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
This trial accepts healthy volunteersQualifiers
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 population
The study population includes pediatric and non-pediatric healthy volunteers; as well as, non-pediatric and pediatric heart transplant patients.
Trial design
Cohort
Prospective
Treatments tested in this trial
MRI Sequencing
Diagnostic testMRI test-retest (select healthy volunteers) for development of MRI sequence.
MRI Testing (pediatric)
Diagnostic testComprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children.
MRI Testing
Diagnostic testCardiac MRI to improve HTx monitoring for ACR and CAV as well as outcome prediction
Treatment groups
Trial outcomes
Primary outcomes
Number and severity of acute rejection (ACR) episodes at follow up, quantified by ACR grade (1R, 2R, 3R)
Long-term Follow-Up (\> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV, and RV volumes, cardiac strain, myocardial fibrosis) for graft complications as defined by the number of acute rejection (ACR) episodes, ACR grade (1R, 2R, 3R)
Severity of cardiac allograft vasculopathy (CAV) at follow-up, quantified by CAV grade (0,1,2,3)
Long-term Follow-Up (\> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV, and RV volumes, cardiac strain, myocardial fibrosis) for graft complications as defined by ardiac allograft vasculopathy (CAV) grade (0,1,2)
Secondary outcomes
Adverse outcome at follow-up, defined by hospitalization (yes/no), nonfatal myocardial infarction (yes/no), coronary revascularization (yes/no), re-transplantation (yes/no), death (yes/no)
Long-term Follow-Up (\> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV and RV volumes, cardiac strain, myocardial fibrosis) for adverse patient outcomes as defined by determinants graft failure, hospitalization, nonfatal myocardial infarction, coronary revascularization, re-transplantation, death.
Sponsors and contacts
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Northwestern University
Lead sponsor
National Institutes of Health (NIH)
Collaborator