Allograft Dysfunction in Heart Transplant
Part of paid clinical trials in La Jolla, California.
- Sponsor
- Paul Kim
- Study ID
- NCT03102125
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Heart Transplant Failure and Rejection
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Regadenoson — DRUGFor use in stress myocardial perfusion imaging.
Study Details
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.
Key Dates
- Start date
- Oct 1, 2019
- Status verified
- Apr 2026
- Primary completion
- Jan 1, 2027
- Completion
- Jan 2, 2027
Study Design
- Enrollment
- 376 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Nonspecific allograft dysfunctionPatients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Peripheral blood and endomycardial biopsies will also be obtained for single cell RNAseq analyses.
- Experimental: Normal graft functionPatients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Peripheral blood and endomycardial biopsies will also be obtained for single cell RNAseq analyses.
- Experimental: Cardiac allograft vasculopathyPatients with allograft dysfunction from known cardiac allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Peripheral blood and endomycardial biopsies will also be obtained for single cell RNAseq analyses.
- Experimental: ACR/AMRPatients with allograft dysfunction from prior episodes of acute cellular or antibody mediated rejection will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Peripheral blood and endomycardial biopsies will also be obtained for single cell RNAseq analyses.
Primary Outcome Measure
Myocardial Perfusion Reserve [ Time Frame: 60 months ]
Central Contacts
- Paul Kim, MD8582460638
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92037 |
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