Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

General Electric (GE)

Status and phase: Completed; Phase 3

Conditions: Heart Failure, Congestive

Treatments: Drug: 123I-mIBG (meta-iodobenzylguanidine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00126425

MBG311

Details and patient eligibility

About

The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcomes in subjects with heart failure and in comparison to subjects without cardiovascular disease.

Enrollment: 587 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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587 participants in 1 patient group

123I-mIBG (meta-iodobenzylquanidine

Experimental group

Description:

Single dose

Treatment:

Drug: 123I-mIBG (meta-iodobenzylguanidine)