Actively Recruiting

All Genders
Healthy Volunteers
NCT05521399

Heart Transplantation - Renewal

Led by Northwestern University · Updated on 2026-03-24

247

Participants Needed

2

Research Sites

427 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Heart transplantation (HTx) is a well-established life-saving procedure but is associated with severe complications. Regular monitoring of heart transplant recipients is thus important for the early detection of these complications. Current standard clinical tests, however, rely on frequent invasive procedures including endomyocardial biopsies (EMB) and catheter angiography (Cath). In addition, these standard tests are limited by sampling error, the diffuse nature of HTx complications, and high health care utilization cost, estimated at \>$150,000 per year per patient in the US. To address these limitations, our group has developed a non-invasive multiparametric cardiac MRI, which can quantify abnormal changes in heart tissue and function. Our efforts during the initial period of this study (NIH funded 2014-2019) have focused on the two major complications of HTx: 1) acute cardiac rejection (ACR), the leading cause of death in the first year after heart transplant; and 2) cardiac allograft vasculopathy (CAV), the greatest risk factor for 5-year mortality beyond the first year after heart transplantation. For these major compilation, our previous cardiac MRI studies have identified new non-invasive cardiac MRI measures that can detect abnormalities of heart tissue and function. In addition, the data was able to show that heart donor and recipient mismatch (age, sex, height, weight, etc.) can cause changes in tissue and function of the transplanted heart.

CONDITIONS

Official Title

Heart Transplantation - Renewal

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age at Northwestern University
  • Able to complete the MR safety screening form as required by standard of care
  • Able to understand and provide informed consent
  • Adult heart transplant patients scanned at CTI with baseline cardiac MRI prior to April 2017
  • Pediatric controls of all ages with no known congenital heart disease receiving clinical cardiac MRI
  • Pediatric heart transplant patients of all ages receiving baseline clinical cardiac MRI
Not Eligible

You will not qualify if you...

  • Abnormal kidney function with eGFR less than 30 mL/min or history of kidney or liver transplant
  • Contraindications to MRI such as device implants or metal hardware as determined by staff technologists
  • Adults unable to provide informed consent
  • Pediatric heart transplant patients who have not received a heart transplant
  • Pediatric patients who have not had baseline cardiac MRI
  • Pediatric patients not receiving the supplemental 10-minute scan due to general anesthesia concerns
  • Patients with MRI scan abnormalities disqualifying them as controls

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Northwestern University- Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Actively Recruiting

2

The Ann & Robert Lurie Children's Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

E

Emily Powell

CONTACT

A

Ayesha Muzaffar

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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