Principal Investigator: Josef Stehlik
Keywords: Heart Failure , Transplant Department: Cardiovascular Medicine
IRB Number: 00104793
Specialty: Cardiology, Cardiology, Cardiology
Sub Specialties: Heart Failure, Heart Transplant
Recruitment Status: Recruiting

Contact Information

Jennifer Hong
jennifer.hong@hsc.utah.edu
801-213-2050

Brief Summary

Purpose

To demonstrate the impact of the Molecular Microscope system as standard of care for clinically warranted biopsies.

Primary objectives:

  1. Develop the Reference Set for heart transplants (EMB) with molecular, histologic, DSA, and clinical data. (We already have 330 EMBs but we aim for 650-700).
  2. Adapt the MMDx system to assess and report EMBs, incorporating the rejection and injury principles discovered in kidney.
  3. Validate and refine the system by reporting in real time (48-72 hours) 300 new heart biopsies and obtaining feedback from key opinion leader clinicians. This involves unselected, prospectively collected, standard of care biopsies for clinical indication and protocol biopsies above average risk of abnormality in North American, European, and Australian Centers.

Primary objectives:

  1. Compare MMDx readings to standard-of-care readings for predicting response to treatment/outcomes;
  2. Refine the diagnostic and prognostic tests and the reports;
  3. Determine the effect of treatment on clinical features;
  4. Determine the changes over time in medically indicated follow-up biopsies;
  5. Develop a new transplant disease classification incorporating MMDx and conventional measurements.

 

Inclusion Criteria

All heart transplant recipients ≥18yrs of age undergoing an EMB for clinical indications and protocol biopsies above average risk of abnormality, as determined by their physician or surgeon, will be eligible to enroll in the study, regardless of time post transplant. Patients are enrolled on the basis of standard of care biopsies, including surveillance biopsies in high risk patients (according to the Center definition), with informed consent. INTERHEART will accept any standard of care biopsies of heart transplants from the participating centers during the period of enrollment, including protocol biopsies in high risk patients (DSA positive or follow-up after treatment).

 

Exclusion Criteria

  1. Patients will be excluded from the study if they decline participation
  2. Unable to give informed consent 
  3. Are pregnant women