The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to
predict cardiac outcome in subjects with heart failure and in comparison to subjects without
This is a phase 3, open-label, multicenter trial to investigate the prognostic usefulness of
123I-mIBG imaging to identify those subjects with New York Heart Association (NYHA) Class II
and III HF who will experience an adverse cardiac event. The study will consist of a maximum
of 587 subjects (525 HF subjects and 62 control subjects) administered 123I-mIBG at
approximately 40 centres in the United States. Subject status will be monitored at 6-week
intervals post-administration of 123I-mIBG to assess the occurrence of adverse cardiac
events. The median follow-up is expected to be 9 months.
- Study subjects must be adults with an established diagnosis of heart failure (New
York Heart Association Class II or III) and reduced left ventricular ejection
fraction (LVEF) (< 35%) or be healthy volunteers without heart disease.
- Healthy volunteers are not eligible if they have a history diabetes mellitus,
signs/symptoms of neurological disease (eg, Parkinson's Disease, multiple system
atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic
- Subjects with New York Heart Association Class I or IV heart failure are not