CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 515 enrolled
Drug / intervention
123I-mIBG (meta-iodobenzylguanidine)drug
Likely dose
123I-mIBG single dose (specific dose not stated)AI-extracted
Key inclusion· 3
  • ✓Established diagnosis of heart failure, NYHA Class II or III
  • ✓Reduced left ventricular ejection fraction (LVEF) ≤35%
  • ✓Healthy volunteers without heart disease (alternative enrollment group)
Key exclusion· 8
  • ✕NYHA Class I or IV heart failure
  • ✕History of diabetes mellitus (in healthy volunteers)
  • ✕Signs/symptoms of neurological disease (e.g., Parkinson's Disease, multiple system atrophy, Parkinsonian syndromes) in healthy volunteers
  • ✕Other diseases known to affect the sympathetic nervous system (in healthy volunteers)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00126438
NCT00126438Phase 3Completed
CompareCT.gov

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

GE Healthcare·interventional·Posted Aug 4, 2005·Updated Mar 14, 2018

In Brief

A Phase 3 clinical trial evaluating 123I-mIBG (meta-iodobenzylguanidine) for Heart Failure, Congestive. Completed, enrolled 515 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 outcome 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
First PostedAug 4, 2005
Enrollment StartJul 1, 2005
Primary CompletionJul 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.9 years ago

Interventions

123I-mIBG (meta-iodobenzylguanidine)drug

Single Dose