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.


CONCLUSIONS
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.
Jacobson
Arnold F
AF
GE Healthcare, 101 Carnegie Center, Princeton, NJ 08540, USA. arnold.jacobson@ge.com
Lombard
John
J
Banerjee
Gopa
G
Camici
Paolo G
PG
D019797:3-Iodobenzylguanidine; D015897:Comorbidity; D015340:Epidemiologic Research Design; D005260:Female; D006333:Heart Failure / Q000000981:diagnostic imaging* / Q000401:mortality*; D006801:Humans; D015994:Incidence; D038622:Internationality; D008297:Male; D019275:Radiopharmaceuticals; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D016019:Survival Analysis; D015996:Survival Rate; D015899:Tomography, Emission-Computed, Single-Photon / Q000706:statistics & numerical data*; D018487:Ventricular Dysfunction, Left / Q000000981:diagnostic imaging* / Q000401:mortality*
D019275:Radiopharmaceuticals; D019797:3-Iodobenzylguanidine