Heart Transplantation - Renewal

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05521399
Status
Recruiting
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Conditions

  • Magnetic Resonance Imaging
  • Transplant, Heart

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • MRI Sequencing — DIAGNOSTIC_TEST
    MRI test-retest (select healthy volunteers) for development of MRI sequence.
  • MRI Testing (pediatric) — DIAGNOSTIC_TEST
    Comprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children.
  • MRI Testing — DIAGNOSTIC_TEST
    Cardiac MRI to improve HTx monitoring for ACR and CAV as well as outcome prediction

Study Details

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.

Key Dates

Start date
Nov 19, 2021
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Jan 31, 2030

Study Design

Enrollment
247 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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.
  • Arm: 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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern University- Feinberg School of MedicineChicagoIllinois60611
Emily Powell
[email protected]
312-695-2956
Michael Markl, PhD (PRINCIPAL_INVESTIGATOR)
The Ann & Robert Lurie Children's HospitalChicagoIllinois60611
Pooja Narayan, MS
[email protected]
Cynthia K Rugsby, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University- Feinberg School of Medicine· Chicago, ILThe Ann & Robert Lurie Children's Hospital· Chicago, IL

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