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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: I-123 mIBG


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group<br>No participants received any drug administration. No intervention conducted. | Drug: I-123 mIBG<br>* This was an observational study. Participants were previously dosed in separate study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status | The numerical value of 123 I-mIBG uptake (H/M ratio) at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis. | From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, MIBG, 123I-mIBG