Trial Outcomes & Findings for Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease (NCT NCT00126438)
NCT ID: NCT00126438
Last Updated: 2018-03-14
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. Data analysis to assess the relative hazard of an adverse cardiac event was performed only on HF participants categorized into 2 groups with H/M \<1.6 and H/M ≥1.6 using a Cox proportional hazards model.
COMPLETED
PHASE3
515 participants
Approximately 24 months from the date of administration of 123I-mIBG
2018-03-14
Participant Flow
A total of 753 participants were screened, of whom 197 were screen failures due to inclusion/exclusion criteria; 24 withdrawn at participant's request; 2 withdrawn at investigator's request and 15 failed to complete all screening procedures.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
453
|
62
|
|
Overall Study
COMPLETED
|
419
|
52
|
|
Overall Study
NOT COMPLETED
|
34
|
10
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal due to adverse event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
22
|
0
|
|
Overall Study
Protocol Violation
|
8
|
8
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
AdreView - Heart Failure
n=453 Participants
AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
|
Adreview - Control Group
n=62 Participants
AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
|
Total
n=515 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 12.38 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 10.84 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 12.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
351 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
394 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 24 months from the date of administration of 123I-mIBGPopulation: Primary efficacy population included 444 participants in HF group who received IMP and had a diagnostic (optimal/sub-optimal) 3 hour 50 minute planar image. Primary efficacy analysis was based on comparing only "Adreview HF" participants with low vs. high H/M and, therefore, did not include "Adreview Control" group.
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. Data analysis to assess the relative hazard of an adverse cardiac event was performed only on HF participants categorized into 2 groups with H/M \<1.6 and H/M ≥1.6 using a Cox proportional hazards model.
Outcome measures
| Measure |
AdreView-Heart Failure Group With High H/M Ratio
n=86 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=358 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=86, 355)
|
11 number of adverse cardiac events
|
111 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=86, 358)
|
11 number of adverse cardiac events
|
113 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=86, 352)
|
11 number of adverse cardiac events
|
112 number of adverse cardiac events
|
Adverse Events
AdreView - Heart Failure
Adreview - Control Group
Serious adverse events
| Measure |
AdreView - Heart Failure
n=453 participants at risk
AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
|
Adreview - Control Group
n=62 participants at risk
AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
|
|---|---|---|
|
Cardiac disorders
Atrioventricular Block
|
0.22%
1/453 • Number of events 1 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
0.00%
0/62 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.22%
1/453 • Number of events 1 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
0.00%
0/62 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
|
Infections and infestations
Bacteremia
|
0.22%
1/453 • Number of events 1 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
0.00%
0/62 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Chest Pain
|
0.22%
1/453 • Number of events 1 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
0.00%
0/62 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
|
Nervous system disorders
Abdominal Pain
|
0.22%
1/453 • Number of events 1 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
0.00%
0/62 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Syncope
|
0.22%
1/453 • Number of events 1 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
0.00%
0/62 • Up to 30 hours after administration of the IMP.
Analysis was performed on safety population that included all participants who received a dose of IMP.
|
Other adverse events
Adverse event data not reported
Additional Information
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