Heart Transplantation - Renewal

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

Qualifiers

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

All ages

Disqualifiers

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

Patients who have not received a heart transplant

Trial design

Treatments tested in this trial

  • MRI Sequencing
  • MRI Testing (pediatric)
  • MRI Testing

Treatment groups

247 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Northwestern University

Lead sponsor

National Institutes of Health (NIH)

Collaborator