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| Name | Class |
|---|---|
| H2O Clinical LLC | INDUSTRY |
| Quintiles, Inc. | INDUSTRY |
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This aim of the study is to investigate the prognostic usefulness of AdreView™ imaging to identify those subjects with New York Heart Association (NYHA) Class II or III HF who will die during 60 months of follow-up from the date of administration of AdreView™ in prior studies MBG311, MBG312, or MBG312C (hereafter included in MBG312).
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Heart Failure patients (NYHA Class II or III) with left ventricular ejection fraction ≤35% at time of enrolment in MBG311 or MBG312.
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| Name | Affiliation | Role |
|---|---|---|
| Jose Zubeldia, M.D. | GE Healthcare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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 | 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. | 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. | Posted | Number | number of death or other adverse events | From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months |
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From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months
The main objective of the study was to monitor participants previously administered AdreView™ (123ImIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) to identify participants who died up to 60 months from the date of administration of 123I-mIBG, therefore, no safety evaluations performed in this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose M Zubeldia, M.D. | GE Healthcare | 011-44-1494-5431347 | jose.zubeldia@ge.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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