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 99m Tc-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-m IBG 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-m IBG images, as well as from 99m Tc-tetrofosmin SPECT and echocardiography. Conclusion: The results of the ADMIRE-HF trials will provide prospective validation of the potential role of 123I-m IBG scintigraphy in assessing prognosis and developing management strategies for patients with heart failure.
- Myocardial scintigraphy
- Sympathetic innervation
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Radiology Nuclear Medicine and imaging