Expired Study
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Princeton, New Jersey 08540


Purpose:

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


Study summary:

This is a phase 3, open-label, multicenter trial to investigate the prognostic usefulness of 123I-mIBG imaging to identify those subjects with New York Heart Association (NYHA) Class II and III HF who will experience an adverse cardiac event. The study will consist of a maximum of 587 subjects (525 HF subjects and 62 control subjects) administered 123I-mIBG at approximately 40 centres in the United States. Subject status will be monitored at 6-week intervals post-administration of 123I-mIBG to assess the occurrence of adverse cardiac events. The median follow-up is expected to be 9 months.


Criteria:

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.


NCT ID:

NCT00126438


Primary Contact:

Study Director
John Strohmeyer
GE Healthcare


Backup Contact:

N/A


Location Contact:

Princeton, New Jersey 08540
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 18, 2017

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