Imaging Heart Nerve Activity in Adults With Heart Failure and Defibrillators
Tests a radioactive imaging agent, 18F-mFBG, in adults with heart failure who have defibrillators.
Plain-language title generated from the registry record
Registry title: 18F-mFBG Imaging for Myocardial Sympathetic Innervation
Key facts
- Where
- Houston, United StatesSee the site
- Phase
- Phase 2
Where in United States
- UT Health HoustonHouston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
- Trial code
- NCT06965621
- Record updated
- 1 July 2026
- Original description
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The study will examine a group of stable patients with heart failure (HF) from ischemic cardiomyopathy. All subjects will have left ventricular ejection fraction (LVEF) ≤35% and implantable cardioverter-defibrillators (ICD). The primary objectives of the study will be to:Read full original descriptionShow less
An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With Heart Failure and Implantable Cardioverter-Defibrillators
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The study will examine a group of stable patients with heart failure (HF) from ischemic cardiomyopathy. All subjects will have left ventricular ejection fraction (LVEF) ≤35% and implantable cardioverter-defibrillators (ICD). The primary objectives of the study will be to:
* document the degree to which 18F-mFBG uptake in the heart is reduced (compared to historical controls) * characterize the distribution of regional abnormalities in relation to findings on rest/stress positron-emission tomography (PET) myocardial perfusion imaging (MPI) * determine if there are global and/or regional differences in myocardial sympathetic innervation between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months Effectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).
Safety data will be collected to identify adverse events [AEs] and serious adverse events [SAEs] and characterize the safety profile of 18F-mFBG.
Inclusion: Stable heart failure from ischemic cardiomyopathy, LVEF < or = 35%, ICD implantation for at least 12 months.
Exclusion: Unstable coronary artery disease, no ICD implantation.