Trial Outcomes & Findings for Phase 4 Study to Demonstrate Prognostic Usefulness of AdreView™ Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience Death During 60 Months Follow-up. (NCT NCT02127307)

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. 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, as reflected by the H/M ratio, for identifying HF participants at lower risk of death during 60 months of follow-up.

Recruitment status

COMPLETED

Target enrollment

964 participants

Primary outcome timeframe

From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months

Results posted on

2017-03-28

Participant Flow

In the present study GE-122-016 (NCT02127307), participants previously administered AdreView™ (123ImIBG \[meta-iodobenzylguanidine\]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were followed to identify who died during 60 months of follow-up from the date of administration of 123I-mIBG.

Of 964 heart failure (HF) participants included in the efficacy population of MBG311 (NCT00126425) and MBG312 (NCT00126438), 694 were contacted in this study as 101 participants died and 169 were not contacted due to participant consent not obtained and/or some sites declined to participate.

Participant milestones

Participant milestones
Measure	AdreView™- Heart Failure Group HF participants who were administered AdreView™ (123I-mIBG \[meta-iodobenzylguanidine\]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
Overall Study STARTED	964
Overall Study COMPLETED	656
Overall Study NOT COMPLETED	308

Reasons for withdrawal

Reasons for withdrawal
Measure	AdreView™- Heart Failure Group HF participants who were administered AdreView™ (123I-mIBG \[meta-iodobenzylguanidine\]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
Overall Study Protocol Violation	36
Overall Study Lost to Follow-up	2
Overall Study Death	101
Overall Study Other than specified above	169

Baseline Characteristics

Phase 4 Study to Demonstrate Prognostic Usefulness of AdreView™ Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience Death During 60 Months Follow-up.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AdreView™- Heart Failure Group n=964 Participants HF participants who were administered AdreView™ (123I-mIBG \[meta-iodobenzylguanidine\]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
Age, Continuous	62.4 years STANDARD_DEVIATION 11.85 • n=5 Participants
Sex: Female, Male Female	192 Participants n=5 Participants
Sex: Female, Male Male	772 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months

Population: Efficacy population was 961 participants who received investigational medicinal product (IMP) and had a diagnostic 3 hour 50 minute planar image in MBG311 or MBG312. Here, 'n' signifies number of participants with available data for specified category.

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. 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, as reflected by the H/M ratio, for identifying HF participants at lower risk of death during 60 months of follow-up.

Outcome measures

Outcome measures
Measure	AdreView™- Heart Failure Group n=961 Participants HF participants who were administered AdreView™ (123I-mIBG \[meta-iodobenzylguanidine\]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
Relationship Between the Occurrence of Death and 123I-mIBG Uptake on Planar Scintigraphy With Heart to Mediastinum (H/M) Ratio of <1.60 vs H/M ≥1.60 Participants with H/M ratio <1.60 (n=760)	292 number of death or other adverse events
Relationship Between the Occurrence of Death and 123I-mIBG Uptake on Planar Scintigraphy With Heart to Mediastinum (H/M) Ratio of <1.60 vs H/M ≥1.60 Participants with H/M ratio ≥1.60 (n=201)	42 number of death or other adverse events

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: 011-44-1494-5431347

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