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

Phase 3

Completed

• Conditions: Heart Failure, Congestive
• Interventions: Drug: 123I-mIBG (meta-iodobenzylguanidine)

• Registration Number: NCT00126425
• Lead Sponsor: GE Healthcare

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-02
• Study First Submitted QC: 2005-08-03
• Study First Posted: 2005-08-04
• Primary Completion: 2008-07
• Study Completion: 2008-12
• Results First Submitted: 2015-06-30
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-19
• Last Update Submitted: 2016-10-19
• Results First Posted: 2016-12-13
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 587

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
123I-mIBG (meta-iodobenzylquanidine	123I-mIBG (meta-iodobenzylguanidine)	Single dose

Primary Outcome Measures

Name	Time	Method
Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio	Approximately 24 months from the date of administration of 123I-mIBG	H/M ratio for 123I-mIBG uptake 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. Assessments were done by 3 independent readers. H/M ratios were categorized as 'Low' and 'High' based on being \<1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States