Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction

• Status: Completed
• Trial end date: 2016-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft dysfunction in contrast to those with normal graft function. The investigators hypothesize that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial perfusion reserve, related to microvascular allograft vasculopathy, compared to those with normal graft function.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Patricia Kim Phuong Nguyen; Paul Kim
• Collaborator: Astellas Pharma Inc
• Treatments: Regadenoson

Criteria

Inclusion Criteria:

• Age greater than or equal to 18 years old.

• At least three months status post heart transplantation.

• Heart-transplant patients with normal graft function (left ventricular ejection fraction equal to or greater than 55%) and no prior history of clinically significant acute rejection episodes that required modification of the immunosuppressive regimen or cardiac allograft vasculopathy.

• Heart-transplant patients with nonspecific allograft dysfunction (left ventricular ejection fraction equal to or less than 50% AND decrease from post-transplant baseline ejection fraction by an absolute difference of 10% or greater, no formal diagnosis of allograft vasculopathy by coronary angiogram or coronary vascular ultrasonography, and no history of prior acute rejection episodes known to have decreased left ventricular ejection fraction to or less than 50%).

Exclusion Criteria:

• Biopsy proven acute rejection episode in the past 3 months.

• Patients with symptoms or signs of acute myocardial ischemia or recent acute coronary syndrome in the past 3 months.

• Uncontrolled obstructive ventilatory disease including asthma and COPD.

• Second or third degree AV nodal block.

• Sinus node dysfunction.

• Contraindications to MRI including pacemakers or implantable cardioverter-defibrillators.

• Renal dysfunction with an estimated GFR less than 30 mL/min/1.73m2.

• Prior adverse reaction to either regadenoson or gadolinium contrast. Prior adverse reaction to adenosine will be assessed on a case-by-case basis.

• Any invasive procedure, including endomyocardial biopsy and left coronary angiogram, performed within one week.

• Systolic blood pressure greater than 180 or less than 85 mmHg.

• Diastolic blood pressure greater than 120 or less than 40 mmHg.

• Resting heart rate greater than 120 or less than 45 beats per minute.

• Severe claustrophobia.