Heart Failure (HF)
Conditions
Keywords
Myocardial sympathetic innervation, Heart failure (HF), Nuclear imaging, Radiopharmaceutical
Brief summary
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).
Interventions
None listed
Sponsors
H2O Clinical LLC
Quintiles, Inc.
GE Healthcare
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject was a HF subject who had signed informed consent for MBG311 or MBG312. * The subject was administered AdreView™ in MBG311 or MBG312. * The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311 and MBG312, and those images were read and judged diagnostic by at least 2 blinded readers. * In addition, all subjects must meet 1 of the following 3 inclusion criteria. * If the subject can be located, he/she provides informed consent to allow the investigator access to medical records and/or gives permission for the investigator to speak to treating physicians. * If the subject can be located and he/she declines to provide informed consent, the IRB/EC provides a waiver of consent to allow the investigator to record that the subject is alive. * If the subject cannot be located, the IRB/EC provides a waiver of consent to allow the investigator to access available medical records for care provided subsequent to last date of subject participation in MBG311, MBG312, and/or MBG313 and/or to allow collection of data from publicly available sources.
Exclusion criteria
* The subject withdrew or was withdrawn from MBG311 or MBG312 because of a protocol violation. * The subject underwent heart transplantation during MBG311, MBG312, or MBG313. * The subject was recorded to have died during MBG311, MBG312, or MBG313. * The subject voluntarily withdrew from MBG311, MBG312, or MBG313, and the IRB/EC has not provided a waiver to allow recording of subject survival status in such an instance. * The subject cannot be located, cannot be contacted, and no information can be found to establish survival status beyond the date of last contact in MBG311, MBG312, or MBG313, including information available as a result of an IRB/EC-approved waiver.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 964 |
| Total | 964 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 101 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other than specified above | 169 |
| Overall Study | Protocol Violation | 36 |
Baseline characteristics
| Characteristic | AdreView™- Heart Failure Group |
|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 11.85 |
| Sex: Female, Male Female | 192 Participants |
| Sex: Female, Male Male | 772 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AdreView™- Heart Failure Group | 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 |
| AdreView™- Heart Failure Group | 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 |
Comparison: AdreView-Heart Failure Group with H/M \<1.60 vs. H/M ≥1.60:~Data analysis was performed using Cox proportional hazards model to demonstrate the relationship of consensus numeric H/M ratio and time to adverse cardiac events to identify participants with higher risk of death. Hazard (risk) of a death for a participant with H/M ratio at time t was expressed as Hl (t)/Hh (t)=Ψ,where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively.p-value: <0.000195% CI: [0.3227, 0.6156]Cox proportional hazards model