drugset / Trial / NCT00126438

Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

NCT00126438 ↗

Phase 3 Completed 515 enrolled GE Healthcare
NaSingle-groupOpen-labelDiagnostic

Summary

The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcome in subjects with heart failure and in comparison to subjects without cardiovascular disease.

Timeline

Start
2005-07
Primary completion
2008-07
Completion
2008-09

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry analysis (superiority or other test); AdreView-Heart Failure Group With High H/M Ratio vs AdreView-Heart Failure Group With Low H/M Ratio; p = 0.001; Hazard Ratio (HR) 0.36 (95% CI 0.18 to 0.73); NCT00126438 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject 123I-mIBG Diagnostic / imaging agent — —