123I-mIBG scintigraphy to predict risk for adverse cardiac outcomes in heart failure patients: design of two prospective multicenter international trials.

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 (123)I-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 < or = 35% were eligible for the trials. Subjects underwent planar and SPECT (123)I-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 (123)I-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 (123)I-mIBG 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 (123)I-mIBG scintigraphy in assessing prognosis and developing management strategies for patients with heart failure.