Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00126425 | Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease | PHASE3 | COMPLETED | 587 | — | — | Jul 1, 2005 | Dec 1, 2008 | Dec 13, 2016 | 1 | United States |
| NCT00126438 | Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease | PHASE3 | COMPLETED | 515 | — | — | Jul 1, 2005 | Sep 1, 2008 | Mar 14, 2018 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 123I-mIBG (meta-iodobenzylquanidine | EXPERIMENTAL | Single dose |
| 123I-mIBG (meta-iodobenzylguanidine) | EXPERIMENTAL | Single dose |
| Name | Type | Description |
|---|---|---|
| 123I-mIBG (meta-iodobenzylguanidine) | DRUG | Single dose |
Inclusion Criteria: * Study subjects must be adults with an established diagnosis of heart failure (New York Heart Association Class II or III) and reduced left ventricular ejection fraction (LVEF) (≤ 35%) or be healthy volunteers without heart disease. Exclusion Criteria: * Healthy volunteers ar...