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123I-mIBG Scintigraphy to predict risk for adverse cardiac outcomes in heart failure patients: Design of two prospective multicenter international trials
Authors:Arnold F Jacobson MD  PhD  John Lombard MS  Gopa Banerjee MS  Paolo G Camici MD  FRCP
Institution:(1) GE Healthcare, 101 Carnegie Center, Princeton, NJ 08540, USA;(2) Medical Research Council Clinical Sciences Centre and National Heart and Lung Institute, Imperial College School of Medicine, London, United Kingdom
Abstract:Background  ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) consists of two identical prospective open-label, multicenter, phase 3 studies (MBG311 and MBG312) evaluating the prognostic usefulness of 123I-mIBG scintigraphy for identifying subjects with heart failure who will experience a major adverse cardiac event. Methods  Subjects with NYHA class II and III heart failure and left ventricular ejection fraction ≤35% were eligible for the trials. Subjects underwent planar and SPECT 123I-mIBG myocardial imaging, as well as echocardiography and gated SPECT 99mTc-tetrofosmin myocardial perfusion imaging. Subjects are then monitored on a regular basis for 2 years. Time to first occurrence of one of the following—NYHA class progression; potentially life-threatening arrhythmic event (including ICD discharge); or cardiac death, as verified by an independent adjudication panel—will be analyzed in comparison to quantitative parameters derived from 123I-mIBG imaging. The primary efficacy analysis will employ the heart/mediastinum ratio on 4-hour delayed planar imaging, while secondary efficacy analyses will examine quantitative results from both planar and SPECT 123I-mIBG images, as well as from 99mTc-tetrofosmin SPECT and echocardiography. Conclusion  The results of the ADMIRE-HF trials will provide prospective validation of the potential role of 123I-mIBG scintigraphy in assessing prognosis and developing management strategies for patients with heart failure. Funding Source: GE Healthcare.
Keywords:Sympathetic innervation  myocardial scintigraphy            123I-mIBG
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