Recruiting

Allograft Dysfunction

Sponsor:

Paul Kim

Code:

NCT03102125

Conditions

Heart Transplant Failure and Rejection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Regadenoson

Study Details

Brief 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.

Conditions

Heart Transplant Failure and Rejection

Study ID

NCT03102125

Start date

Oct 1, 2019

Status verified date

Apr, 2026

Completion date

Jan 2, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

376 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Regadenoson

For use in stress myocardial perfusion imaging.

Primary outcome measure

  • Myocardial Perfusion Reserve [ Time Frame: 60 months ]

Central Contacts and Locations

Central contacts

Paul Kim, MD

8582460638pjk017@ucsd.edu

Locations

UC San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Paul Kim, MD

8582460638pjk017@ucsd.edu

More Information

Sponsor

Paul Kim

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • heart transplant
  • acute graft rejection
  • chronic graft rejection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Paul Kim on 2026-05-01.