Allograft Dysfunction in Heart Transplant

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will evaluate for early evidence of cardiac allograft dysfunction by cardiac MRI and single cell sequencing to determine underlying molecular and macroscopic causes.

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

Details

• Lead Sponsor: 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.

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.

• History of generalized tonic-clonic seizures.

• Second or third degree AV nodal block.

• Sinus node dysfunction.

• Contraindications to MRI including cardiovascular implantable electronic devices.

• 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 or dipyridamole will be assessed on a case-by-case basis.

• 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.