Recruiting

Heart TransplantationHeart Transplantation - Renewal

Sponsor:

Northwestern University

Code:

NCT05521399

Conditions

Transplant, Heart

Magnetic Resonance Imaging

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

MRI Sequencing

MRI Testing (pediatric)

MRI Testing

Study Details

Brief summary:

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

Transplant, Heart

Magnetic Resonance Imaging

Study ID

NCT05521399

Start date

Nov 19, 2021

Status verified date

Mar, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

At Northwestern University:

At least 18 years of age
Able to complete the MR safety screening form as required by SOC
Able to comprehend and provide informed consent

Adult Heart Transplant patients scanned at CTI

-Baseline cardiac MRI prior to 4/2017

Pediatric controls scanned at Lurie

All ages
No known CHD
Receiving clinical cardiac MRI: Some pediatric patients are scheduled to receive cardiac -MRI's to rule out congenital heart disease. In some instances, the outcome is normal - these patients would be considered healthy controls. Pediatric controls are getting MRI scans of heart only.

Pediatric heart transplant patients scanned at Lurie

All ages
Receiving baseline clinical cardiac MRI
Past heart Tx

Exclusion Criteria:

Abnormal kidney function (eGFR < 30 mL/min/). Patients with a history of kidney problems (GFR < 30 ml/min) or have had a kidney and/or liver transplant will be excluded from the study or may undergo the MRI exam without the use of a contrast agent, per standard MR exclusion criteria
Contraindication to MRI i.e. device implants, metal hardware, etc as determined by staff technologists
Adults unable to consent

Pediatric heart transplant patients scanned at Lurie

Patients who have not received a heart transplant
Patients who have not received a cardiac MRI at baseline
Individuals not receiving the supplemental 10-minute scan, due to GA concerns, will be counted towards the desired study population.
If a scan returns with an abnormality, they would no longer be considered control and would not be counted towards the desired study population. It is not until the exam is completed the data may be able to determine whether a patient will qualify as a control. Ordering providers routinely order MRI exams to rule out a certain abnormality. This is similar to ordering providers to request a brain MRI if a patient presents with certain symptoms, such as a headache, to rule out a brain tumor. In many cases those exams may return unremarkable.

Study Design

Enrollment

247 participants

Anticipated

Interventions and Outcome Measures

Arms

Aim#1 Development

Developing dedicated multiparametric cardiac MRI protocols that account for a wide range of body sizes and patient physiology (e.g., heart rates, breathing patterns) of heart transplant recipients, is critical for the wide age range in HTx from pediatric to adult. Second, to facilitate clinical translation and multi-site portability of the often time-consuming data analysis. Methodology, to be employed and developed artificial intelligence (AI) deep learning concepts to enable automated cardiac MRI analysis across large cohorts. The hypothesis to be tested is that automated AI analysis can detect altered cardiac MRI metrics with improved efficiency and reduced inter-rater variability

Aim#2 Cardiac MRI in Pediatric HTx & Donor-Recipient Mismatch

Comprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children. The anticipated enrollment of n=80 (20 per year) pediatric HTx patients (<21 years) in years 2-5 at Lurie Children's Hospital. Inclusion criteria include a clinically indicated routine cardiac MRI for HTx graft surveillance. The hypothesis to be tested is that cardiac MRI measures can inform pediatric donor selection by providing important new data on the impact of donor-recipient mismatch (e.g. age, sex, heart size, etc.) on changes in tissue and function of the transplanted heart.

Aim#3 Longitudinal patient outcome study

The study will research the diagnostic value of cardiac MRI to improve the monitoring of heart transplant recipients for the major complications of acute cardiac rejection (ACR) and cardiac allograft vasculopathy (CAV). The anticipated follow-up enrollment of a total of 80 HTx patients during years 2-5 with a minimum of 5-year follow-up (20 HTx patients/year returning for HTx surveillance, baseline MRI scan was performed during the initial funding period. To clarify, our aim isn't to perfectly match donor-recipient but rather to study the clinical implications of mismatch and to help define the threshold for "too much" mismatch. In other words, today human beings sometimes don't accept a heart if the mismatch will be too great, this is sometimes hard to do and literature is scarce, especially in terms of functional rather than anatomic implications. Our goal is that this study could better inform these decisions.

Interventions

MRI Sequencing

MRI test-retest (select healthy volunteers) for development of MRI sequence.

MRI Testing (pediatric)

Comprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children.

MRI Testing

Cardiac MRI to improve HTx monitoring for ACR and CAV as well as outcome prediction

Primary outcome measure

Number and severity of acute rejection (ACR) episodes at follow up, quantified by ACR grade (1R, 2R, 3R) [ Time Frame: 4 years ]
Severity of cardiac allograft vasculopathy (CAV) at follow-up, quantified by CAV grade (0,1,2,3) [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Emily Powell

3126952956 emily.powell@northwestern.edu

Ayesha Muzaffar

312-926-4251 ayesha.muzaffar@northwestern.edu

Locations

Northwestern University- Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Emily Powell

312-695-2956 emily.powell@northwestern.edu

Principal Investigator:

Michael Markl, PhD

The Ann & Robert Lurie Children's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Pooja Narayan, MS

pnarayan@luriechildrens.org

Principal Investigator:

Cynthia K Rugsby, MD

More Information

Sponsor

Northwestern University

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-03-24.