GE touts ADMIRE-HF clinical results

GE Healthcare of Chalfont St. Giles, U.K., is touting two new clinical studies that offer encouraging results for its AdreView radiopharmaceutical in heart failure patients at risk for cardiac death, disease progression, or cardiac arrhythmias.

The studies from the ADMIRE-HF trial show that imaging of cardiac sympathetic nerves may be useful in assessing risk for cardiac arrhythmias and cardiac death. Details were presented today at the annual meeting of the American Heart Association (AHA) during its scientific sessions in Orlando, FL.

ADMIRE-HF is the combination of two identical phase III clinical trials, which were conducted in 96 centers in North America and Europe.

The first study was designed to demonstrate that if the cardiac nerves are damaged or reduced in number, as reflected by reduced AdreView radiotracer uptake in the heart, the patient is at increased risk for heart failure progression, arrhythmic events, and cardiac death.

The study examined 961 subjects who had New York Heart Association (NYHA) class II (83%) and III (17%) heart failure (66% ischemic, 34% nonischemic). In all, 905 patients had complete clinical data and measurements of plasma norepinephrine concentrations (NE) and B-type natriuretic peptide (BNP).

During median follow-up of 17 months, 75 of 905 subjects (8.3%) died; 51 deaths were due to cardiac causes, while 24 were deemed noncardiac.

The study demonstrated that age, BNP, and heart/mediastinum (H/M) ratio were three consistent contributors to prediction models of death in NYHA class II and III heart failure patients with left ventricular ejection fraction (LVEF) of less than or equal to 35%. LVEF contributed to prediction of cardiac death, but not all-cause mortality.

The second study consisted of a 17-month follow-up of 961 subjects, 86 (9%) of whom experienced arrhythmic events. Researchers concluded that cardiac imaging may help identify both NYHA class II and III heart failure patients with extremely low two-year risk of arrhythmic events and others with a higher than average likelihood of fatal and nonfatal arrhythmias.

Related Reading

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GE inks European Vscan evaluation deal, November 5, 2009

GE awarded $1.2M NIH grant, November 3, 2009

GE launches eHealth division, October 30, 2009

GE sells AgilTrac to Virtua, October 28, 2009

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