Allograft Dysfunction in Heart Transplant

Heart Transplant Failure and Rejection Clinical Trial

Official title: Defining Mechanisms for Cardiac Allograft Dysfunction to Improve Allograft Longevity and Survival in Heart-Transplant Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Transplant Failure and Rejection

• NCT number: NCT03102125
• Study type: Interventional
• Source: University of California, San Diego
• Contact: Paul Kim, MD
• Phone: 8582460638
• Email: pjk017@ucsd.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2019
• Completion date: December 2, 2024