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

This trial accepts healthy volunteers

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 population

The study population includes pediatric and non-pediatric healthy volunteers; as well as, non-pediatric and pediatric heart transplant patients.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

247 Participants
are divided into 3 treatment groups
Group A: Aim#1 Development1 intervention
Group B: Aim#2 Cardiac MRI in Pediatric HTx & Donor-Recipient Mismatch1 intervention
Group C: Aim#3 Longitudinal patient outcome study1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
4 years
2

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)

Time frame
4 years

Secondary outcomes

1

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.

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Institutes of Health (NIH)

Collaborator