drugset / Trial / NCT00126425

Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease

NCT00126425 ↗

Phase 3 Completed 587 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 outcomes in subjects with heart failure and in comparison to subjects without cardiovascular disease.

Timeline

Start
2005-07
Primary completion
2008-07
Completion
2008-12

Outcome

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

registry p =0.004; Hazard Ratio (HR) 0.44 (95% CI 0.23 to 0.83) NCT00126425 ↗

paper The hazard ratio for H/M > or =1.60 was 0.40 (p < 0.001); PMID 20188504 ↗

Drugs

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