18F-mFBG Imaging for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging agent, 18F-metaFluorobenzylguanidine (18F-mFBG), to evaluate its effectiveness in showing heart nerve activity in individuals with heart failure. The focus is on patients with heart failure due to ischemic cardiomyopathy, a condition caused by reduced blood flow to the heart, who have an implanted device called an ICD to prevent dangerous heart rhythms. Researchers will compare heart images from those whose ICD activated in the past year with those whose ICD did not. The study aims to better understand heart nerve activity and ensure the imaging's safety. Individuals with stable heart failure, an ICD, and a heart function measurement of 35% or less may be suitable for this trial. As a Phase 2 trial, this research measures the imaging agent's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in heart failure treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that 18F-mFBG is safe for heart failure patients?
Earlier studies have used a substance called 18F-metaFluorobenzylguanidine (18F-mFBG) to examine heart nerve activity with PET scans, aiding in understanding heart function in people with heart failure. Research has shown that 18F-mFBG is generally safe for patients, with no major safety issues reported.
As this is a Phase 2 trial, the safety of 18F-mFBG has already been tested in smaller groups. Phase 2 trials confirm the safety of a treatment and check for any side effects. While this trial will continue to gather safety information, earlier studies suggest that most people tolerate 18F-mFBG well.12345Why are researchers excited about this trial?
Researchers are excited about 18F-metaFluorobenzylguanidine (18F-mFBG) imaging for heart failure because it offers a new way to visualize heart health using advanced imaging techniques. Unlike typical heart failure treatments that focus on managing symptoms or improving heart function, 18F-mFBG provides detailed insights into nerve activity in the heart, which could help doctors better understand and treat the condition. This imaging technique uses a special tracer that highlights areas of the heart with abnormal nerve activity, potentially leading to more personalized and effective treatment strategies for patients with ischemic cardiomyopathy. By targeting the underlying nerve issues, 18F-mFBG imaging could open up new avenues in heart failure management that current medications or devices can't address alone.
What evidence suggests that 18F-mFBG is effective for heart failure imaging?
Research has shown that 18F-mFBG holds promise for heart imaging by helping doctors assess nerve function in the heart. Previous studies found that patients with heart problems had lower levels of 18F-mFBG in their hearts, indicating its effectiveness in highlighting nerve issues. In this trial, researchers are administering 18F-mFBG to heart failure patients with ischemic cardiomyopathy, both with and without recent ICD discharge, to compare its effectiveness. This imaging agent is being compared to other nuclear imaging agents like 123I-mIBG, which have been used to evaluate heart nerve function. Early results suggest that 18F-mFBG may provide accurate insights into heart health, particularly in individuals with heart failure due to ischemic cardiomyopathy, a condition where the heart receives insufficient blood.16789
Who Is on the Research Team?
K. Lance Gould, MD
Principal Investigator
Professor of Medicine, McGovern Medical School, UTHealth
Are You a Good Fit for This Trial?
This trial is for stable heart failure patients with ischemic cardiomyopathy, who have a left ventricular ejection fraction (LVEF) of 35% or less and have had an implantable cardioverter-defibrillator (ICD) for at least a year. It's not open to those without ICDs or with unstable coronary artery disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Administration of 82Rb and 18F-mFBG intravenously to heart failure patients for PET imaging
Safety Follow-up
Safety data collection for 18F-mFBG, including adverse events and serious adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 18F-metaFluorobenzylguanidine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Lead Sponsor
University of Texas
Collaborator