Phase 3
N=515
Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease
Heart Failure, Congestive
Bottom Line
View on ClinicalTrials.gov: NCT00126438 ↗Enrolled (actual)
515
Serious AEs
1.2%
Results posted
May 2017
Primary outcome: Primary: Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio — 11; 111; 11; 113 number of adverse cardiac events — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 123I-mIBG (meta-iodobenzylguanidine) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio |
11; 111; 11; 113; 11; 112 | 0.001 sig |
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.
Eligibility Criteria
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 were not eligible if they had a history of diabetes mellitus, signs/symptoms of neurological disease (e.g., Parkinson's Disease, multiple system atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic nervous system.
- Subjects with New York Heart Association Class I or IV heart failure were not eligible.
- Subjects were excluded if they had previously received 123I-mIBG or 131I-mIBG or participated in a clinical study involving investigational medicinal product or devices within 30 days.
- Subjects that had a pacemaker or had received defibrillation, anti-tachycardia pacing or cardioversion to treat a previous arrhythmic event or had an ICD inserted within 30 days before study entry are not eligible.
Data sourced from ClinicalTrials.gov (NCT00126438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.