Non-invasive Prediction of EArly Cardiac rEjection

Conditions

• Cardiac MRI
• Cell Free DNA
• Heart Transplant
• Pediatric Heart Transplant
• Rejection

Eligibility Criteria

Sex

ALL

Age

6 Years - 25 Years

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Aug 18, 2026

Start date

Mar 29, 2023

Status verified

Jun 2026

Primary completion

Feb 1, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

200 participants (estimated)

Arms

• Arm: Healthy pediatric heart transplant recipients
  Pediatric heart transplant recipients not having rejection
• Arm: Pediatric heart transplant recipients with acute rejection
  Pediatric heart transplant recipients with acute rejection (ACR or AMR) as defined by the the core pathologist.
• Arm: 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

• Jonathan Soslow, MD MSCI
  615-322-7447
  [email protected]

Locations (22)

Find similar trials in Little Rock, AR

Related Studies

• Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial
  Enrolling By Invitation · Indiana University · Indianapolis, Indiana
• Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
  Recruiting · University of Florida · Coral Gables, Florida
• US National OCS Heart Perfusion (OHP) Registry
  Recruiting · TransMedics · Phoenix, Arizona
• MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
  Recruiting · University of California, San Francisco · San Francisco, California