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Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00126438
First received: August 3, 2005
Last updated: December 2, 2009
Last verified: December 2009

August 3, 2005
December 2, 2009
July 2005
July 2008   (final data collection date for primary outcome measure)
Assessment of myocardial sympathetic innervation (as either normal or abnormal) for identifying risk of adverse cardiac event. [ Time Frame: 24 months or confirmation of 56 adverse cardiac events ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00126438 on ClinicalTrials.gov Archive Site
  • Assessment of myocardial sympathetic innervation (numerical H/M ratio) for identifying risk of adverse cardiac event. [ Time Frame: 24 months or confirmation of 56 adverse cardiac events ] [ Designated as safety issue: No ]
  • Quantitative myocardial 123I-mIBG uptake to identify HF subjects at higher risk of earlier HF progression, potentially fatal ventricular arrhythmias, or cardiac death. [ Time Frame: 24 months or confirmation of 56 adverse cardiac events ] [ Designated as safety issue: No ]
  • Modeling to predict risk for adverse cardiac events. [ Time Frame: 24 months or confirmation of 56 adverse cardiac events ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: 24 hours post dose ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease
An Open-Label, Multicenter, Phase 3 Study Evaluating the Prognostic Usefulness of I-123 mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Heart Failure, Congestive
Drug: 123I-mIBG (meta-iodobenzylguanidine)
Single Dose
Other Names:
  • MIBG
  • I123
Experimental: 123I-mIBG (meta-iodobenzylguanidine)
Intervention: Drug: 123I-mIBG (meta-iodobenzylguanidine)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
515
September 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00126438
MBG312
Yes
Arnold Jacobson, M.D., GE Healthcare
GE Healthcare
Not Provided
Study Director: John Strohmeyer GE Healthcare
GE Healthcare
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP