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Heart Transplantation - Renewal

NCT05521399 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 247

Last updated 2026-03-24

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

MRI Sequencing

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

DIAGNOSTIC_TEST

MRI Testing (pediatric)

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

DIAGNOSTIC_TEST

MRI Testing

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

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-19
Primary Completion
2027-04-30
Completion
2030-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05521399 on ClinicalTrials.gov