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

This study is ongoing, but not recruiting participants.

Sponsored by:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00126438

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 III

MedlinePlus related topics: Heart Failure

Drug Information available for: 3-Iodobenzylguanidine Iobenguane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

Secondary Outcome Measures:

Assessment of myocardial sympathetic innervation (numerical H/M ratio) for identifying risk of adverse cardiac event.
Quantitative myocardial 123I-mIBG uptake to identify HF subjects at higher risk of earlier HF progression, potentially fatal ventricular arrhythmias, or cardiac death.
Modeling to predict risk for adverse cardiac events.
Safety profile

Estimated Enrollment:	525
Study Start Date:	July 2005

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

Study ID Numbers:	MBG312
Study First Received:	August 3, 2005
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00126438
Health Authority:	United States: Food and Drug Administration

Keywords provided by GE Healthcare:

Heart Failure
nuclear cardiology
sympathetic innervation
123I-mIBG

Study placed in the following topic categories:

Heart Failure
Heart Diseases
3-Iodobenzylguanidine

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009