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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
History of Changes
  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.


Condition Intervention Phase
Heart Failure, Congestive
 Drug: 123I-mIBG (meta-iodobenzylguanidine)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 515
Study Start Date: July 2005
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 123I-mIBG (meta-iodobenzylguanidine) Drug: 123I-mIBG (meta-iodobenzylguanidine)
Single Dose
Other Names:
  • MIBG
  • I123

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126438

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: John Strohmeyer GE Healthcare
  More Information

No publications provided by GE Healthcare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Arnold Jacobson, M.D., GE Healthcare
ClinicalTrials.gov Identifier: NCT00126438     History of Changes
Other Study ID Numbers: MBG312
Study First Received: August 3, 2005
Last Updated: December 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GE Healthcare:
Heart Failure
nuclear cardiology
sympathetic innervation
123I-mIBG

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Failure
Heart Diseases
3-Iodobenzylguanidine
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013