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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00126438
First Posted: August 4, 2005
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GE Healthcare
Results First Submitted: June 30, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Heart Failure, Congestive
Intervention: Drug: 123I-mIBG (meta-iodobenzylguanidine)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 753 participants were screened, of whom 197 were screen failures due to inclusion/exclusion criteria; 24 withdrawn at participant’s request; 2 withdrawn at investigator’s request and 15 failed to complete all screening procedures.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total 515 participants (453 Heart failure [HF] and 62 control) were enrolled in the study and received a single dose of investigational medicinal product (IMP) at 43 investigational centers.

Reporting Groups
  Description
AdreView - Heart Failure Group AdreView (123I-mIBG [meta-iodobenzylguanidine]): 10 milliCurie (mCi) as a single intravenous dose.
Adreview - Control Group AdreView (123I-mIBG): 10 mCi as a single intravenous dose.

Participant Flow:   Overall Study
    AdreView - Heart Failure Group   Adreview - Control Group
STARTED   453   62 
COMPLETED   419   52 
NOT COMPLETED   34   10 
Withdrawal due to adverse event                1                0 
Lost to Follow-up                22                0 
Protocol Violation                8                8 
Withdrawal by Subject                3                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received IMP manufactured by the sponsor.

Reporting Groups
  Description
AdreView - Heart Failure AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
Adreview - Control Group AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
Total Total of all reporting groups

Baseline Measures
   AdreView - Heart Failure   Adreview - Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 453   62   515 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (12.38)   58.8  (10.84)   61.2  (12.20) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      102  22.5%      19  30.6%      121  23.5% 
Male      351  77.5%      43  69.4%      394  76.5% 


  Outcome Measures

1.  Primary:   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   [ Time Frame: Approximately 24 months from the date of administration of 123I-mIBG ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jose Zubeldia, M.D.
Organization: GE Healthcare
phone: 011-44-1494-543137
e-mail: jose.zubeldia@ge.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00126438     History of Changes
Other Study ID Numbers: MBG312
First Submitted: August 3, 2005
First Posted: August 4, 2005
Results First Submitted: June 30, 2015
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017