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Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785044
First Posted: November 5, 2008
Last Update Posted: April 26, 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: April 8, 2015  
Study Type: Observational
Study Design: Observational Model: Other;   Time Perspective: Prospective
Condition: Congestive Heart Failure
Intervention: Drug: I-123 mIBG

  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
In the present study MBG313 (NCT00785044), participants previously administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months from the date of administration of 123I-mIBG.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 964 heart failure (HF) participants included in efficacy population of MBG311 (NCT00126425) and MBG312 (NCT00126438), 471 participants signed informed consent and enrolled into extension MBG313 study and provided additional efficacy data. New data from MBG313 study combined with data collected in MBG311 and MBG312 studies for efficacy analysis.

Reporting Groups
  Description
AdreView™- Heart Failure Group HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of adverse cardiac events (ACEs).

Participant Flow:   Overall Study
    AdreView™- Heart Failure Group
STARTED   964 [1] 
Enrolled Participants   471 [2] 
COMPLETED   468 [3] 
NOT COMPLETED   496 
Dosed at non-participating sites                152 
Death                77 
Lost to Follow-up                266 
Withdrawal by Subject                1 
[1] Eligible to participate in MBG313
[2] Out of 964 from MBG311 and MBG312 HF participants, 471 enrolled into the extension MBG313 study.
[3] Data for 471 participants (MBG313) combined with data from MBG311 and MBG312 for efficacy analysis



  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.
No text entered.

Reporting Groups
  Description
AdreView™ - Heart Failure Group HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of ACEs.

Baseline Measures
   AdreView™ - Heart Failure Group 
Overall Participants Analyzed 
[Units: Participants]
 964 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.4  (11.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      192  19.9% 
Male      772  80.1% 


  Outcome Measures

1.  Primary:   Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status   [ Time Frame: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months ]


  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
Designed as a continuation of original phase 3, but objectives were built around analyses of integrated data from both studies. Distinct from endpoints used in MBG311 and MBG312. No intent to analyze current study on single original study basis.


  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 M Zubeldia, M.D.
Organization: GE Healthcare
phone: 011-44-1494-543137
e-mail: jose.zubeldia@ge.com



Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00785044     History of Changes
Other Study ID Numbers: MBG313
First Submitted: November 4, 2008
First Posted: November 5, 2008
Results First Submitted: April 8, 2015
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017