Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

Heart Failure, Congestive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126425
• Other study ID #: MBG311
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2005
• Last updated: December 2, 2009
• Start date: July 2005
• Est. completion date: December 2008

Study information

• Verified date: December 2009
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Sweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCzech Republic: State Institute for Drug ControlSpain: Spanish Agency of MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• 123I-mIBG (meta-iodobenzylguanidine)
Single dose

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of myocardial sympathetic innervation (as either normal or abnormal) for identifying risk of adverse cardiac event.		24 months or confirmation of 56 adverse cardiac events	No
Secondary	Assessment of myocardial sympathetic innervation (numerical H/M ratio) for identifying risk of adverse cardiac event.		24 months or confirmation of 56 adverse cardiac events	No
Secondary	Quantitative myocardial 123I-mIBG uptake to identify HF subjects at higher risk of earlier HF progression, potentially fatal ventricular arrhythmias, or cardiac death.		24 months or confirmation of 56 adverse cardiac events	No
Secondary	Modeling to predict risk for adverse cardiac events.		24 months or confirmation of 56 adverse cardiac events	No
Secondary	Safety profile		24 hours post dose	Yes