Trial Outcomes & Findings for Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease (NCT NCT00126425)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

587 participants

Primary outcome timeframe

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

Results posted on

2016-12-13

Participant Flow

A total of 712 participants were screened, of whom 587 participants were enrolled.

Of 587 participants, 6 were withdrawn prior to receiving investigational medicinal product (IMP). A total of 581 participants (533 Heart Failure \[HF\] and 48 control), were dosed at the 54 centers. However, one of these participants was administered 123I-mIBG not manufactured by the sponsor, and therefore excluded from all analyses.

Participant milestones

Participant milestones
Measure	AdreView--Heart Failure Group 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.	AdreView--Control Group 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
Overall Study STARTED	539	48
Overall Study COMPLETED	498	37
Overall Study NOT COMPLETED	41	11

Reasons for withdrawal

Reasons for withdrawal
Measure	AdreView--Heart Failure Group 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.	AdreView--Control Group 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
Overall Study Withdrawal by Subject	17	1
Overall Study Lost to Follow-up	8	4
Overall Study Protocol Violation	9	6
Overall Study Adverse Event	1	0
Overall Study Failed Inclusion Exclusion Criteria	1	0
Overall Study Other	5	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AdreView--Heart Failure Group n=532 Participants 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at a high risk of heart failure.	AdreView--Control Group n=48 Participants 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at no risk of heart failure.	Total n=580 Participants Total of all reporting groups
Age, Continuous	63.0 years STANDARD_DEVIATION 11.33 • n=5 Participants	56.4 years STANDARD_DEVIATION 11.97 • n=7 Participants	61.3 years STANDARD_DEVIATION 11.37 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	20 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	440 Participants n=5 Participants	28 Participants n=7 Participants	468 Participants n=5 Participants

PRIMARY outcome

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

Population: Primary efficacy population was 520 participants in HF group who received IMP and had a diagnostic (optimal or sub-optimal) 3 hour 50 minute planar image. Images from 2 HF participants were inadvertently not submitted and not presented to blinded readers. Here, N=efficacy population and n=number of participants assessed by specific readers.

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.

Outcome measures

Outcome measures
Measure	AdreView-Heart Failure Group With High H/M Ratio n=116 Participants Participants in HF group who had high H/M ratio (more than or equal to 1.6)	AdreView-Heart Failure Group With Low H/M Ratio n=403 Participants Participants in HF group who had low H/M ratio (less than 1.6)
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 Reader A (n=115, 401)	14 number of adverse cardiac events	100 number of adverse cardiac events
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 Reader B (n=115, 403)	14 number of adverse cardiac events	100 number of adverse cardiac events
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 Reader C (n=116, 402)	14 number of adverse cardiac events	100 number of adverse cardiac events

Adverse Events

AdreView--Heart Failure Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

AdreView --Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AdreView--Heart Failure Group n=532 participants at risk 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.	AdreView --Control Group n=48 participants at risk 123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
Cardiac disorders Death	0.19% 1/532 • Number of events 1 • Up to 30 hours after administration of the IMP A total of 7 participants were withdrawn from the study, of which 6 were withdrawn prior to receiving IMP and 1 patient received 123I-mIBG of another manufacturer. Therefore, this latter participant was withdrawn from all analyses.	0.00% 0/48 • Up to 30 hours after administration of the IMP A total of 7 participants were withdrawn from the study, of which 6 were withdrawn prior to receiving IMP and 1 patient received 123I-mIBG of another manufacturer. Therefore, this latter participant was withdrawn from all analyses.

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