376 Participants Needed

Regadenoson for Heart Transplant Rejection

PK
Overseen ByPaul Kim, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Paul Kim
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is Regadenoson generally safe for humans?

The research does not provide specific safety data for Regadenoson, but it highlights that cardiac adverse effects are common with many drugs, especially those affecting cardiovascular functions. It's important to consult with healthcare professionals for personalized safety information.12345

How does the drug Regadenoson differ from other treatments for heart transplant rejection?

Regadenoson is unique because it is primarily used as a stress agent in cardiac imaging, and its application for heart transplant rejection is novel. Unlike traditional immunosuppressive drugs like cyclosporine or prednisone, Regadenoson works by affecting blood flow and heart rate, which may offer a different approach to managing rejection.678910

Research Team

PK

Paul Kim, MD

Principal Investigator

UC San Diego

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.
I had a heart transplant more than three months ago.

Exclusion Criteria

I have uncontrolled asthma or COPD.
I have had seizures that affect my whole body.
Resting heart rate greater than 120 or less than 45 beats per minute
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Cardiac MRI and single cell sequencing are performed to evaluate cardiac allograft function

1-2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for major adverse cardiovascular events (MACE) and other outcomes

12 months
Regular visits as per clinical care

Long-term Follow-up

Participants are monitored for long-term outcomes including stenotic microvasculopathy and MACE

60 months

Treatment Details

Interventions

  • Regadenoson
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Paul Kim

Lead Sponsor

Trials
2
Recruited
390+

Findings from Research

A comprehensive database of 396,985 drug-related cardiac adverse effects (AEs) linked to 1,632 approved drugs was created, revealing significant clusters of AEs affecting heart function, such as arrhythmias and heart failure.
The study identified that cardiac AEs are highly correlated with drugs targeting cardiovascular functions and specific mechanisms of action, including interactions with various receptors like alpha- and beta-adrenergic receptors, which may help predict and understand these adverse effects.
Prediction of drug-related cardiac adverse effects in humans--A: creation of a database of effects and identification of factors affecting their occurrence.Matthews, EJ., Frid, AA.[2013]
In 2011, the MedWatch system received 600,000 adverse event reports, highlighting its role in improving drug and device safety awareness, but it also faces challenges with reporting bias and data accuracy.
A study analyzing 10.2 million reports found that while patient information was mostly accurate, suspect product data was often incomplete or incorrect, with significant gaps in key details like dosage and product lot numbers, which could lead to incorrect conclusions about drug safety.
Evaluating the completeness and accuracy of MedWatch data.Getz, KA., Stergiopoulos, S., Kaitin, KI.[2017]
In a review of 306 cardiovascular adverse events associated with sipuleucel-T from a large pharmacovigilance database, significant risks were identified, including myocardial ischemia, congestive heart failure, and supraventricular tachycardia, particularly in patients with cardiovascular risk factors.
Among patients experiencing congestive heart failure, 26% of cases were fatal, indicating a serious risk associated with sipuleucel-T, suggesting the need for close monitoring of cardiac function during treatment.
Sipuleucel-T associated inflammatory cardiomyopathy: a case report and observations from a large pharmacovigilance database.Moey, MYY., Jiwani, RA., Takeda, K., et al.[2021]

References

Prediction of drug-related cardiac adverse effects in humans--A: creation of a database of effects and identification of factors affecting their occurrence. [2013]
Evaluating the completeness and accuracy of MedWatch data. [2017]
Sipuleucel-T associated inflammatory cardiomyopathy: a case report and observations from a large pharmacovigilance database. [2021]
Cardiovascular safety of liraglutide assessed in a patient-level pooled analysis of phase 2: 3 liraglutide clinical development studies. [2022]
Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. [2023]
Reversal of cardiac transplant rejection without massive immunosuppression. [2013]
Clinical results of steroid-free induction immunosuppression after heart transplantation. [2021]
Oral steroid pulse without taper for the treatment of asymptomatic moderate cardiac allograft rejection. [2019]
Sirolimus, a new potent immunosuppressant agent for refractory cardiac transplantation rejection: two case reports. [2013]
Immunosuppression following cardiac transplantation. [2021]