Recruiting

Non-Invasive Detection

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07770659

Conditions

Heart Transplant

Pediatric Heart Transplant

Rejection

Cardiac MRI

Cell Free DNA

Eligibility Criteria

Sex: All

Age: 6 - 25

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant. In order to screen for rejection, most centers perform heart catheterizations with endomyocardial biopsies frequently in the first year post transplant and then every 1-2 years thereafter; these biopsies are associated with complications, can cause significant anxiety in patients and family members, and are a significant cost for the healthcare system. This project will evaluate non-invasive methods of detecting rejection using cardiac magnetic resonance imaging and blood testing with a goal to reduce the required number of cardiac catheterizations.

Conditions

Heart Transplant

Pediatric Heart Transplant

Rejection

Cardiac MRI

Cell Free DNA

Study ID

NCT07770659

Start date

Mar 29, 2023

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Received heart transplant at age < 21 years old
  • > 2 months from transplant
  • ≥6 years old and ≤ 25 years old and able to undergo cardiac MRI (CMR)
  • CMR can be scheduled within 5 days from heart biopsy\*
  • Heart catheterization with biopsy is scheduled "for cause" to confirm suspected AR or Heart catheterization with biopsy is scheduled for surveillance

Exclusion Criteria:

  • No endomyocardial biopsy scheduled
  • Other illness or disease process that could potentially lead to myocardial edema or fibrosis
  • Contraindication to CMR with contrast
  • Previously enrolled in this study, UNLESS previous enrollment was heart biopsy scheduled for surveillance with no suspicion of AR AND final study status was documented as "no AR" AND current enrollment is heart biopsy is scheduled "for cause" to confirm suspected AR
  • Multiple transplanted organs
  • Requires anesthesia for CMR

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy pediatric heart transplant recipients

Pediatric heart transplant recipients not having rejection

Pediatric heart transplant recipients with acute rejection

Pediatric heart transplant recipients with acute rejection (ACR or AMR) as defined by the the core pathologist.

Healthy controls

Healthy control patients retrospectively enrolled at each site to standardize parametric mapping.

Primary outcome measure

  • Acute rejection [ Time Frame: time of enrollment ]

Central Contacts and Locations

Central contacts

Jonathan Soslow, MD MSCI

615-322-7447PEACE@vumc.org

Locations

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Study Coordinator

501-364-4000peac@vumc.org

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Study Coordinator

323-361-2461

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Study Coordinator

310-267-7667peace@vumc.org

Lucile Packard Children's Hospital at Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Study Coordinator

650-337-3766peace@vumc.org

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Study Coordinator

858-966-5855peace@vumc.org

Children's Hospital Colorado

Recruiting

Denver, Colorado, United States, 13123

Contacts

Study Coordinator

720-777-6820peace@vumc.org

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Study Coordinator

(352) 273-7770peace@vumc.org

Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Study Coordinator

954-265-3437peace@vumc.org

Children's Hospital of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Study Coordinator

404-256-2593peace@vumc.org

Lurie Children's Hospital

Recruiting

Chicago, Illinois, United States, 02115

Contacts

Study Coordinator

312-227-4000peace@vumc.org

Riley Children's Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Study Coordinator

317-944-8906peace@vumc.org

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Study Coordinator

617-355-6000peace@vumc.org

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Study Coordinator

734-764-5176peace@vumc.org

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Coordinator

314-454-6095peace@vumc.org

Mount Sinai Kravis Children's Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Study Coordinator

212-241-9500peace@vumc.org

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Study Coordinator

212-305-4432peace@vumc.org

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Study Coordinator

614-722-2530peace@vumc.org

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Study Coordinator

peace@vumc.org

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

832-824-3278peace@vumc.org

UT Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-486-6755peace@vumc.org

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Study Coordinator

206-987-2000peace@vumc.org

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Study Coordinator

414-266-6457peace@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Aug 20, 2026

Last verified

Jun, 2026

Keywords

  • Pediatric heart transplant
  • acute rejection
  • acute cellular rejection
  • antibody mediated rejection
  • cardiac mri
  • cell free DNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-08-20.