At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 587 enrolled
Drug / intervention
123I-mIBG (meta-iodobenzylguanidine)drug
Likely dose
I-123 mIBG single doseAI-extracted
Key inclusion· 3
- ✓Established diagnosis of heart failure (NYHA Class II or III)
- ✓Reduced left ventricular ejection fraction (LVEF) ≤35%
- ✓Adult age
Key exclusion· 4
- ✕NYHA Class I or IV heart failure
- ✕History of diabetes mellitus (for healthy volunteers)
- ✕Signs/symptoms of neurological disease including Parkinson's Disease, multiple system atrophy, or Parkinsonian syndromes (for healthy volunteers)
- ✕Other diseases known to affect the sympathetic nervous system (for healthy volunteers)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multicenter, Phase 3 Study Evaluating the Prognostic Usefulness of I-123 mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event
In Brief
A Phase 3 clinical trial evaluating 123I-mIBG (meta-iodobenzylguanidine) for Heart Failure, Congestive. Completed, enrolled 587 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Congestive
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
First PostedAug 2005
Primary CompletionJul 2008
Study CompletionDec 2008
TodayJul 2026
First PostedAug 4, 2005
Enrollment StartJul 1, 2005
Primary CompletionJul 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.9 years ago
Interventions
123I-mIBG (meta-iodobenzylguanidine)drug
Single dose