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 — DRUG
    For 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 dysfunction
    Patients 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 function
    Patients 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 vasculopathy
    Patients 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/AMR
    Patients 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

Locations (1)

FacilityCityStateZIPSite coordinators
UC San DiegoLa JollaCalifornia92037
Paul Kim, MD
8582460638

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