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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

471 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-02-28

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.

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Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group

No participants received any drug administration. No intervention conducted.

I-123 mIBG

Intervention Type DRUG

This was an observational study. Participants were previously dosed in separate study.

Interventions

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I-123 mIBG

This was an observational study. Participants were previously dosed in separate study.

Intervention Type DRUG

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* The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No