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Regadenoson for Heart Transplant Rejection

Phase 4
Recruiting
Led By Paul Kim, MD
Research Sponsored by Paul Kim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than or equal to 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for adults over 18 who had a heart transplant at least three months ago. It's not for those with recent heart issues, uncontrolled lung diseases like asthma or COPD, seizure history, recent organ rejection, certain heart rhythm problems, MRI contraindications (like pacemakers), severe kidney issues, past bad reactions to regadenoson or gadolinium contrast agents, extreme blood pressure or pulse rates.Check my eligibility
What is being tested?
The study tests if the drug Regadenoson can help detect early signs of heart transplant rejection using advanced imaging (cardiac MRI) and detailed cell analysis. The goal is to understand the molecular and physical changes that indicate graft dysfunction.See study design
What are the potential side effects?
Regadenoson may cause side effects such as headaches, shortness of breath, chest pain or tightness; stomach discomfort; feeling dizzy or lightheaded; throat, neck or jaw discomfort; sweating; numbness in arms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Myocardial Perfusion Reserve
Secondary outcome measures
LGE %
LV end-diastolic volume index
LV mass index
+5 more
Other outcome measures
Major adverse cardiovascular events
Number of stenotic microvasculopathy by histopathologic review of endomyocardial biopsy samples
Percentage of different T-cell subsets by single cell RNAseq

Trial Design

4Treatment groups
Experimental Treatment
Group I: Normal graft functionExperimental Treatment1 Intervention
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.
Group II: Nonspecific allograft dysfunctionExperimental Treatment1 Intervention
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.
Group III: Cardiac allograft vasculopathyExperimental Treatment1 Intervention
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.
Group IV: ACR/AMRExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regadenoson
2012
Completed Phase 4
~5300

Find a Location

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

Media Library

Regadenoson Clinical Trial Eligibility Overview. Trial Name: NCT03102125 — Phase 4
Heart Transplant Rejection Research Study Groups: Normal graft function, Cardiac allograft vasculopathy, ACR/AMR, Nonspecific allograft dysfunction
Heart Transplant Rejection Clinical Trial 2023: Regadenoson Highlights & Side Effects. Trial Name: NCT03102125 — Phase 4
Regadenoson 2023 Treatment Timeline for Medical Study. Trial Name: NCT03102125 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being welcomed into this trial?

"Affirmative, the clinical trial is still recruiting participants according to clinicaltrials.gov'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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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 clinicaltrials.gov is actively looking for participants."

Answered by AI
Recent research and studies
~0 spots leftby Apr 2024