Allograft Dysfunction in Heart Transplant

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    376
  • sponsor
    Paul Kim
Updated on 24 January 2021

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.

Description

Adult heart-transplant patients, excluding those with a GFR less than 30 mL/min/1.73m2, contraindications to MRI and allergies to either regadenoson or gadolinium contrast, will be enrolled over 60 months. Patients will be recruited from UCSD. The investigators will specifically enroll all eligible heart-transplant patients.

Brief protocol:

Cardiac MRI is performed. Cine images in standard views are obtained. T1 and T2 mapping sequences are performed on short axis images pre- and post-gadolinium contrast. For stress imaging, intravenous regadenoson is given as a 0.4 mg bolus followed by a 5 mL saline flush. After 30 seconds, short-axis images are acquired for 30 consecutive heartbeats with administration of gadolinium. Rest imaging is performed 30 minutes after stress imaging. Lastly, late gadolinium enhancement images are obtained in standard views. Images are analyzed offline by a blinded independent reader. Patients will be followed for at least 1 year after enrollment for MACE.

Peripheral blood and endomyocardial biopsies will also be collected, timing as per usual clinical care as well as for-cause, for single cell RNAseq analyses.

Details
Condition Heart Transplant Failure and Rejection
Treatment Regadenoson
Clinical Study IdentifierNCT03102125
SponsorPaul Kim
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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