Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event

An Open-label, Multicentre, Phase 3 Study to Demonstrate the Prognostic Usefulness of 123I-mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event During 24 Months Followup

The study was designed to study the utility of meta-iodobenzylguanidine (123I-mIBG) imaging to identify those participants with heart failure who would experience an adverse cardiac event during 24 months of follow-up from the administration date of 123I-mIBG in previous studies MBG311 or MBG312.

Inclusion Criteria:

• The subject was a Heart Failure subject who signed informed consent for MBG311, MBG312, or MBG312C.
• The subject was administered 123I-mIBG in MBG311, MBG312, or MBG312C.
• The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311, MBG312, or MBG312C.
• The subject agreed to allow the investigator access to medical records, including those relating to subject death should this occur.

Exclusion Criteria:

• The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.
• The subject was considered lost-to-follow-up (6 months without contact) in MBG311, MBG312, or MBG312C.