Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

• Assessment of myocardial sympathetic innervation (numerical H/M ratio) for identifying risk of adverse cardiac event. [ Time Frame: 24 months or confirmation of 56 adverse cardiac events ] [ Designated as safety issue: No ]
• Quantitative myocardial 123I-mIBG uptake to identify HF subjects at higher risk of earlier HF progression, potentially fatal ventricular arrhythmias, or cardiac death. [ Time Frame: 24 months or confirmation of 56 adverse cardiac events ] [ Designated as safety issue: No ]
• Modeling to predict risk for adverse cardiac events. [ Time Frame: 24 months or confirmation of 56 adverse cardiac events ] [ Designated as safety issue: No ]
• Safety profile [ Time Frame: 24 hours post dose ] [ Designated as safety issue: Yes ]

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 cardiovascular disease.

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.

• Gerson MC, Caldwell JH, Ananthasubramaniam K, Clements IP, Henzlova MJ, Amanullah A, Jacobson AF. Influence of diabetes mellitus on prognostic utility of imaging of myocardial sympathetic innervation in heart failure patients. Circ Cardiovasc Imaging. 2011 Mar 1;4(2):87-93. Epub 2010 Dec 30.
• Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, Agostini D, Weiland F, Chandna H, Narula J; ADMIRE-HF Investigators. Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. J Am Coll Cardiol. 2010 May 18;55(20):2212-21. Epub 2010 Feb 25.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 nervous system.
• Subjects with New York Heart Association Class I or IV heart failure are not eligible.