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

Official Summary

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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 20 participants

Interventions

• DRUG: 18F-metaFluorobenzylguanidine — PET Radiopharmaceutical to assess myocardial sympathetic innervation
• DRUG: Rubidium-82 — PET Radiopharmaceutical to assess myocardial perfusion

Primary Outcomes

• Quantify the degree of reduced myocardial 18F-mFBG uptake in adult HF subjects with well-characterized coronary heart disease (24 hours from administration of the study drug for PET imaging and safety follow-up)

Secondary Outcomes

• Quanify regional patterns of 18F-mFBG myocardial uptake and distribution (24 hours from administration of the study drug for PET imaging and safety follow-up)
• Perform Safety Data Collection for 18F-mFBG (24 hours from administration of the study drug for safety follow-up)

Trial Locations

• UT Health Houston, Houston, Texas, United States

More Heart Failure Trials

View all Heart Failure clinical trials