NCT00126425

Brief Summary

The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcomes in subjects with heart failure and in comparison to subjects without cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
587

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8 years until next milestone

Results Posted

Study results publicly available

December 13, 2016

Completed
Last Updated

December 13, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

August 2, 2005

Results QC Date

June 30, 2015

Last Update Submit

October 19, 2016

Conditions

Heart Failure, Congestive

Keywords

Heart Failurenuclear cardiologysympathetic innervation123I-mIBG

Outcome Measures

Primary Outcomes (1)

  • Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio

    H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as 'Low' and 'High' based on being \<1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events.

    Approximately 24 months from the date of administration of 123I-mIBG

Study Arms (1)

123I-mIBG (meta-iodobenzylquanidine

EXPERIMENTAL

Single dose

Drug: 123I-mIBG (meta-iodobenzylguanidine)

Interventions

123I-mIBG (meta-iodobenzylguanidine)DRUG

Single dose

Also known as: Iobenguane, mIBG, meta-iodobenzylguanidine
123I-mIBG (meta-iodobenzylquanidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

Related Publications (3)

  • Hachamovitch R, Nutter B, Menon V, Cerqueira MD. Predicting Risk Versus Predicting Potential Survival Benefit Using 123I-mIBG Imaging in Patients With Systolic Dysfunction Eligible for Implantable Cardiac Defibrillator Implantation: Analysis of Data From the Prospective ADMIRE-HF Study. Circ Cardiovasc Imaging. 2015 Dec;8(12):e003110. doi: 10.1161/CIRCIMAGING.114.003110.

    PMID: 26666380DERIVED

  • Gerson MC, Caldwell JH, Ananthasubramaniam K, Clements IP, Henzlova MJ, Amanullah A, Jacobson AF. Influence of diabetes mellitus on prognostic utility of imaging of myocardial sympathetic innervation in heart failure patients. Circ Cardiovasc Imaging. 2011 Mar;4(2):87-93. doi: 10.1161/CIRCIMAGING.110.954784. Epub 2010 Dec 30.

    PMID: 21193691DERIVED

  • Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, Agostini D, Weiland F, Chandna H, Narula J; ADMIRE-HF Investigators. Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. J Am Coll Cardiol. 2010 May 18;55(20):2212-21. doi: 10.1016/j.jacc.2010.01.014. Epub 2010 Feb 25.

    PMID: 20188504DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

3-Iodobenzylguanidine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsIodobenzenesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHydrocarbons, IodinatedHydrocarbons, Halogenated

Results Point of Contact

Title
Jose M Zubeldia, M.D.
Organization
GE Healthcare
jose.zubeldia@ge.com
011-44-1494-543137

Study Officials

  • John Lombard

    GE Healthcare

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 4, 2005

Study Start

July 1, 2005

Primary Completion

July 1, 2008

Study Completion

December 1, 2008

Last Updated

December 13, 2016

Results First Posted

December 13, 2016

Record last verified: 2016-10

Locations

US(1)