Meta-Iodobenzylguanidine 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:
NCT00126425
First received: August 2, 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: 580
Study Start Date: July 2005
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 123I-mIBG (meta-iodobenzylquanidine
Single dose
Drug: 123I-mIBG (meta-iodobenzylguanidine)
Single dose
Other Names:
  • 123I
  • mIBG
  • meta-iodobenzylguanidine

  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: NCT00126425

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: John Lombard 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: NCT00126425     History of Changes
Other Study ID Numbers: MBG311
Study First Received: August 2, 2005
Last Updated: December 2, 2009
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Denmark: Danish Medicines Agency

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 April 22, 2014