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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Heart Failure
Cardiovascular Diseases
Heart Diseases
3-Iodobenzylguanidine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 30, 2014