

  Natera, Inc.

  STUDY DIRECTOR

• Palak Shah, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

• Josef Stehlik, MD

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: December 12, 2022
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)