Regadenoson for Heart Transplant Rejection

UC San Diego, La Jolla, CA
Heart Transplant RejectionRegadenoson - Drug
All Sexes
What conditions do you have?

Study Summary

This trial will use MRI and cell sequencing to look for early evidence of heart transplant rejection and determine the underlying causes.

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 60 months

60 months
LV end-diastolic volume index
LV mass index
Major adverse cardiovascular events
Myocardial Perfusion Reserve
Number of stenotic microvasculopathy by histopathologic review of endomyocardial biopsy samples
Percentage of different T-cell subsets by single cell RNAseq
Rest and stress myocardial blood flow
extracellular volumes
myocardial strain rate
native T1 and T2 myocardial values

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4 Treatment Groups

1 of 4
Nonspecific allograft dysfunction
1 of 4
Normal graft function
1 of 4
Cardiac allograft vasculopathy
1 of 4

Experimental Treatment

376 Total Participants · 4 Treatment Groups

Primary Treatment: Regadenoson · No Placebo Group · Phase 4

Experimental Group · 1 Intervention: Regadenoson · Intervention Types: Drug
Nonspecific allograft dysfunction
Experimental Group · 1 Intervention: Regadenoson · Intervention Types: Drug
Normal graft function
Experimental Group · 1 Intervention: Regadenoson · Intervention Types: Drug
Cardiac allograft vasculopathy
Experimental Group · 1 Intervention: Regadenoson · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 60 months

Who is running the clinical trial?

Paul KimLead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
Paul Kim, MDPrincipal Investigator - UC San Diego
Regents of the University of California - UCSD Medical Group, UCSD Medical Center-Hillcrest
3 Previous Clinical Trials
412 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

How many participants are being welcomed into this trial?

"Affirmative, the clinical trial is still recruiting participants according to's records. This investigation was originally posted on October 1st 2019 and recently updated on November 3rd 2021 with a goal of enrolling 376 patients from one medical facility." - Anonymous Online Contributor

Unverified Answer

Is this pioneering clinical trial the first of its kind?

"Clinical studies of regadenoson commenced in 2014, with Astellas Scientific & Medical Affairs, Inc. sponsoring the first trial involving 300 participants. Subsequently approved by Phase 4 drug approval, 7 current trials are ongoing across 6 distinct countries and 12 cities." - Anonymous Online Contributor

Unverified Answer

Has the U.S Food and Drug Administration (FDA) validated the use of Regadenoson?

"Regadenoson is proven to be safe as evidenced by its Phase 4 status, and thus earned a score of 3 on our 1-3 scale." - Anonymous Online Contributor

Unverified Answer

Are there any other documented instances of Regadenoson being tested as a treatment?

"Presently, 7 clinical trials are researching the effects of Regadenoson with 0 conducted in Phase 3. Multiple locations across the United States are participating, particularly around Houston Texas; 20 sites total have been identified as possible places to conduct this medical research." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies available in this clinical trial?

"This clinical trial, which was initially published on October 1st 2019 and revised November 3rd 2021 according to the information found at is actively looking for participants." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.