Congestive Heart Failure
Conditions
Keywords
Heart Failure, MIBG, 123I-mIBG
Brief summary
The study was designed to study the utility of meta-iodobenzylguanidine (123I-mIBG) imaging to identify those participants with heart failure who would experience an adverse cardiac event during 24 months of follow-up from the administration date of 123I-mIBG in previous studies MBG311 or MBG312.
Interventions
DRUGI-123 mIBG
This was an observational study. Participants were previously dosed in separate study.
Sponsors
GE Healthcare
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject was a Heart Failure subject who signed informed consent for MBG311, MBG312, or MBG312C. * The subject was administered 123I-mIBG in MBG311, MBG312, or MBG312C. * The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311, MBG312, or MBG312C. * The subject agreed to allow the investigator access to medical records, including those relating to subject death should this occur.
Exclusion criteria
* The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C. * The subject was considered lost-to-follow-up (6 months without contact) in MBG311, MBG312, or MBG312C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status | From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months | The numerical value of 123 I-mIBG uptake (H/M ratio) 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. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis. |
Countries
United States
Participant flow
Recruitment details
In the present study MBG313 (NCT00785044), participants previously administered AdreView™ (123I-mIBG \[meta-iodobenzylguanidine\]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months from the date of administration of 123I-mIBG.
Pre-assignment details
Of 964 heart failure (HF) participants included in efficacy population of MBG311 (NCT00126425) and MBG312 (NCT00126438), 471 participants signed informed consent and enrolled into extension MBG313 study and provided additional efficacy data. New data from MBG313 study combined with data collected in MBG311 and MBG312 studies for efficacy analysis.
Participants by arm
| Arm | Count |
|---|---|
| AdreView™ - Heart Failure Group HF participants administered AdreView™ (123I-mIBG \[meta-iodobenzylguanidine\]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of ACEs. | 964 |
| Total | 964 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 77 |
| Overall Study | Dosed at non-participating sites | 152 |
| Overall Study | Lost to Follow-up | 266 |
| Overall Study | Withdrawal by Subject | 1 |
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
Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status
The numerical value of 123 I-mIBG uptake (H/M ratio) 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. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.
Time frame: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months
Population: Efficacy population was 961 participants who received IMP and had a consensus H/M ratio on 3 hour 50 minute planar image in MBG 311 or MBG 312. Here, number of participant analyzed = number of participants with available data for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AdreView™ - HF Group (With No Adverse Cardiac Events) | Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status | 1.451 Ratio | Standard Deviation 0.2033 |
| AdreView™- HF Group (With Adverse Cardiac Events) | Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status | 1.394 Ratio | Standard Deviation 0.1885 |
Comparison: Analysis was performed on all HF participants from both groups AdreView™ - HF Group (With No Adverse Cardiac Events) and AdreView™ - HF Group (With Adverse Cardiac Events) based on H/M ratio.p-value: <0.00195% CI: [0.532, 0.63]Z-statistic