Phase 3
Completed N=587
Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease
Heart Failure, Congestive
Source: ClinicalTrials.gov NCT00126425 ↗
Enrolled (actual)
587
Serious AEs
0.2%
Results posted
Dec 2016
Primary outcomePrimary: 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 — 14; 100; 14; 100 number of adverse cardiac events — p==0.004
◆ Published Evidence
Highly cited
868citations · ~54 / year
Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study.
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.
Linked Publications (3)
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Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study.
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Influence of diabetes mellitus on prognostic utility of imaging of myocardial sympathetic innervation in heart failure patients.
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Predicting Risk Versus Predicting Potential Survival Benefit Using 123I-mIBG Imaging in Patients With Systolic Dysfunction Eligible for Implantable Cardiac Defibrillator Implantation: Analysis of Data From the Prospective ADMIRE-HF Study.
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 |
14; 100; 14; 100; 14; 100 | =0.004 sig |
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 are not eligible if they have a history diabetes mellitus, signs/symptoms of neurological disease (eg, 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 are not eligible.
Data sourced from ClinicalTrials.gov (NCT00126425) and the linked publication. 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. Informational only — not medical advice.