Trial Outcomes & Findings for Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event (NCT NCT00785044)

Results Overview

The numerical value of 123 I-mIBG uptake (H/M ratio) 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. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.

Recruitment status

COMPLETED

Target enrollment

471 participants

Primary outcome timeframe

From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months

Results posted on

2017-04-26

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	964
Overall Study Enrolled Participants	471
Overall Study COMPLETED	468
Overall Study NOT COMPLETED	496

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study Dosed at non-participating sites	152
Overall Study Death	77
Overall Study Lost to Follow-up	266
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AdreView™ - Heart Failure Group n=964 Participants 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.
Age, Continuous	62.4 years STANDARD_DEVIATION 11.85 • n=93 Participants
Sex: Female, Male Female	192 Participants n=93 Participants
Sex: Female, Male Male	772 Participants n=93 Participants

PRIMARY outcome

Timeframe: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months

Population: Efficacy population was 961 participants who received IMP and had a consensus H/M ratio on 3 hour 50 minute planar image in MBG 311 or MBG 312. Here, number of participant analyzed = number of participants with available data for this endpoint.

The numerical value of 123 I-mIBG uptake (H/M ratio) 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. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.

Outcome measures

Outcome measures
Measure	AdreView™ - HF Group (With No Adverse Cardiac Events) n=829 Participants HF participants administered AdreView™ (123I-mIBG \[meta-iodobenzylguanidine\]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) with no ACEs monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG.	AdreView™- HF Group (With Adverse Cardiac Events) n=132 Participants HF participants administered AdreView™ (123I-mIBG \[meta-iodobenzylguanidine\]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) with ACEs monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG.
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	1.451 Ratio Standard Deviation 0.2033	1.394 Ratio Standard Deviation 0.1885

Adverse Events

AdreView™ - Heart Failure Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jose M Zubeldia, M.D.

GE Healthcare

Phone: 011-44-1494-543137

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
Publication restrictions are in place

Restriction type: OTHER