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

General Electric (GE)

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Drug: I-123 mIBG

Study type: Observational

Funder types: Industry

Identifiers

NCT00785044

MBG313

Details and patient eligibility

About

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.

Enrollment: 471 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.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

Trial design

471 participants in 1 patient group

Group

Description:

No participants received any drug administration. No intervention conducted.

Treatment:

Drug: I-123 mIBG